MDR法规和指南最新清单汇总
本帖最后由 RA小编辑 于 2021-3-26 15:55 编辑1. MDR法规清单
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MR001 MDR 2017/745 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下载
MR003 2020/561 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions下载
MR004 IVDD 98/79/EC DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILon in vitro diagnostic medical devices下载
MR005 MDD 93/42 / EEC COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices下载
MR006 AIMD90/385/EECCOUNCIL DIRECTIVE of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)下载
2. MDR指南清单
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MR007 MEDDEV 2.1/1 Definitions of 'medical devices', 'accessory' and 'manufacturer下载
MR008 MEDDEV 2.1/2 rev.2 Field of application of directive 'activeimplantable medical devices'下载
MR009 MEDDEV 2.1/2.1Treatment of computers used to programimplantable pulse generators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下载
MR012 MEDDEV 2.1/5 Medical devices with a measuring function下载
MR013 MEDDEV 2.1/6Qualification and classification of stand alone software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 DEVICESTHE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES-USE-by-date下载
MR016 MEDDEV 2.2/4Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products下载
MR017 MEDDEV 2.4/1 rev.9 Classification of medical devices下载
MR018 MEDDEV 2.5/3 rev.2Subcontracting quality systems related下载
MR019 MEDDEV 2.5/5 rev.3Translation procedure下载
MR020 MEDDEV 2.5/6 rev.1Homogenous batches (verification of manufacturers' products)下载
MR021 MEDDEV 2.5/7 rev.1Conformity assessment of breast implants下载
MR022 MEDDEV 2.5/9 rev.1Evaluation of medical devices incorporating products containing natural rubber latex下载
MR023 MEDDEV 2.5/10 Guideline for authorised representatives下载
MR024 MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies下载
MR025 MEDDEV 2.7/1Appendix 1 Appendix 1: Clinical evaluation on coronary stents下载
MR026 MEDDEV 2.7/2 rev.2Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC and 93/42/EC下载
MR027 MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC下载
MR028 MEDDEV 2.7/4Guidelines on clinical investigations: a guide for manufacturers and notified bodies下载
MR029 MEDDEV 2.10/2 rev.1 Designation and monitoring of notified bodies within the framework of EC directives on medical devices下载
MR030 MEDDEV 2.12/1 rev.8 Guidelines on a medical devices vigilance system下载
MR031 MEDDEV 2.12/1 rev.8 Additional guidance on MEDDEV 2.12/1 rev.8下载
MR032 MEDDEV 2.12/1 rev 7 Field Safety Corrective Action-FSCA下载
MR033 DSVG 00Introduction to device specific vigilance guidance下载
MR034 DSVG 01Cardiac ablation vigilance reporting guidance下载
MR035 DSVG 02 Coronary stents vigilance reporting guidance下载
MR036 DSVG 03Cardiac implantable electronic devices (CIED)下载
MR037 DSVG 04Breast implants下载
MR038 MEDDEV 2.12/2 rev.2 Post market clinical follow-up studies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)下载
MR040 MEDDEV 2.14/1 rev.2IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES下载
MR041 MEDDEV 2.14/2 rev.1 Research use only products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下载
MR044 MEDDEV. 2.15 Rev.3 Committees/working groups contributing to the implementation of the medical device directives December 2008下载
MR045 MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers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下载
MR047 MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI下载
MR048 MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database下载
MR049 MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16下载
MR050 MDCG 2018-5 UDI assignment to medical device software下载
MR051 MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs下载
MR052 MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs下载
MR053 MDCG 2018-2 Future EU medical device nomenclature - Description of requirements下载
MR054 MDCG 2018-1 v3 Guidance on basic UDI-DI and changes to UDI-DI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下载
MR056 MDCG 2019-5 Registration of legacy devices in EUDAMED下载
MR057 MDCG 2019-4 Timelines for registration of device data elements in EUDAMED下载
MR058 MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional下载
MR059 MDCG 2020-17 Questions and Answers related to MDCG 2020-4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)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下载
