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IVDR CE-法规汇编

编号	法规编号	标题	年份	类别	语言	下载
IR001	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
IR002	/	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	法规	EN	下载
IR003	/	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	法规	EN	下载
IR004	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
IR005	MEDDEV 2.1/1	Definitions of 'medical devices', 'accessory' and 'manufacturer	1994	指南	EN	下载
IR006	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
IR007	MEDDEV 2.1/5	Medical devices with a measuring function	1998	指南	EN	下载
IR008	MEDDEV 2.1/6	Qualification and classification of stand alone software	2016	指南	EN	下载
IR009	MEDDEV 2.5/3 rev.2	Subcontracting quality systems related	1998	指南	EN	下载
IR010	MEDDEV 2.5/5 rev.3	Translation procedure	1998	指南	EN	下载
IR011	MEDDEV 2.5/6 rev.1	Homogenous batches (verification of manufacturers' products)	1998	指南	EN	下载
IR012	MEDDEV 2.5/10	Guideline for authorised representatives	2012	指南	EN	下载
IR013	MEDDEV 2.7/4	Guidelines on clinical investigations: a guide for manufacturers and notified bodies	2010	指南	EN	下载
IR014	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
IR015	MEDDEV 2.12/1 rev.8	Guidelines on a medical devices vigilance system	2013	指南	EN	下载
IR016	MEDDEV 2.12/1 rev.8	Additional guidance on MEDDEV 2.12/1 rev.8	2019	指南	EN	下载
IR017	MEDDEV 2.12/1 rev 7	Field Safety Corrective Action-FSCA	2012	指南	EN	下载
IR018	DSVG 00	Introduction to device specific vigilance guidance	2014	指南	EN	下载
IR019	MEDDEV 2.12/2 rev.2	Post market clinical follow-up studies	2012	指南	EN	下载
IR020	MEDDEV 2.13 rev.1	Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05)	1998	指南	EN	下载
IR021	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
IR022	MEDDEV 2.14/2 rev.1	Research use only products	2004	指南	EN	下载
IR023	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
IR024	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
IR025	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
IR026	MDCG 2019-1	MDCG guiding principles for issuing entities rules on basic UDI-DI	2020	指南	EN	下载
IR027	MDCG 2018-7	Provisional considerations regarding language issues associated with the UDI database	2018	指南	EN	下载
IR028	MDCG 2018-6	Clarifications of UDI related responsibilities in relation to article 16	2018	指南	EN	下载
IR029	MDCG 2018-5	UDI assignment to medical device software	2018	指南	EN	下载
IR030	MDCG 2018-4	Definitions/descriptions and formats of the UDI core elements for systems or procedure packs	2018	指南	EN	下载
IR031	MDCG 2018-3 Rev.1	Guidance on UDI for systems and procedure packs	2020	指南	EN	下载
IR032	MDCG 2018-2	Future EU medical device nomenclature - Description of requirements	2018	指南	EN	下载
IR033	MDCG 2018-1 v3	Guidance on basic UDI-DI and changes to UDI-DI	2020	指南	EN	下载
IR034	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
IR035	MDCG 2019-5	Registration of legacy devices in EUDAMED	2019	指南	EN	下载
IR036	MDCG 2019-4	Timelines for registration of device data elements in EUDAMED	2019	指南	EN	下载
IR037	MDCG 2021-1	Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional	2021	指南	EN	下载
IR038	MDCG 2020-17	Questions and Answers related to MDCG 2020-4	2020	指南	EN	下载
IR039	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
IR040	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
IR041	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
IR042	MDCG 2019-13	Guidance on sampling of devices for the assessment of the technical documentation	2019	指南	EN	下载
IR043	MDCG 2019-12	Designating authority's final assessment form: Key information (EN)	2019	指南	EN	下载
IR044	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
IR045	MDCG 2019-6 v2	Questions and answers: Requirements relating to notified bodies	2019	指南	EN	下载
IR046	MDCG 2018-8	Guidance on content of the certificates, voluntary certificate transfers	2018	指南	EN	下载
IR047	NBOG BPG 2017-1	Best practice guidance on designation and notification of conformity assessment bodies	2018	指南	EN	下载
IR048	NBOG BPG 2017-2	Best practice guidance on the information required for personnel involved in conformity assessment	2018	指南	EN	下载
IR049	NBOG F 2017-8	Review of qualification for the authorisation of personnel(IVDR)	2018	指南	EN	下载
IR050	NBOG F 2017-6	Preliminary assessment review template (IVDR)	2018	指南	EN	下载
