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MDR CE-法规汇编

编号	法规编号	标题	年份	类别	语言	下载
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	下载
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	下载
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	下载
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	下载
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	下载
MR005	MDD 93/42 / EEC	COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices	1993	法规	EN	下载
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	下载
MR007	MEDDEV 2.1/1	Definitions of 'medical devices', 'accessory' and 'manufacturer	1994	指南	EN	下载
MR008	MEDDEV 2.1/2 rev.2	Field of application of directive 'active implantable medical devices'	1994	指南	EN	下载
MR009	MEDDEV 2.1/2.1	Treatment of computers used to program implantable pulse generators	1998	指南	EN	下载
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	下载
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	下载
MR012	MEDDEV 2.1/5	Medical devices with a measuring function	1998	指南	EN	下载
MR013	MEDDEV 2.1/6	Qualification and classification of stand alone software	2016	指南	EN	下载
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	下载
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	下载
MR016	MEDDEV 2.2/4	Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products	2012	指南	EN	下载
MR017	MEDDEV 2.4/1 rev.9	Classification of medical devices	2010	指南	EN	下载
MR018	MEDDEV 2.5/3 rev.2	Subcontracting quality systems related	1998	指南	EN	下载
MR019	MEDDEV 2.5/5 rev.3	Translation procedure	1998	指南	EN	下载
MR020	MEDDEV 2.5/6 rev.1	Homogenous batches (verification of manufacturers' products)	1998	指南	EN	下载
MR021	MEDDEV 2.5/7 rev.1	Conformity assessment of breast implants	1998	指南	EN	下载
MR022	MEDDEV 2.5/9 rev.1	Evaluation of medical devices incorporating products containing natural rubber latex	2004	指南	EN	下载
MR023	MEDDEV 2.5/10	Guideline for authorised representatives	2012	指南	EN	下载
MR024	MEDDEV 2.7/1 rev.4	Clinical evaluation: Guide for manufacturers and notified bodies	2016	指南	EN	下载
MR025	MEDDEV 2.7/1 Appendix 1	Appendix 1: Clinical evaluation on coronary stents	2008	指南	EN	下载
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	下载
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	下载
MR028	MEDDEV 2.7/4	Guidelines on clinical investigations: a guide for manufacturers and notified bodies	2010	指南	EN	下载
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	下载
MR030	MEDDEV 2.12/1 rev.8	Guidelines on a medical devices vigilance system	2013	指南	EN	下载
MR031	MEDDEV 2.12/1 rev.8	Additional guidance on MEDDEV 2.12/1 rev.8	2019	指南	EN	下载
MR032	MEDDEV 2.12/1 rev 7	Field Safety Corrective Action-FSCA	2012	指南	EN	下载
MR033	DSVG 00	Introduction to device specific vigilance guidance	2014	指南	EN	下载
MR034	DSVG 01	Cardiac ablation vigilance reporting guidance	2016	指南	EN	下载
MR035	DSVG 02	Coronary stents vigilance reporting guidance	2015	指南	EN	下载
MR036	DSVG 03	Cardiac implantable electronic devices (CIED)	2019	指南	EN	下载
MR037	DSVG 04	Breast implants	2019	指南	EN	下载
MR038	MEDDEV 2.12/2 rev.2	Post market clinical follow-up studies	2012	指南	EN	下载
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	下载
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	下载
MR041	MEDDEV 2.14/2 rev.1	Research use only products	2004	指南	EN	下载
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	下载
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	下载
MR044	MEDDEV. 2.15 Rev.3	Committees/working groups contributing to the implementation of the medical device directives December 2008	2008	指南	EN	下载
MR045	MDCG 2020-18	MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers	2020	指南	EN	下载
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	下载
MR047	MDCG 2019-1	MDCG guiding principles for issuing entities rules on basic UDI-DI	2020	指南	EN	下载