MR065 MDCG 2019-14 Explanatory note on MDR codes下载
MR066 MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation下载
MR067 MDCG 2019-12 Designating authority's final assessment form: Key information (EN)下载
MR068 MDCG 2019-10 rev.1 Application of transitional provisions concerning validity of certificates issued in accordance to the directives下载
MR069 MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies下载
MR070 MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers下载
MR071 NBOG BPG 2017-1 Best practice guidance on designation and notification of conformity assessment bodies下载
MR072 NBOG BPG 2017-2 Best practice guidance on the information required for personnel involved in conformity assessment下载
MR073 NBOG F 2017-8 Review of qualification for the authorisation of personnel(IVDR)下载
MR074 NBOG F 2017-7 Review of qualification for the authorisation of personnel (MDR)下载
MR075 NBOG F 2017-6 Preliminary assessment review template (IVDR)下载
MR076 NBOG F 2017-5 Preliminary assessment review template (MDR)下载
MR077 NBOG F 2017-4 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)下载
MR078 NBOG F 2017-3 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)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)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)下载
MR081 MDCG2020-13 Clinical evaluation assessment report template下载
MR082 MDCG 2020-10/1 Guidance on safety reporting in clinical investigationsAppendix: Clinical investigation summary safety report form下载
MR083 MDCG 2020-10/2 Guidance on safety reporting in clinical investigationsAppendix: Clinical investigation summary safety report form下载
MR084 MDCG 2020-8 Guidance on PMCF evaluation report templateC下载
MR085 MDCG 2020-7 Guidance on PMCF plan template下载
MR086 MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices下载
MR087 MDCG 2020-5 Guidance on clinical evaluation – Equivalence下载
MR088 MDCG 2019-9 Summary of safety and clinical performance下载
MR089 MDCG 2020-1 Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software下载
MR090 MDCG 2019-16 rev.1 Guidance on cybersecurity for medical devices下载
MR091 MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746下载
MR092 MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746下载
MR093 MDCG 2020-9 Regulatory requirements for ventilators and related accessories下载
MR094 MDCG 2020-2 rev.1 Class I transitional provisions under Article 120 (3 and 4) – (MDR)下载
MR095 MDCG 2019-15 rev.1 Guidance notes for manufacturers of class I medical devices下载
MR096 MDCG 2019-8 v2 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices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)下载
MR098 MDCG 2019-3 rev.1 Interpretation of article 54(2)b下载
MR099Guidance on regulatory requirements formedical face masks Options for supporting production and/or placingon the market of medical face masks in the context of COVID-19 pandemic下载
MR100Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context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)下载
MR103 GHTF/SG4/N83:2010 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers –Part 4: Multiple Site Auditing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下载
MR105Guidance Notes for Manufacturers of Custom-Made Medical Devices下载
MR106Guidance document on Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements下载
MR107GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES下载
MR108 Recommendation-NB-MED-2_7-1_rev2 Recommendation-NB-MED-2_7-1_rev2 Guidance on clinicals下载
3. MDR其他清单
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MR109 CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions下载
MR110 Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19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下载
MR113NBM-003-19 Joint NB-Position Paper on Spinal Classification per the MDR下载
MR114NBM-046-18 One Year of Application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 2.3October,13th, 2014下载
MR116 Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012Version 1.1October 13th, 2014下载
MR117Recommendation-NB-MED-2.5.2 rec 2Recommendation-NB-MED-2.5.2 rec 2 Reporting of design changes and changes of the quality system下载
MR118NB-MED/2.5.1/Rec5 Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation下载