IR051	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
IR052	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
IR053	MDCG 2020-10/1	Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form	2020	指南	EN	下载
IR054	MDCG 2020-10/2	Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form	2020	指南	EN	下载
IR055	MDCG 2020-8	Guidance on PMCF evaluation report templateC	2020	指南	EN	下载
IR056	MDCG 2020-7	Guidance on PMCF plan template	2020	指南	EN	下载
IR057	MDCG 2020-6	Guidance on sufficient clinical evidence for legacy devices	2020	指南	EN	下载
IR058	MDCG 2019-9	Summary of safety and clinical performance	2019	指南	EN	下载
IR059	MDCG 2019-16 rev.1	Guidance on cybersecurity for medical devices	2019	指南	EN	下载
IR060	MDCG 2019-11	Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746	2019	指南	EN	下载
IR061	MDCG 2020-16	Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746	2020	指南	EN	下载
IR062	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
IR063	MDCG 2019-3 rev.1	Interpretation of article 54(2)b	2020	指南	EN	下载
IR064	/	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
IR065	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
IR066	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
IR067	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
IR068	Recommendation-NB-MED-2_7-1_rev2	Recommendation-NB-MED-2_7-1_rev2 Guidance on clinicals	1998	指南	EN	下载
IR069	MDCG 2021-2	Guidance on state of the art of COVID-19 rapid antibody tests March 2021	2021	指南	EN	下载
IR070	/	CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions	2018	其他	EN	下载
IR071	NBM-046-18	One Year of Application	2018	其他	EN	下载
IR072	/	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
IR073	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
IR074	NB-MED/2.5.1/Rec5	Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation	2000	其他	EN	下载
IR075	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
IR076	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
IR077	NB-MED/2.12/Rec1	Recommendation-NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS)	2000	其他	EN	下载
IR078	Recommendation-NB-MED-2_7-3_rev5	Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data	1999	其他	EN	下载
IR079	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
IR080	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
IR081	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
IR082	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
IR083	NB-MED-2_5_4-1_rev4	Recommendation-NB-MED-2_5_4-1_rev4 Homogeneous batches	2000	其他	EN	下载
IR084	NB-MED-2_5_2-3_rev9	Recommendation-NB-MED-2_5_2-3_rev9 Translation procedure	2000	其他	EN	下载
IR085	NB-MED-2_5_2-1_rev4	Recommendation-NB-MED-2_5_2-1_rev4 Subcontracting – QS related	2000	其他	EN	下载
IR086	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
IR087	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
IR088	NB-MED-2_2 Rec1	Recommendation-NB-MED-2_2 Rec1 EMC requirements	1998	其他	EN	下载
IR089	NB-MED/2.2/Rec3	Recommendation-NB-MED-2_2-3_rev4 ‘Use-by’ date for Medical Devices	2000	其他	EN	下载
IR090	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
IR091	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
IR092	NB-MED-2_1-2_rev5	Recommendation-NB-MED-2_1-2_rev5 Explanation of Terms	1998	其他	EN	下载
IR093	NB-MED-2_1-1_rev4	Recommendation-NB-MED-2_1-1_rev4 Representative Sample	2000	其他	EN	下载
IR094	NB-Med_2007-04	Recommendation_Vigilance_after NB-Med_2007-04	2007	其他	EN	下载
IR095	/	NB-MED letter to MS on 2007_47 implementation	2009	其他	EN	下载
IR096	/	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
IR097	/	Informative document of the Commission’s services on placing on the market of medical devices	2010	其他	EN	下载
IR098	/	Information on the Customs Union Agreement with Turkey in the field of medical devices	2010	其他	EN	下载
IR099	/	DECISION No 1/2006 OF THE EC-TURKEY ASSOCIATION COUNCIL of 15 May 2006	2006	其他	EN	下载
IR100	/	Statement of Turkey – EC Customs Union Joint Committee on the implementation of Article 1 of Decision 1/2006	2006	其他	EN	下载
IR101	/	Information on the Medical Devices Directives in relation to medical device own brand labellers	2015	其他	EN	下载
IR102	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
IR103	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