MR048	MDCG 2018-7	Provisional considerations regarding language issues associated with the UDI database	2018	指南	EN	下载
MR049	MDCG 2018-6	Clarifications of UDI related responsibilities in relation to article 16	2018	指南	EN	下载
MR050	MDCG 2018-5	UDI assignment to medical device software	2018	指南	EN	下载
MR051	MDCG 2018-4	Definitions/descriptions and formats of the UDI core elements for systems or procedure packs	2018	指南	EN	下载
MR052	MDCG 2018-3 Rev.1	Guidance on UDI for systems and procedure packs	2020	指南	EN	下载
MR053	MDCG 2018-2	Future EU medical device nomenclature - Description of requirements	2018	指南	EN	下载
MR054	MDCG 2018-1 v3	Guidance on basic UDI-DI and changes to UDI-DI	2020	指南	EN	下载
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	下载
MR056	MDCG 2019-5	Registration of legacy devices in EUDAMED	2019	指南	EN	下载
MR057	MDCG 2019-4	Timelines for registration of device data elements in EUDAMED	2019	指南	EN	下载
MR058	MDCG 2021-1	Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional	2021	指南	EN	下载
MR059	MDCG 2020-17	Questions and Answers related to MDCG 2020-4	2020	指南	EN	下载
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	下载
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	下载
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	下载
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	下载
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	下载
MR065	MDCG 2019-14	Explanatory note on MDR codes	2019	指南	EN	下载
MR066	MDCG 2019-13	Guidance on sampling of devices for the assessment of the technical documentation	2019	指南	EN	下载
MR067	MDCG 2019-12	Designating authority's final assessment form: Key information (EN)	2019	指南	EN	下载
MR068	MDCG 2019-10 rev.1	Application of transitional provisions concerning validity of certificates issued in accordance to the directives	2019	指南	EN	下载
MR069	MDCG 2019-6 v2	Questions and answers: Requirements relating to notified bodies	2019	指南	EN	下载
MR070	MDCG 2018-8	Guidance on content of the certificates, voluntary certificate transfers	2018	指南	EN	下载
MR071	NBOG BPG 2017-1	Best practice guidance on designation and notification of conformity assessment bodies	2018	指南	EN	下载
MR072	NBOG BPG 2017-2	Best practice guidance on the information required for personnel involved in conformity assessment	2018	指南	EN	下载
MR073	NBOG F 2017-8	Review of qualification for the authorisation of personnel(IVDR)	2018	指南	EN	下载
MR074	NBOG F 2017-7	Review of qualification for the authorisation of personnel (MDR)	2018	指南	EN	下载
MR075	NBOG F 2017-6	Preliminary assessment review template (IVDR)	2018	指南	EN	下载
MR076	NBOG F 2017-5	Preliminary assessment review template (MDR)	2018	指南	EN	下载
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	下载
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	下载
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	下载
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	下载
MR081	MDCG2020-13	Clinical evaluation assessment report template	2020	指南	EN	下载
MR082	MDCG 2020-10/1	Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form	2020	指南	EN	下载
MR083	MDCG 2020-10/2	Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form	2020	指南	EN	下载
MR084	MDCG 2020-8	Guidance on PMCF evaluation report templateC	2020	指南	EN	下载
MR085	MDCG 2020-7	Guidance on PMCF plan template	2020	指南	EN	下载
MR086	MDCG 2020-6	Guidance on sufficient clinical evidence for legacy devices	2020	指南	EN	下载
MR087	MDCG 2020-5	Guidance on clinical evaluation – Equivalence	2020	指南	EN	下载
MR088	MDCG 2019-9	Summary of safety and clinical performance	2019	指南	EN	下载
MR089	MDCG 2020-1	Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software	2020	指南	EN	下载
MR090	MDCG 2019-16 rev.1	Guidance on cybersecurity for medical devices	2019	指南	EN	下载
MR091	MDCG 2019-11	Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746	2019	指南	EN	下载
