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【MDR CE 宝】
【MDR CE 宝】
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MDR CE宝-法规汇编
| 编号 | 法规编号 | 标题 | 年份 | 类别 | 语言 |
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| MR001 | MDR 2017/745-24.04.2020-001.001 | MR001 MDR 2017/745-24.04.2020-001.001 REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 201 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
2020 | 法规 | EN | |
| MR001 | MDR 2017/745-05.05.2017-000.002 | MR001 MDR 2017/745-05.05.2017-000.002 REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 201 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
2017 | 法规 | EN | |
| MR002 | IVDR 2017/746 | REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU | 2017 | 法规 | EN | |
| MR003 | 2020/561 | amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions | 2020 | 法规 | EN | |
| MR004 | IVDD 98/79/EC | DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices | 1998 | 法规 | EN | |
| MR005 | MDD 93/42 / EEC | COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices | 1993 | 法规 | EN | |
| MR006 | AIMD 90/385/EEC | COUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) | 1990 | 法规 | EN | |
| MR007 | MEDDEV 2.1/1 | Definitions of 'medical devices', 'accessory' and 'manufacturer | 1994 | 指南 | EN | |
| MR008 | MEDDEV 2.1/2 rev.2 | Field of application of directive 'active implantable medical devices' | 1994 | 指南 | EN | |
| MR009 | MEDDEV 2.1/2.1 | Treatment of computers used to program implantable pulse generators | 1998 | 指南 | EN | |
| MR010 | MEDDEV 2.1/3 rev.3 | Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative | 2009 | 指南 | EN | |
| MR011 | MEDDEV 2.1/4 | Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective | 1994 | 指南 | EN | |
| MR012 | MEDDEV 2.1/5 | Medical devices with a measuring function | 1998 | 指南 | EN | |
| MR013 | MEDDEV 2.1/6 | Qualification and classification of stand alone software | 2016 | 指南 | EN | |
| MR014 | MEDDEV 2.2/1 rev.1 | GUIDELINES RELATING TO THE APPLICATION OF : THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES-EMC requirements | 1998 | 指南 | EN | |
| MR015 | MEDDEV 2.2/3 rev.3 | GUIDELINES RELATING TO THE APPLICATION OF : THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES-USE-by-date |
1998 | 指南 | EN | |
| MR016 | MEDDEV 2.2/4 | Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products | 2012 | 指南 | EN | |
| MR017 | MEDDEV 2.4/1 rev.9 | Classification of medical devices | 2010 | 指南 | EN | |
| MR018 | MEDDEV 2.5/3 rev.2 | Subcontracting quality systems related | 1998 | 指南 | EN | |
| MR019 | MEDDEV 2.5/5 rev.3 | Translation procedure | 1998 | 指南 | EN | |
| MR020 | MEDDEV 2.5/6 rev.1 | Homogenous batches (verification of manufacturers' products) | 1998 | 指南 | EN | |
| MR021 | MEDDEV 2.5/7 rev.1 | Conformity assessment of breast implants | 1998 | 指南 | EN | |
| MR022 | MEDDEV 2.5/9 rev.1 | Evaluation of medical devices incorporating products containing natural rubber latex | 2004 | 指南 | EN | |
| MR023 | MEDDEV 2.5/10 | Guideline for authorised representatives | 2012 | 指南 | EN | |
| MR024 | MEDDEV 2.7/1 rev.4 | Clinical evaluation: Guide for manufacturers and notified bodies | 2016 | 指南 | EN | |
| MR025 | MEDDEV 2.7/1 Appendix 1 | Appendix 1: Clinical evaluation on coronary stents | 2008 | 指南 | EN | |
| MR026 | MEDDEV 2.7/2 rev.2 | Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC and 93/42/EC | 2015 | 指南 | EN | |
| MR027 | MEDDEV 2.7/3 rev. 3 | Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC | 2015 | 指南 | EN | |
| MR028 | MEDDEV 2.7/4 | Guidelines on clinical investigations: a guide for manufacturers and notified bodies | 2010 | 指南 | EN | |
| MR029 | MEDDEV 2.10/2 rev.1 | Designation and monitoring of notified bodies within the framework of EC directives on medical devices | 2001 | 指南 | EN | |
| MR030 | MEDDEV 2.12/1 rev.8 | Guidelines on a medical devices vigilance system | 2013 | 指南 | EN | |
| MR031 | MEDDEV 2.12/1 rev.8 | Additional guidance on MEDDEV 2.12/1 rev.8 | 2019 | 指南 | EN | |
| MR032 | MEDDEV 2.12/1 rev 7 | Field Safety Corrective Action-FSCA | 2012 | 指南 | EN | |
| MR033 | DSVG 00 | Introduction to device specific vigilance guidance | 2014 | 指南 | EN | |
| MR034 | DSVG 01 | Cardiac ablation vigilance reporting guidance | 2016 | 指南 | EN | |