IR104	(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
IR105	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
IR106	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
IR107	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
IR108	2002/364/EC	COMMISSION DECISION 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
IR109	/	COMMISSION DECISION of 19 April 2010 on the European Databank on Medical Devices (Eudamed)	2010	其他	EN	下载
IR110	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
IR111	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
IR112	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
IR113	/	IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746	2020	其他	EN	下载
IR114	/	Ongoing guidance development and other relevant work within MDCG Subgroups – December 2020	2020	其他	EN	下载
IR115	/	Guide to Using EUDAMED Actor registration module for economic operator	2020	其他	EN	下载
IR116	/	EUDAMED - User Rights and Obligations	2020	其他	EN	下载
IR117	/	DECLARATION ON INFORMATION SECURITY RESPONSIBILITIES IN THE CONTEXT OF THE EUROPEAN MEDICAL DEVICE DATABASE	2020	其他	EN	下载
IR118	/	EUDAMED-ACTOR MODULE FAQs	2020	其他	EN	下载
IR119	/	What are the dif_x005ffferent Actor roles in EUDAMED	2020	其他	EN	下载
IR120	/	ACTOR REGISTRATION REQUEST PROCESS FOR ECONOMIC OPERATORS EXCEPT NON-EU MANUFACTURER	2020	其他	EN	下载
IR121	/	EUDAMED Mandate Summary document that a non-EU manufacturer should provide in its Actor registration request	2020	其他	EN	下载
IR122	/	EUDAMED USER ACCESS REQUESTS	2020	其他	EN	下载
IR123	/	Actor Module - Business Process	2020	其他	EN	下载
IR124	/	Actor Module - Business Rules	2020	其他	EN	下载
IR125	/	AIM - Business Process	2020	其他	EN	下载
IR126	/	AIM - Business Rules	2020	其他	EN	下载
IR127	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
IR128	/	Current performance of COVID-19 test methods and devices and proposed performance criteria	2020	其他	EN	下载
IR129	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
IR130	/	CAMD Implementation Taskforce Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap	2017	其他	EN	下载
IR131	/	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
IR132	/	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
IR133	/	REPORT ON NANOTECHNOLOGY TO THE MEDICAL DEVICES EXPERT GROUP FINDINGS AND RECOMMENDATIONS	2007	其他	EN	下载
IR134	/	Coronavirus: European standards for medical supplies made freely available to facilitate increase of production	2020	其他	EN	下载
IR135	/	Coronavirus: Commission issues guidelines on testing	2020	其他	EN	下载
IR136	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
IR137	/	Implementation Model for medical devices Regulation Step by Step Guide	2019	其他	EN	下载
IR138	/	Implementation Model for in vitro diagnostic medical devices Regulation Step by Step Guide	2019	其他	EN	下载
IR139	/	Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)	2020	其他	EN	下载
IR140	/	Factsheet for Authorised Representatives,Importers and Distributors of medical devices and in vitro diagnostic medical devices	2019	其他	EN	下载
IR141	/	Factsheet for Authorities in non-EU/EEA States on medical devices and in vitro diagnostic medical devices1	2019	其他	EN	下载
IR142	/	Factsheet for healthcare professionals and health institutions	2019	其他	EN	下载
IR143	/	Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices	2019	其他	EN	下载
IR144	/	List of COVID-19 essential Medical Devices (MDs and IVDs)	2020	其他	EN	下载
IR145	/	New EU rules to ensure safety of medical devices	2017	其他	EN	下载
IR146	/	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
IR147	/	CLARIFICATION OF “RARE” BLOOD GROUPS AND SUBGROUPS	2015	其他	EN	下载
IR148	/	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
IR149	/	Transition Timelines from the Directive to the in vitro diagnostic medical devices Regulation	2019	其他	EN	下载
IR150	/	FAQ – IVDR Transitional provisions	2018	其他	EN	下载
IR151	/	The European Medical Device Nomenclature (EMDN)	2020	其他	EN	下载
IR152	/	OVERVIEW OF NBs AT EACH STAGE OF THE PROCESS	2020	其他	EN	下载
IR153	/	Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746	2020	其他	EN	下载
IR154	/	Unique Device Identification (UDI) of Medical Devices	2013	其他	EN	下载
IR155	/	GS1 AISBL APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
IR156	/	HIBCC APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