MR092	MDCG 2020-16	Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746	2020	指南	EN	下载
MR093	MDCG 2020-9	Regulatory requirements for ventilators and related accessories	2020	指南	EN	下载
MR094	MDCG 2020-2 rev.1	Class I transitional provisions under Article 120 (3 and 4) – (MDR)	2020	指南	EN	下载
MR095	MDCG 2019-15 rev.1	Guidance notes for manufacturers of class I medical devices	2019	指南	EN	下载
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	下载
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	下载
MR098	MDCG 2019-3 rev.1	Interpretation of article 54(2)b	2020	指南	EN	下载
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	下载
MR100		Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context	2020	指南	EN	下载
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	下载
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	下载
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	下载
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	下载
MR105		Guidance Notes for Manufacturers of Custom-Made Medical Devices	2010	指南	EN	下载
MR106		Guidance document on Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements	2006	指南	EN	下载
MR107		GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES	2009	指南	EN	下载
MR108	Recommendation-NB-MED-2_7-1_rev2	Recommendation-NB-MED-2_7-1_rev2 Guidance on clinicals	1998	指南	EN	下载
MR109		CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions	2018	其他	EN	下载
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	下载
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	下载
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	下载
MR113	NBM-003-19	Joint NB-Position Paper on Spinal Classification per the MDR	2018	其他	EN	下载
MR114	NBM-046-18	One Year of Application	2018	其他	EN	下载
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	下载
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	下载
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	下载
MR118	NB-MED/2.5.1/Rec5	Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation	2000	其他	EN	下载
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	下载
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	下载
MR121	NB-MED/2.13/Rec1	Recommendation-NB-MED-2_13-1_rev3 CE-Marking of pre-MDD devices	1998	其他	EN	下载
MR122	NB-MED/2.12/Rec1	Recommendation-NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS)	2000	其他	EN	下载
MR123	Recommendation-NB-MED-2_7-3_rev5	Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data	1999	其他	EN	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
MR130	NB-MED-2_5_4-1_rev4	Recommendation-NB-MED-2_5_4-1_rev4 Homogeneous batches	2000	其他	EN	下载
MR131	NB-MED-2_5_2-3_rev9	Recommendation-NB-MED-2_5_2-3_rev9 Translation procedure	2000	其他	EN	下载
MR132	NB-MED-2_5_2-1_rev4	Recommendation-NB-MED-2_5_2-1_rev4 Subcontracting – QS related	2000	其他	EN	下载
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	下载
MR134	NB-MED-2_5_1-4_rev4	Recommendation-NB-MED-2_5_1-4_rev4 Content of mandatory certificates	1998	其他	EN	下载
MR135	NB-MED-2_2 Rec1	Recommendation-NB-MED-2_2 Rec1 EMC requirements	1998	其他	EN	下载
MR136	NB-MED-2_2-4_rev5	Recommendation-NB-MED-2_2-4_rev5 Software and Medical Devices	2001	其他	EN	下载
MR137	NB-MED/2.2/Rec3	Recommendation-NB-MED-2_2-3_rev4 ‘Use-by’ date for Medical Devices	2000	其他	EN	下载
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	下载
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	下载
MR140	NB-MED-2_1-4_rev7	Recommendation-NB-MED-2_1-4_rev7 Medical devices with a measuring function	1998	其他	EN	下载
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	下载
MR142	NB-MED-2_1-2_rev5	Recommendation-NB-MED-2_1-2_rev5 Explanation of Terms	1998	其他	EN	下载
MR143	NB-MED-2_1-1_rev4	Recommendation-NB-MED-2_1-1_rev4 Representative Sample	2000	其他	EN	下载
MR144	NB-Med_2007-04	Recommendation_Vigilance_after NB-Med_2007-04	2007	其他	EN	下载