| MR035 | DSVG 02 | Coronary stents vigilance reporting guidance | 2015 | 指南 | EN | |
| MR036 | DSVG 03 | Cardiac implantable electronic devices (CIED) | 2019 | 指南 | EN | |
| MR037 | DSVG 04 | Breast implants | 2019 | 指南 | EN | |
| MR038 | MEDDEV 2.12/2 rev.2 | Post market clinical follow-up studies | 2012 | 指南 | EN | |
| MR039 | MEDDEV 2.13 rev.1 | Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ98/C 242/05) | 1998 | 指南 | EN | |
| MR040 | MEDDEV 2.14/1 rev.2 | IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES | 2012 | 指南 | EN | |
| MR041 | MEDDEV 2.14/2 rev.1 | Research use only products | 2004 | 指南 | EN | |
| MR042 | MEDDEV 2.14/3 rev.1 | Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices | 2007 | 指南 | EN | |
| MR043 | MEDDEV 2.14/4 | CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP | 2012 | 指南 | EN | |
| MR044 | MEDDEV. 2.15 Rev.3 | Committees/working groups contributing to the implementation of the medical device directives December 2008 | 2008 | 指南 | EN | |
| MR045 | MDCG 2020-18 | MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers | 2020 | 指南 | EN | |
| MR046 | MDCG 2019-2 | Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 | 2019 | 指南 | EN | |
| MR047 | MDCG 2019-1 | MDCG guiding principles for issuing entities rules on basic UDI-DI | 2020 | 指南 | EN | |
| MR048 | MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | 2018 | 指南 | EN | |
| MR049 | MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to article 16 | 2018 | 指南 | EN | |
| MR050 | MDCG 2018-5 | UDI assignment to medical device software | 2018 | 指南 | EN | |
| MR051 | MDCG 2018-4 | Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | 2018 | 指南 | EN | |
| MR052 | MDCG 2018-3 Rev.1 | Guidance on UDI for systems and procedure packs | 2020 | 指南 | EN | |
| MR053 | MDCG 2018-2 | Future EU medical device nomenclature - Description of requirements | 2018 | 指南 | EN | |
| MR054 | MDCG 2018-1 v3 | Guidance on basic UDI-DI and changes to UDI-DI | 2020 | 指南 | EN | |
| MR055 | MDCG 2020-15 | MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States | 2020 | 指南 | EN | |
| MR056 | MDCG 2019-5 | Registration of legacy devices in EUDAMED | 2019 | 指南 | EN | |
| MR057 | MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | 2019 | 指南 | EN | |
| MR058 | MDCG 2021-1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | 2021 | 指南 | EN | |
| MR059 | MDCG 2020-17 | Questions and Answers related to MDCG 2020-4 | 2020 | 指南 | EN | |
| MR060 | MDCG 2020-14 | Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) | 2020 | 指南 | EN | |
| MR061 | MDCG 2020-12 | Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues | 2020 | 指南 | EN | |
| MR062 | MDCG 2020-11 | Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulatio | 2020 | 指南 | EN | |
| MR063 | MDCG 2020-4 | Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions | 2020 | 指南 | EN | |
| MR064 | MDCG 2020-3 | Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD | 2020 | 指南 | EN | |
| MR065 | MDCG 2019-14 | Explanatory note on MDR codes | 2019 | 指南 | EN | |
| MR066 | MDCG 2019-13 | Guidance on sampling of devices for the assessment of the technical documentation | 2019 | 指南 | EN | |
| MR067 | MDCG 2019-12 | Designating authority's final assessment form: Key information (EN) | 2019 | 指南 | EN | |
| MR068 | MDCG 2019-10 rev.1 | Application of transitional provisions concerning validity of certificates issued in accordance to the directives | 2019 | 指南 | EN | |
| MR069 | MDCG 2019-6 v2 | Questions and answers: Requirements relating to notified bodies | 2019 | 指南 | EN | |
| MR070 | MDCG 2018-8 | Guidance on content of the certificates, voluntary certificate transfers | 2018 | 指南 | EN | |
| MR071 | NBOG BPG 2017-1 | Best practice guidance on designation and notification of conformity assessment bodies | 2018 | 指南 | EN | |
| MR072 | NBOG BPG 2017-2 | Best practice guidance on the information required for personnel involved in conformity assessment | 2018 | 指南 | EN | |
| MR073 | NBOG F 2017-8 | Review of qualification for the authorisation of personnel(IVDR) | 2018 | 指南 | EN | |
| MR074 | NBOG F 2017-7 | Review of qualification for the authorisation of personnel (MDR) | 2018 | 指南 | EN | |
| MR075 | NBOG F 2017-6 | Preliminary assessment review template (IVDR) | 2018 | 指南 | EN | |