IR157	/	ICCBBA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
IR158	/	IFA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)	2019	其他	EN	下载
IR159	/	GS1 UDI HRI & AIDC formats	2019	其他	EN	下载
IR160	/	GS1 General Specifications Change Notification (GSCN)	2019	其他	EN	下载
IR161	/	HIBCC UDI HRI & AIDC formats	2019	其他	EN	下载
IR162	/	HIBCC basic UDI-DI	2019	其他	EN	下载
IR163	/	ICCBBA UDI HRI & AIDC formats	2019	其他	EN	下载
IR164	/	ISBT 128 STANDARD Coding and Labeling of Medical Devices Containing MPHO	2019	其他	EN	下载
IR165	/	IFA UDI HRI & AIDC formats	2019	其他	EN	下载
IR166	/	IFA basic UDI-DI	2019	其他	EN	下载
IR167	/	GSI Sample UDI Labels UDI Label Examples, HRI & Date Formatting…	/	其他	EN	下载
IR168	/	GS1 General Specifications	/	其他	EN	下载
IR169	/	HIBCC UDI Label Examples	/	其他	EN	下载
IR170	/	Technical Information regarding PZN Coding- Check Digit Calculations of PZN, PPN and Basic UDI-DI -	2019	其他	EN	下载
IR171	/	IFA Coding System Specification Unique Device Identification (UDI)	2020	其他	EN	下载
IR172	/	IFA Coding System PPN-Code Specification for Retail Packaging	2020	其他	EN	下载
IR173	/	List of Members Borderline and Classification Medical Devices Expert Group	2018	其他	EN	下载
IR174	/	TERMS OF REFERENCE OF THE MEDICAL DEVICE COORDINATION GROUP	/	其他	EN	下载
IR175	/	Medical devices - Regulatory framework	/	其他	EN	下载
IR176	/	Management of Conflict of Interests (COI) of experts	/	其他	EN	下载
IR177	/	TRoles and tasks of panels and experts:Terms of Reference Rules of Procedure Handling commercially confidential information	/	其他	EN	下载
IR178	/	Applying the screening panel decision criteria in the context of the CECP	/	其他	EN	下载
IR179	/	Workflow, operations and IT aspects	/	其他	EN	下载
IR180	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
IR181	/	Central list of available experts	/	其他	EN	下载
IR182	/	Evaluation of the“EUropean DAtabank on MEdical Devices”	2012	其他	EN	下载
IR183	/	IVDRdevice Basic UDI-DI & UDI-DI attributes Basic UDI-DI set of data in UDI database	2019	其他	EN	下载
IR184	/	Draft Functional specifications for the European Database on Medical Devices (Eudamed) -First release (High(1)) to be audited	2019	其他	EN	下载
IR185	/	Guidelines for Member States on the use of Data Exchange solutions MDR EUDAMED	2019	其他	EN	下载
IR186	/	Eudamed Data Exchange Services and Entity Models Introduction	2019	其他	EN	下载
IR187	/	Machine-to-Machine (M2M) Data Exchange Services Definition	2019	其他	EN	下载
IR188	/	MEDDEV 2.7/3 SAE Report Table v2	2015	其他	EN	下载
IR189	/	Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (AIMDD/MDD/IVDD)	2020	其他	EN	下载
IR190	/	New manufacturer incident report for importing XML file* with Adobe Professional	2020	其他	EN	下载
IR191	/	Manufacturer Incidents Report: request for the pa unsecure the MIR form (PDF version)	2020	其他	EN	下载
IR192	/	New manufacturer incident report XSD file and XSL files	2020	其他	EN	下载
IR193	/	New manufacturer incident report help text	2020	其他	EN	下载
IR194	/	Manufacturer Incident Report (MIR) - Changelog	2019	其他	EN	下载
IR195	/	Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form	2020	其他	EN	下载
IR196	/	FSCA xml files	2012	其他	EN	下载
IR197	/	Urgent Field Safety Notice Device Commercial Name	2018	其他	EN	下载
IR198	/	Template for a Field Safety Notice Customer Reply Form Customer Reply Form	2018	其他	EN	下载
IR199	/	Template for a Field Safety Notice Distributor/Importer Reply Form Distributor/Importer Reply Form	2018	其他	EN	下载
IR200	/	Questions and Answers to fill in the Field Safety Notice (FSN).	2018	其他	EN	下载
IR201	/	Report Form Manufacturer’s Trend Report Medical Devices Vigilance System	2018	其他	EN	下载
IR202	/	Manufacturer’s Periodic Summary Report (PSR) Medical Devices Vigilance System	2018	其他	EN	下载
IR203	/	Guidance on the vigilance system for CE-marked medical devices Device Specific Vigilance Guidance Template	2015	其他	EN	下载
IR204	/	Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10	2007	其他	EN	下载
IR205	/	The European Medical Device Nomenclature (EMDN)	2020	其他	EN	下载
IR206	/	The CND Nomenclature ‘Classificazione Nazionale Dispositivi medici’	2020	其他	EN	下载
IR207	(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
IR208	(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
IR209	/	Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19	2021	其他	EN	下载

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