MR145		NB-MED letter to MS on 2007_47 implementation	2009	其他	EN	下载
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	下载
MR147		Insulin Infusion Pumps and Integrated meter systems	2020	其他	EN	下载
MR148		Instructions for use for reusable & re-sterilisable medical devices) e	2020	其他	EN	下载
MR149		Requirements for in vitro diagnostic kits measuring parameters which can be used for evaluating the risk of trisomy 21	2006	其他	EN	下载
MR150		Informative document of the Commission’s services on placing on the market of medical devices	2010	其他	EN	下载
MR151		Information on the Customs Union Agreement with Turkey in the field of medical devices	2010	其他	EN	下载
MR152		DECISION No 1/2006 OF THE EC-TURKEY ASSOCIATION COUNCIL of 15 May 2006	2006	其他	EN	下载
MR153		Statement of Turkey – EC Customs Union Joint Committee on the implementation of Article 1 of Decision 1/2006	2006	其他	EN	下载
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	下载
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	下载
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	下载
MR157		Information on the Medical Devices Directives in relation to medical device own brand labellers	2015	其他	EN	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
MR169		COMMISSION DECISION of 19 April 2010 on the European Databank on Medical Devices (Eudamed)	2010	其他	EN	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
MR177		IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746	2020	其他	EN	下载
MR178		Ongoing guidance development and other relevant work within MDCG Subgroups – December 2020	2020	其他	EN	下载
MR179		Guide to Using EUDAMED Actor registration module for economic operator	2020	其他	EN	下载
MR180		EUDAMED - User Rights and Obligations	2020	其他	EN	下载
MR181		DECLARATION ON INFORMATION SECURITY RESPONSIBILITIES IN THE CONTEXT OF THE EUROPEAN MEDICAL DEVICE DATABASE	2020	其他	EN	下载
MR182		EUDAMED-ACTOR MODULE FAQs	2020	其他	EN	下载
MR183		What are the dif_x005ffferent Actor roles in EUDAMED	2020	其他	EN	下载
MR184		ACTOR REGISTRATION REQUEST PROCESS FOR ECONOMIC OPERATORS EXCEPT NON-EU MANUFACTURER	2020	其他	EN	下载
MR185		EUDAMED Mandate Summary document that a non-EU manufacturer should provide in its Actor registration request	2020	其他	EN	下载
MR186		EUDAMED USER ACCESS REQUESTS	2020	其他	EN	下载
MR187		Actor Module - Business Process	2020	其他	EN	下载
MR188		Actor Module - Business Rules	2020	其他	EN	下载
MR189		AIM - Business Process	2020	其他	EN	下载
MR190		AIM - Business Rules	2020	其他	EN	下载
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	下载
MR192		Current performance of COVID-19 test methods and devices and proposed performance criteria	2020	其他	EN	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
MR199		CAMD Implementation Taskforce Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap	2017	其他	EN	下载
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	下载
MR201		THE SAFETY OF MEDICAL DEVICES CONTAINING DEHPPLASTICIZED PVC OR OTHER PLASTICIZERS ON NEONATES AND OTHER GROUPS POSSIBLY AT RISK	2008	其他	EN	下载
MR202		REPORT ON NANOTECHNOLOGY TO THE MEDICAL DEVICES EXPERT GROUP FINDINGS AND RECOMMENDATIONS	2007	其他	EN	下载
MR203		Instructions For Use for reusable and re‐sterilisable Medical Devices	2014	其他	EN	下载
MR204		Coronavirus: European standards for medical supplies made freely available to facilitate increase of production	2020	其他	EN	下载
MR205		Coronavirus: Commission issues guidelines on testing	2020	其他	EN	下载
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	下载
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	下载
MR208		Factsheet for Manufacturers of medical devices	2018	其他	EN	下载
MR209		Implementation Model for medical devices Regulation Step by Step Guide	2019	其他	EN	下载
MR210		Factsheet for Manufacturers of in vitro diagnostic medical devices	2018	其他	EN	下载