| MR076 | NBOG F 2017-5 | Preliminary assessment review template (MDR) | 2018 | 指南 | EN | |
| MR077 | NBOG F 2017-4 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) | 2018 | 指南 | EN | |
| MR078 | NBOG F 2017-3 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) | 2018 | 指南 | EN | |
| MR079 | NBOG F 2017-2 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices Regulation (IVDR) | 2018 | 指南 | EN | |
| MR080 | NBOG F 2017-1 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) | 2018 | 指南 | EN | |
| MR081 | MDCG2020-13 | Clinical evaluation assessment report template | 2020 | 指南 | EN | |
| MR082 | MDCG 2020-10/1 | Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form |
2020 | 指南 | EN | |
| MR083 | MDCG 2020-10/2 |
Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form |
2020 | 指南 | EN | |
| MR084 | MDCG 2020-8 | Guidance on PMCF evaluation report templateC | 2020 | 指南 | EN | |
| MR085 | MDCG 2020-7 | Guidance on PMCF plan template | 2020 | 指南 | EN | |
| MR086 | MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices | 2020 | 指南 | EN | |
| MR087 | MDCG 2020-5 | Guidance on clinical evaluation – Equivalence | 2020 | 指南 | EN | |
| MR088 | MDCG 2019-9 | Summary of safety and clinical performance | 2019 | 指南 | EN | |
| MR089 | MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | 2020 | 指南 | EN | |
| MR090 | MDCG 2019-16 rev.1 | Guidance on cybersecurity for medical devices | 2019 | 指南 | EN | |
| MR091 | MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2019 | 指南 | EN | |
| MR092 | MDCG 2020-16 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | 2020 | 指南 | EN | |
| MR093 | MDCG 2020-9 | Regulatory requirements for ventilators and related accessories | 2020 | 指南 | EN | |
| MR094 | MDCG 2020-2 rev.1 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | 2020 | 指南 | EN | |
| MR095 | MDCG 2019-15 rev.1 | Guidance notes for manufacturers of class I medical devices | 2019 | 指南 | EN | |
| MR096 | MDCG 2019-8 v2 | Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | 2020 | 指南 | EN | |
| MR097 | MDCG 2019-7 | Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) | 2019 | 指南 | EN | |
| MR098 | MDCG 2019-3 rev.1 | Interpretation of article 54(2)b | 2020 | 指南 | EN | |
| MR099 | Guidance on regulatory requirements for medical face masks Options for supporting production and/or placing on the market of medical face masks in the context of COVID-19 pandemic | 2020 | 指南 | EN | ||
| MR100 | Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context | 2020 | 指南 | EN | ||
| MR101 | Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties | 2019 | 指南 | EN | ||
| MR102 | MDCG2020-14 | Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) | 2020 | 指南 | EN | |
| MR103 | GHTF/SG4/N83:2010 | Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers –Part 4: Multiple Site Auditing | 2010 | 指南 | EN | |
| MR104 | GHTF/SG4/N84:2010 | Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of Manufacturer Control of Suppliers | 2010 | 指南 | EN | |
| MR105 | Guidance Notes for Manufacturers of Custom-Made Medical Devices | 2010 | 指南 | EN | ||
| MR106 | Guidance document on Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements | 2006 | 指南 | EN | ||
| MR107 | GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES | 2009 | 指南 | EN | ||
| MR108 | Recommendation-NB-MED-2_7-1_rev2 | Recommendation-NB-MED-2_7-1_rev2 Guidance on clinicals | 1998 | 指南 | EN | |
| MR109 | CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions | 2018 | 其他 | EN | ||
| MR110 | Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 | 2020 | 其他 | EN | ||
| MR111 | How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context | 2020 | 其他 | EN | ||
| MR112 | For the relation between the DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES and Directive 89/686/EEC concerning personal protective equipment, please see the Commission services | 2009 | 其他 | EN | ||
| MR113 | NBM-003-19 | Joint NB-Position Paper on Spinal Classification per the MDR | 2018 | 其他 | EN | |
| MR114 | NBM-046-18 | One Year of Application | 2018 | 其他 | EN | |
| MR115 |
Guidance for the Interpretation and Implementation of the Commission Recommendation on audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU)“Testing during unannounced Audits” V 2.3 October,13th, 2014 |
2014 | 其他 | EN | ||
| MR116 | Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012 Version 1.1 October 13th, 2014 |
2014 | 其他 | EN | ||
| MR117 | Recommendation-NB-MED-2.5.2 rec 2 | Recommendation-NB-MED-2.5.2 rec 2 Reporting of design changes and changes of the quality system | 2008 | 其他 | EN | |
| MR118 | NB-MED/2.5.1/Rec5 | Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation | 2000 | 其他 | EN | |
| MR119 | Recommendation-NB-MED-2_15-1_rev3 | Recommendation-NB-MED-2_15-1_rev3 Voluntary certification at an intermediate stage of manufacture | 2000 | 其他 | EN | |
| MR120 | Recommendation-NB-MED-2_13-2_rev3 | Recommendation-NB-MED-2_13-2_rev3 CE-Marking of established IVD devices | 2000 | 其他 | EN | |
| MR121 | NB-MED/2.13/Rec1 | Recommendation-NB-MED-2_13-1_rev3 CE-Marking of pre-MDD devices | 1998 | 其他 | EN | |
| MR122 | NB-MED/2.12/Rec1 | Recommendation-NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS) | 2000 | 其他 | EN | |
| MR123 | Recommendation-NB-MED-2_7-3_rev5 | Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data | 1999 | 其他 | EN | |
| MR124 | Recommendation-NB-MED-2_5_5-Rec5 | Recommendation-NB-MED-2_5_5-Rec5 Conformity Assessment of Own Brand Labelling | 2005 | 其他 | EN | |
| MR125 | Recommendation-NB-MED-2_5_5 Rec2 | Recommendation-NB-MED-2_5_5 Rec2-Conformity assessment procedures for hip, knee and shoulder total | 2006 | 其他 | EN | |
| MR126 | NB-MED/2.5.5/Rec4 | Recommendation-NB-MED-2_5_5-4_rev2 Assessment of the sensitivity of In Vitro Diagnostic Medical | 2001 | 其他 | EN | |
| MR127 | NB-MED/2.5.5/Rec2 | Recommendation-NB-MED-2_5_5-2_rev9 Combination of CE-marked and non-CE-marked medical devices and non-medical devices | 2001 | 其他 | EN | |
| MR128 | NB-MED/2.5.5/Rec1 | Recommendation-NB-MED-2_5_5-1_rev5 Conformity assessment procedures of breast implants | 2000 | 其他 | EN | |
| MR129 | NB-MED-2_5_4-2_rev3 | Recommendation-NB-MED-2_5_4-2_rev3 Verification of Manufactured Products for the IVD Directive | 2000 | 其他 | EN | |
| MR130 | NB-MED-2_5_4-1_rev4 | Recommendation-NB-MED-2_5_4-1_rev4 Homogeneous batches | 2000 | 其他 | EN | |
| MR131 | NB-MED-2_5_2-3_rev9 | Recommendation-NB-MED-2_5_2-3_rev9 Translation procedure | 2000 | 其他 | EN | |
| MR132 | NB-MED-2_5_2-1_rev4 | Recommendation-NB-MED-2_5_2-1_rev4 Subcontracting – QS related | 2000 | 其他 | EN | |
| MR133 | NB-MED-2_5_1-6_rev4 | Recommendation-NB-MED-2_5_1-6_rev4 Renewal of EC Design-Examination and Type-Examination | 2000 | 其他 | EN | |
| MR134 | NB-MED-2_5_1-4_rev4 | Recommendation-NB-MED-2_5_1-4_rev4 Content of mandatory certificates | 1998 | 其他 | EN | |
| MR135 | NB-MED-2_2 Rec1 | Recommendation-NB-MED-2_2 Rec1 EMC requirements | 1998 | 其他 | EN | |
| MR136 | NB-MED-2_2-4_rev5 | Recommendation-NB-MED-2_2-4_rev5 Software and Medical Devices | 2001 | 其他 | EN | |
| MR137 | NB-MED/2.2/Rec3 | Recommendation-NB-MED-2_2-3_rev4 ‘Use-by’ date for Medical Devices | 2000 | 其他 | EN | |
| MR138 | NB-MED-2_2-2_rev3 | Recommendation-NB-MED-2_2-2_rev3 Treatment of computer used to program Active Implantable Medical Devices (AIMD) | 2000 | 其他 | EN | |
| MR139 | NB-MED-2_1-5_rev5 | Recommendation-NB-MED-2_1-5_rev5 Placing on the market of fully refurbished medical devices | 2000 | 其他 | EN | |
| MR140 | NB-MED-2_1-4_rev7 | Recommendation-NB-MED-2_1-4_rev7 Medical devices with a measuring function | 1998 | 其他 | EN | |
| MR141 | NB-MED-2_1-3_rev2 | Recommendation-NB-MED-2_1-3_rev2 Accessories and other parts for Active Implantable Medical | 1996 | 其他 | EN | |
| MR142 | NB-MED-2_1-2_rev5 | Recommendation-NB-MED-2_1-2_rev5 Explanation of Terms | 1998 | 其他 | EN | |
| MR143 | NB-MED-2_1-1_rev4 | Recommendation-NB-MED-2_1-1_rev4 Representative Sample | 2000 | 其他 | EN | |
| MR144 | NB-Med_2007-04 | Recommendation_Vigilance_after NB-Med_2007-04 | 2007 | 其他 | EN | |
| MR145 | NB-MED letter to MS on 2007_47 implementation | 2009 | 其他 | EN | ||
| MR146 | Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 | 2020 | 其他 | EN | ||
| MR147 | Insulin Infusion Pumps and Integrated meter systems | 2020 | 其他 | EN | ||
| MR148 | Instructions for use for reusable & re-sterilisable medical devices) e | 2020 | 其他 | EN | ||
| MR149 | Requirements for in vitro diagnostic kits measuring parameters which can be used for evaluating the risk of trisomy 21 | 2006 | 其他 | EN | ||