MR211		Implementation Model for in vitro diagnostic medical devices Regulation Step by Step Guide	2019	其他	EN	下载
MR212		Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)	2020	其他	EN	下载
MR213		Factsheet for Authorised Representatives,Importers and Distributors of medical devices and in vitro diagnostic medical devices	2019	其他	EN	下载
MR214		Factsheet for Authorities in non-EU/EEA States on medical devices and in vitro diagnostic medical devices1	2019	其他	EN	下载
MR215		Factsheet for healthcare professionals and health institutions	2019	其他	EN	下载
MR216		Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices	2019	其他	EN	下载
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	下载
MR218		List of COVID-19 essential Medical Devices (MDs and IVDs)	2020	其他	EN	下载
MR219		amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions	2020	其他	EN	下载
MR220		New EU rules to ensure safety of medical devices	2017	其他	EN	下载
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	下载
MR222		Transition Timelines from the Directives to the medical devices Regulation	2019	其他	EN	下载
MR223		CLARIFICATION OF “RARE” BLOOD GROUPS AND SUBGROUPS	2015	其他	EN	下载
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	下载
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	下载
MR226		OUTCOME OF THE FIRST PUBLIC CONSULTATION ON THE REPROCESSING OF MEDICAL DEVICES	2008	其他	EN	下载
MR227		WORKSHOP ON REPROCESSING OF MEDICAL DEVICES	2008	其他	EN	下载
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	下载
MR229		Transition Timelines from the Directive to the in vitro diagnostic medical devices Regulation	2019	其他	EN	下载
MR230		FAQ – IVDR Transitional provisions	2018	其他	EN	下载
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	下载
MR232		Fact sheet on MDR requirements for Transparency and Public Information	2020	其他	EN	下载
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	下载
MR234		The European Medical Device Nomenclature (EMDN)	2020	其他	EN	下载
MR235		OVERVIEW OF NBs AT EACH STAGE OF THE PROCESS	2020	其他	EN	下载
MR236		Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746	2020	其他	EN	下载
MR237		Unique Device Identification (UDI) of Medical Devices	2013	其他	EN	下载
MR238		GS1 AISBL APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
MR239		HIBCC APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
MR240		ICCBBA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
MR241		IFA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
MR242		GS1 UDI HRI & AIDC formats	2019	其他	EN	下载
MR243		GS1 General Specifications Change Notification (GSCN)	2019	其他	EN	下载
MR244		HIBCC UDI HRI & AIDC formats	2019	其他	EN	下载
MR245		HIBCC basic UDI-DI	2019	其他	EN	下载
MR246		ICCBBA UDI HRI & AIDC formats	2019	其他	EN	下载
MR247		ISBT 128 STANDARD Coding and Labeling of Medical Devices Containing MPHO	2019	其他	EN	下载
MR248		IFA UDI HRI & AIDC formats	2019	其他	EN	下载
MR249		IFA basic UDI-DI	2019	其他	EN	下载
MR250		GSI Sample UDI Labels UDI Label Examples, HRI & Date Formatting…	/	其他	EN	下载
MR251		GS1 General Specifications	/	其他	EN	下载
MR252		HIBCC UDI Label Examples	/	其他	EN	下载
MR253		Technical Information regarding PZN Coding- Check Digit Calculations of PZN, PPN and Basic UDI-DI -	2019	其他	EN	下载
MR254		IFA Coding System Specification Unique Device Identification (UDI)	2020	其他	EN	下载
MR255		IFA Coding System PPN-Code Specification for Retail Packaging	2020	其他	EN	下载
MR256		List of Members Borderline and Classification Medical Devices Expert Group	2018	其他	EN	下载
MR257		MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES	2019	其他	EN	下载
MR258		TERMS OF REFERENCE OF THE MEDICAL DEVICE COORDINATION GROUP	/	其他	EN	下载
MR259		Medical devices - Regulatory framework	/	其他	EN	下载
MR260		Management of Conflict of Interests (COI) of experts	/	其他	EN	下载