| MR150 | Informative document of the Commission’s services on placing on the market of medical devices | 2010 | 其他 | EN | ||
| MR151 | Information on the Customs Union Agreement with Turkey in the field of medical devices | 2010 | 其他 | EN | ||
| MR152 | DECISION No 1/2006 OF THE EC-TURKEY ASSOCIATION COUNCIL of 15 May 2006 | 2006 | 其他 | EN | ||
| MR153 | Statement of Turkey – EC Customs Union Joint Committee on the implementation of Article 1 of Decision 1/2006 | 2006 | 其他 | EN | ||
| MR154 | Information on the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery | 2009 | 其他 | EN | ||
| MR155 | Information on the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment | 2009 | 其他 | EN | ||
| MR156 | Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 93/42/EEC and 98/8/EC | 2009 | 其他 | EN | ||
| MR157 | Information on the Medical Devices Directives in relation to medical device own brand labellers | 2015 | 其他 | EN | ||
| MR158 | 2013/172/EU | Commission Recommendation 2013/172/EU of 5 April 2013 on a common framework for a unique device identification system for medical devices in the Union | 2013 | 其他 | EN | |
| MR159 | 2013/473/EU | Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices | 2013 | 其他 | EN | |
| MR160 | 2005/50 / EC | COMMISSION DIRECTIVE 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices |
2005 | 其他 | EN | |
| MR161 | 2003/12/EC | Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (Text with EEA relevance) | 2003 | 其他 | EN | |
| MR162 | (EU) 2020/666 | Commission Implementing Regulation (EU) 2020/666 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies – OJ L 153 of 10 May 2020 |
2020 | 其他 | EN | |
| MR163 | 2020/350 | amending Decision 2002/364/EC as regards definitions of first–line assays and confirmatory assays, requirements for devices for self-testing and requirements for HIV and HCV rapid tests, confirmatory and supplementary assays |
2020 | 其他 | EN | |
| MR164 | 2002/364/EC | COMMISSION DECISION of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices |
2011 | 其他 | EN | |
| MR165 | 2002/364/EC | Corrigendum to Commission Decision 2009/886/EC of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices | 2009 | 其他 | EN | |
| MR166 | 2002/364/EC | COMMISSION DECISION of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnosticmedical devices | 2009 | 其他 | EN | |
| MR167 | (EU) 2017/1445 | COMMISSION IMPLEMENTING DECISION (EU) 2017/1445 of 8 August 2017 on the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry (Vaccinium macrocarpon), is to prevent or treat cystitis |
2017 | 其他 | EN | |
| MR168 | (EU) 920/2013 | COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices |
2013 | 其他 | EN | |
| MR169 | COMMISSION DECISION of 19 April 2010 on the European Databank on Medical Devices (Eudamed) |
2010 | 其他 | EN | ||
| MR170 | (EU) 722/2012 | COMMISSION REGULATION (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin |
2012 | 其他 | EN | |
| MR171 | 2003/32/EC | Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin |
2003 | 其他 | EN | |
| MR172 | (EU) No 207/2012 | COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices |
2012 | 其他 | EN | |
| MR173 | 2011/100/EU | COMMISSION DIRECTIVE 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices |
2011 | 其他 | EN | |
| MR174 | 2002/364/EC | 2002/364/EC: Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices | 2002 | 其他 | EN | |
| MR175 | 2020/0321 (COD) | REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices |
2020 | 其他 | EN | |
| MR176 | (EU) 2019/1396 | COMMISSION IMPLEMENTING DECISION (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices |
2019 | 其他 | EN | |
| MR177 | IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 2020 | 其他 | EN | ||
| MR178 | Ongoing guidance development and other relevant work within MDCG Subgroups – December 2020 | 2020 | 其他 | EN | ||
| MR179 | Guide to Using EUDAMED Actor registration module for economic operator |
2020 | 其他 | EN | ||
| MR180 | EUDAMED - User Rights and Obligations | 2020 | 其他 | EN | ||
| MR181 | DECLARATION ON INFORMATION SECURITY RESPONSIBILITIES IN THE CONTEXT OF THE EUROPEAN MEDICAL DEVICE DATABASE |
2020 | 其他 | EN | ||
| MR182 | EUDAMED-ACTOR MODULE FAQs | 2020 | 其他 | EN | ||
| MR183 | What are the dif_x005f fferent Actor roles in EUDAMED |
2020 | 其他 | EN | ||
| MR184 | ACTOR REGISTRATION REQUEST PROCESS FOR ECONOMIC OPERATORS EXCEPT NON-EU MANUFACTURER |
2020 | 其他 | EN | ||
| MR185 | EUDAMED Mandate Summary document that a non-EU manufacturer should provide in its Actor registration request |
2020 | 其他 | EN | ||
| MR186 | EUDAMED USER ACCESS REQUESTS | 2020 | 其他 | EN | ||
| MR187 | Actor Module - Business Process | 2020 | 其他 | EN | ||
| MR188 | Actor Module - Business Rules | 2020 | 其他 | EN | ||
| MR189 | AIM - Business Process | 2020 | 其他 | EN | ||
| MR190 | AIM - Business Rules | 2020 | 其他 | EN | ||
| MR191 | Ref. Ares(2020)2944220 | Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices | 2020 | 其他 | EN | |
| MR192 | Current performance of COVID-19 test methods and devices and proposed performance criteria |
2020 | 其他 | EN | ||
| MR193 | 2020/C 122 I/01 | COMMUNICATION FROM THE COMMISSION Guidelines on COVID-19 in vitro diagnostic tests and their performance (2020/C 122 I/01) |
2020 | 其他 | EN | |
| MR194 | NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES FOR MEDICINAL PRODUCTS FOR HUMAN USE AND VETERINARY MEDICINAL PRODUCTS |
2020 | 其他 | EN | ||
| MR195 | Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC | 2019 | 其他 | EN | ||
| MR196 | Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU | 2019 | 其他 | EN | ||
| MR197 | Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
2019 | 其他 | EN | ||
| MR198 | Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU |
2019 | 其他 | EN | ||
| MR199 | CAMD Implementation Taskforce Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap |
2017 | 其他 | EN | ||
| MR200 | The safety of medical devices containing DEHPplasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update) |
2015 | 其他 | EN | ||
| MR201 | THE SAFETY OF MEDICAL DEVICES CONTAINING DEHPPLASTICIZED PVC OR OTHER PLASTICIZERS ON NEONATES AND OTHER GROUPS POSSIBLY AT RISK |
2008 | 其他 | EN | ||
| MR202 | REPORT ON NANOTECHNOLOGY TO THE MEDICAL DEVICES EXPERT GROUP FINDINGS AND RECOMMENDATIONS |
2007 | 其他 | EN | ||
| MR203 | Instructions For Use for reusable and re‐sterilisable Medical Devices |
2014 | 其他 | EN | ||
| MR204 | Coronavirus: European standards for medical supplies made freely available to facilitate increase of production | 2020 | 其他 | EN | ||
| MR205 | Coronavirus: Commission issues guidelines on testing | 2020 | 其他 | EN | ||
| MR206 | 2016/425 | REGULATION (EU) 2016/425 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC | 2016 | 其他 | EN | |
| MR207 | 2020/403 | COMMISSION RECOMMENDATION (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat | 2020 | 其他 | EN | |
| MR208 | Factsheet for Manufacturers of medical devices | 2018 | 其他 | EN | ||
| MR209 | Implementation Model for medical devices Regulation Step by Step Guide | 2019 | 其他 | EN | ||
| MR210 | Factsheet for Manufacturers of in vitro diagnostic medical devices | 2018 | 其他 | EN | ||
| MR211 | Implementation Model for in vitro diagnostic medical devices Regulation Step by Step Guide |
2019 | 其他 | EN | ||
| MR212 | Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) |
2020 | 其他 | EN | ||
| MR213 | Factsheet for Authorised Representatives,Importers and Distributors of medical devices and in vitro diagnostic medical devices | 2019 | 其他 | EN | ||
| MR214 | Factsheet for Authorities in non-EU/EEA States on medical devices and in vitro diagnostic medical devices1 | 2019 | 其他 | EN | ||
| MR215 | Factsheet for healthcare professionals and health institutions | 2019 | 其他 | EN | ||
| MR216 | Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices |
2019 | 其他 | EN | ||
| MR217 | 2020/C 171/01 | Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 | 2020 | 其他 | EN | |
| MR218 | List of COVID-19 essential Medical Devices (MDs and IVDs) | 2020 | 其他 | EN | ||
| MR219 | amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions | 2020 | 其他 | EN | ||
| MR220 | New EU rules to ensure safety of medical devices | 2017 | 其他 | EN | ||
| MR221 | Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment | 2021 | 其他 | EN | ||
| MR222 | Transition Timelines from the Directives to the medical devices Regulation | 2019 | 其他 | EN | ||
| MR223 | CLARIFICATION OF “RARE” BLOOD GROUPS AND SUBGROUPS | 2015 | 其他 | EN | ||
| MR224 | European Commission-European Medicines Agency Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future |