MR261		TRoles and tasks of panels and experts:Terms of Reference Rules of Procedure Handling commercially confidential information	/	其他	EN	下载
MR262		Applying the screening panel decision criteria in the context of the CECP	/	其他	EN	下载
MR263		Workflow, operations and IT aspects	/	其他	EN	下载
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	下载
MR265		Central list of available experts	/	其他	EN	下载
MR266		Evaluation of the“EUropean DAtabank on MEdical Devices”	2012	其他	EN	下载
MR267		MDR device Basic UDI-DI & UDI-DI attributes Basic UDI-DI set of data in UDI database	2019	其他	EN	下载
MR268		IVDRdevice Basic UDI-DI & UDI-DI attributes Basic UDI-DI set of data in UDI database	2019	其他	EN	下载
MR269		Draft Functional specifications for the European Database on Medical Devices (Eudamed) -First release (High(1)) to be audited	2019	其他	EN	下载
MR270		Guidelines for Member States on the use of Data Exchange solutions MDR EUDAMED	2019	其他	EN	下载
MR271		Eudamed Data Exchange Services and Entity Models Introduction	2019	其他	EN	下载
MR272		Machine-to-Machine (M2M) Data Exchange Services Definition	2019	其他	EN	下载
MR273		MEDDEV 2.7/3 SAE Report Table v2	2015	其他	EN	下载
MR274		Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 1	2001	其他	EN	下载
MR275		Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 2	2001	其他	EN	下载
MR276		Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 3	2001	其他	EN	下载
MR277		Designation and monitoring of notified bodies within the framework of EC directives on medical devices Annex 4	2001	其他	EN	下载
MR278		Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)	2020	其他	EN	下载
MR279		New manufacturer incident report for importing XML file* with Adobe Professional	2020	其他	EN	下载
MR280		Manufacturer Incidents Report: request for the pa unsecure the MIR form (PDF version)	2020	其他	EN	下载
MR281		New manufacturer incident report XSD file and XSL files	2020	其他	EN	下载
MR282		New manufacturer incident report help text	2020	其他	EN	下载
MR283		Manufacturer Incident Report (MIR) - Changelog	2019	其他	EN	下载
MR284		Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form	2020	其他	EN	下载
MR285		FSCA xml files	2012	其他	EN	下载
MR286		Urgent Field Safety Notice Device Commercial Name	2018	其他	EN	下载
MR287		Template for a Field Safety Notice Customer Reply Form Customer Reply Form	2018	其他	EN	下载
MR288		Template for a Field Safety Notice Distributor/Importer Reply Form Distributor/Importer Reply Form	2018	其他	EN	下载
MR289		Questions and Answers to fill in the Field Safety Notice (FSN).	2018	其他	EN	下载
MR290		Report Form Manufacturer’s Trend Report Medical Devices Vigilance System	2018	其他	EN	下载
MR291		Manufacturer’s Periodic Summary Report (PSR) Medical Devices Vigilance System	2018	其他	EN	下载
MR292		Guidance on the vigilance system for CE-marked medical devices Device Specific Vigilance Guidance Template	2015	其他	EN	下载
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	下载
MR294		Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10	2007	其他	EN	下载
MR295		The European Medical Device Nomenclature (EMDN)	2020	其他	EN	下载
MR296		The CND Nomenclature ‘Classificazione Nazionale Dispositivi medici’	2020	其他	EN	下载
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	下载
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	下载
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	下载
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	下载
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	下载
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	下载
MR303		Conformity assessment procedures for protective equipment	2020	其他	EN	下载
MR304		Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19	2021	其他	EN	下载
MR305	/	Is your software a Medical Device?	2021	其他	EN	下载
MR306	MDCG 2021-3	Questions and Answers on Custom-Made Devices	2021	其他	EN	下载

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