2007 | 其他 | EN | ||
| MR225 | INTERPRETATION OF THE RELATION BETWEEN THE REVISED DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 89/686/EEC ON PERSONAL PROTECTIVE EQUIPMENT | 2009 | 其他 | EN | ||
| MR226 | OUTCOME OF THE FIRST PUBLIC CONSULTATION ON THE REPROCESSING OF MEDICAL DEVICES | 2008 | 其他 | EN | ||
| MR227 | WORKSHOP ON REPROCESSING OF MEDICAL DEVICES | 2008 | 其他 | EN | ||
| MR228 | Report on the issue of the reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC | 2010 | 其他 | EN | ||
| MR229 | Transition Timelines from the Directive to the in vitro diagnostic medical devices Regulation |
2019 | 其他 | EN | ||
| MR230 | FAQ – IVDR Transitional provisions | 2018 | 其他 | EN | ||
| MR231 | State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR |
2020 | 其他 | EN | ||
| MR232 | Fact sheet on MDR requirements for Transparency and Public Information | 2020 | 其他 | EN | ||
| MR233 | Impact Assessment of Policy Options for Combating Counterfeiting of Medical Devices and for Developing Safer Distribution Channels for Parallel Trade in Medical Devices | 2015 | 其他 | EN | ||
| MR234 | The European Medical Device Nomenclature (EMDN) | 2020 | 其他 | EN | ||
| MR235 | OVERVIEW OF NBs AT EACH STAGE OF THE PROCESS | 2020 | 其他 | EN | ||
| MR236 | Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746 | 2020 | 其他 | EN | ||
| MR237 | Unique Device Identification (UDI) of Medical Devices | 2013 | 其他 | EN | ||
| MR238 | GS1 AISBL APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs) | 2019 | 其他 | EN | ||
| MR239 | HIBCC APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs) | 2019 | 其他 | EN | ||
| MR240 | ICCBBA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs) | 2019 | 其他 | EN | ||
| MR241 | IFA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs) | 2019 | 其他 | EN | ||
| MR242 | GS1 UDI HRI & AIDC formats | 2019 | 其他 | EN | ||
| MR243 | GS1 General Specifications Change Notification (GSCN) | 2019 | 其他 | EN | ||
| MR244 | HIBCC UDI HRI & AIDC formats | 2019 | 其他 | EN | ||
| MR245 | HIBCC basic UDI-DI | 2019 | 其他 | EN | ||
| MR246 | ICCBBA UDI HRI & AIDC formats | 2019 | 其他 | EN | ||
| MR247 | ISBT 128 STANDARD Coding and Labeling of Medical Devices Containing MPHO | 2019 | 其他 | EN | ||
| MR248 | IFA UDI HRI & AIDC formats | 2019 | 其他 | EN | ||
| MR249 | IFA basic UDI-DI | 2019 | 其他 | EN | ||
| MR250 | GSI Sample UDI Labels UDI Label Examples, HRI & Date Formatting… |
/ | 其他 | EN | ||
| MR251 | GS1 General Specifications | / | 其他 | EN | ||
| MR252 | HIBCC UDI Label Examples | / | 其他 | EN | ||
| MR253 | Technical Information regarding PZN Coding- Check Digit Calculations of PZN, PPN and Basic UDI-DI - | 2019 | 其他 | EN | ||
| MR254 | IFA Coding System Specification Unique Device Identification (UDI) |
2020 | 其他 | EN | ||
| MR255 | IFA Coding System PPN-Code Specification for Retail Packaging | 2020 | 其他 | EN | ||
| MR256 | List of Members Borderline and Classification Medical Devices Expert Group | 2018 | 其他 | EN | ||
| MR257 | MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES |
2019 | 其他 | EN | ||
| MR258 | TERMS OF REFERENCE OF THE MEDICAL DEVICE COORDINATION GROUP | / | 其他 | EN | ||
| MR259 | Medical devices - Regulatory framework | / | 其他 | EN | ||
| MR260 | Management of Conflict of Interests (COI) of experts | / | 其他 | EN | ||
| MR261 | TRoles and tasks of panels and experts:Terms of Reference Rules of Procedure Handling commercially confidential information | / | 其他 | EN | ||
| MR262 | Applying the screening panel decision criteria in the context of the CECP | / | 其他 | EN | ||
| MR263 | Workflow, operations and IT aspects | / | 其他 | EN | ||
| MR264 | 2019/C 323/05 | Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices | 2019 | 其他 | EN | |
| MR265 | Central list of available experts | / | 其他 | EN | ||
| MR266 | Evaluation of the“EUropean DAtabank on MEdical Devices” | 2012 | 其他 | EN | ||
| MR267 | MDR device Basic UDI-DI & UDI-DI attributes Basic UDI-DI set of data in UDI database |
2019 | 其他 | EN | ||
| MR268 | IVDRdevice Basic UDI-DI & UDI-DI attributes Basic UDI-DI set of data in UDI database |
2019 | 其他 | EN | ||
| MR269 | Draft Functional specifications for the European Database on Medical Devices (Eudamed) -First release (High(1)) to be audited | 2019 | 其他 | EN | ||
| MR270 | Guidelines for Member States on the use of Data Exchange solutions MDR EUDAMED |
2019 | 其他 | EN | ||
| MR271 | Eudamed Data Exchange Services and Entity Models Introduction |
2019 | 其他 | EN | ||
| MR272 | Machine-to-Machine (M2M) Data Exchange Services Definition |
2019 | 其他 | EN | ||
| MR273 | MEDDEV 2.7/3 SAE Report Table v2 | 2015 | 其他 | EN | ||
| MR274 | Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 1 | 2001 | 其他 | EN | ||
| MR275 | Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 2 | 2001 | 其他 | EN | ||
| MR276 | Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 3 | 2001 | 其他 | EN | ||
| MR277 | Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 4 | 2001 | 其他 | EN | ||
| MR278 | Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD) |
2020 | 其他 | EN | ||
| MR279 | New manufacturer incident report for importing XML file* with Adobe Professional |
2020 | 其他 | EN | ||
| MR280 | Manufacturer Incidents Report: request for the pa unsecure the MIR form (PDF version) |
2020 | 其他 | EN | ||
| MR281 | New manufacturer incident report XSD file and XSL files | 2020 | 其他 | EN | ||
| MR282 | New manufacturer incident report help text | 2020 | 其他 | EN | ||
| MR283 | Manufacturer Incident Report (MIR) - Changelog | 2019 | 其他 | EN | ||
| MR284 | Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form |
2020 | 其他 | EN | ||
| MR285 | FSCA xml files | 2012 | 其他 | EN | ||
| MR286 | Urgent Field Safety Notice Device Commercial Name |
2018 | 其他 | EN | ||
| MR287 | Template for a Field Safety Notice Customer Reply Form Customer Reply Form |
2018 | 其他 | EN | ||
| MR288 | Template for a Field Safety Notice Distributor/Importer Reply Form Distributor/Importer Reply Form |
2018 | 其他 | EN | ||
| MR289 | Questions and Answers to fill in the Field Safety Notice (FSN). | 2018 | 其他 | EN | ||
| MR290 | Report Form Manufacturer’s Trend Report Medical Devices Vigilance System |
2018 | 其他 | EN | ||
| MR291 | Manufacturer’s Periodic Summary Report (PSR) Medical Devices Vigilance System |
2018 | 其他 | EN | ||
| MR292 | Guidance on the vigilance system for CE-marked medical devices Device Specific Vigilance Guidance Template |
2015 | 其他 | EN | ||
| MR293 | INTERPRETATIVE DOCUMENT OF THE COMMISSION'S SERVICES1 IMPLEMENTATION OF DIRECTIVE 2007/47/EC AMENDING DIRECTIVES 90/385/EEC, 93/42/EEC AND 98/8/EC |
2009 | 其他 | EN | ||
| MR294 | Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10 |
2007 | 其他 | EN | ||
| MR295 | The European Medical Device Nomenclature (EMDN) | 2020 | 其他 | EN | ||
| MR296 | The CND Nomenclature ‘Classificazione Nazionale Dispositivi medici’ | 2020 | 其他 | EN | ||
| MR297 | (EU) 2020/437 | Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC |
2020 | 其他 | EN | |
| MR298 | (EU) 2020/438 | Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC |
2020 | 其他 | EN | |
| MR299 | (EU) 2020/1207 | laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices |
2020 | 其他 | EN | |
| MR300 | (EU) 2017/2185 | Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746 | 2017 | 其他 | EN | |
| MR301 | (EU) 2019/1396 | Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices | 2019 | 其他 | EN | |
| MR302 | (EU) 2019/939 | Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices | 2019 | 其他 | EN | |
| MR303 | / | Conformity assessment procedures for protective equipment | 2020 | 其他 | EN | |
| MR304 | / | Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 |
2021 | 其他 | EN | |
| MR305 | / | Is your software a Medical Device? | 2021 | 其他 | EN | |
| MR306 | MDCG 2021-3 | Questions and Answers on Custom-Made Devices | 2021 | 其他 | EN | |
| MR307 | MDCG 2021-6 | Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | 2021 | 其他 | EN | |
| MR308 | MDCG 2021-5 | Guidance on standardisation for medical devices | 2021 | 指南 | EN | |
| MR309 | MDCG 2018-1 Rev.4 | Guidance on BASIC UDI-DI and changes to UDI-DI | 2021 | 指南 | EN | 下载 |
| MR310 | MDCG 2021-1 Rev.1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | 2021 | 指南 | EN | 下载 |
| MR311 | / | Factsheet for Class I Medical Devices | 2021 | 其他 | EN | 下载 |
| MR312 | MDCG 2021-7 | Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices |
2021 | 其他 | EN | |
| MR313 | MDCG 2021-8 | Clinical investigation application/notification documents | 2021 | 其他 | EN |
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