MR119Recommendation-NB-MED-2_15-1_rev3 Recommendation-NB-MED-2_15-1_rev3 Voluntary certification at an intermediate stage of manufacture下载
MR120Recommendation-NB-MED-2_13-2_rev3Recommendation-NB-MED-2_13-2_rev3 CE-Marking of established IVD devices下载
MR121NB-MED/2.13/Rec1 Recommendation-NB-MED-2_13-1_rev3 CE-Marking of pre-MDD devices下载
MR122NB-MED/2.12/Rec1 Recommendation-NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS)下载
MR123Recommendation-NB-MED-2_7-3_rev5Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data下载
MR124Recommendation-NB-MED-2_5_5-Rec5 Recommendation-NB-MED-2_5_5-Rec5 Conformity Assessment of Own Brand Labelling 下载
MR125Recommendation-NB-MED-2_5_5 Rec2 Recommendation-NB-MED-2_5_5 Rec2-Conformity assessment procedures for hip, knee and shoulder total下载
MR126NB-MED/2.5.5/Rec4 Recommendation-NB-MED-2_5_5-4_rev2 Assessment of the sensitivity of In Vitro Diagnostic Medical下载
MR127NB-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下载
MR128NB-MED/2.5.5/Rec1 Recommendation-NB-MED-2_5_5-1_rev5 Conformity assessment procedures of breast implants下载
MR129NB-MED-2_5_4-2_rev3 Recommendation-NB-MED-2_5_4-2_rev3 Verification of Manufactured Products for the IVD Directive下载
MR130NB-MED-2_5_4-1_rev4 Recommendation-NB-MED-2_5_4-1_rev4 Homogeneous batches下载
MR131NB-MED-2_5_2-3_rev9 Recommendation-NB-MED-2_5_2-3_rev9 Translation procedure下载
MR132NB-MED-2_5_2-1_rev4Recommendation-NB-MED-2_5_2-1_rev4 Subcontracting – QS related下载
MR133NB-MED-2_5_1-6_rev4 Recommendation-NB-MED-2_5_1-6_rev4 Renewal of EC Design-Examination and Type-Examination下载
MR134NB-MED-2_5_1-4_rev4 Recommendation-NB-MED-2_5_1-4_rev4 Content of mandatory certificates下载
MR135NB-MED-2_2 Rec1Recommendation-NB-MED-2_2 Rec1 EMC requirements下载
MR136NB-MED-2_2-4_rev5 Recommendation-NB-MED-2_2-4_rev5 Software and Medical Devices下载
MR137NB-MED/2.2/Rec3 Recommendation-NB-MED-2_2-3_rev4 ‘Use-by’ date for Medical Devices下载
MR138NB-MED-2_2-2_rev3Recommendation-NB-MED-2_2-2_rev3 Treatment of computer used to program Active Implantable Medical Devices (AIMD)下载
MR139NB-MED-2_1-5_rev5Recommendation-NB-MED-2_1-5_rev5 Placing on the market of fully refurbished medical devices下载
MR140NB-MED-2_1-4_rev7 Recommendation-NB-MED-2_1-4_rev7 Medical devices with a measuring function下载
MR141NB-MED-2_1-3_rev2Recommendation-NB-MED-2_1-3_rev2 Accessories and other parts for Active Implantable Medical下载
MR142NB-MED-2_1-2_rev5Recommendation-NB-MED-2_1-2_rev5 Explanation of Terms下载
MR143NB-MED-2_1-1_rev4Recommendation-NB-MED-2_1-1_rev4 Representative Sample下载
MR144NB-Med_2007-04 Recommendation_Vigilance_after NB-Med_2007-04下载
MR145 NB-MED letter to MS on 2007_47 implementation下载
MR146 Conformity assessment procedures for 3D printing and 3D printed productsto be used in a medical context for COVID-19下载
MR147 Insulin Infusion Pumps and Integrated meter systems下载
MR148 Instructions for use for reusable & re-sterilisable medical devices) e下载
MR149 Requirements for in vitro diagnostic kits measuring parameters which can be used for evaluating the risk of trisomy 21下载
MR150 Informative document of the Commission’s services on placing on the market of medical devices下载
MR151 Information on the Customs Union Agreement with Turkey in the field of medical devices下载
MR152 DECISION No 1/2006 OF THE EC-TURKEY ASSOCIATION COUNCIL of 15 May 2006下载
MR153 Statement of Turkey – EC Customs Union Joint Committee on the implementation of Article 1 of Decision 1/2006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下载
MR157 Information on the Medical Devices Directives in relation to medical device own brand labellers下载
MR1582013/172/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下载
MR1592013/473/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下载
MR1602005/50 / EC COMMISSION DIRECTIVE 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework ofCouncil Directive 93/42/EEC concerning medical devices下载
MR1612003/12/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)下载
MR162 (EU) 2020/666 Commission Implementing Regulation (EU) 2020/666 amendingImplementing Regulation (EU) No 920/2013 as regards the renewal ofdesignations and the surveillance and monitoring of notified bodies – OJ L153 of 10 May 2020下载
MR1632020/350 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下载
MR164 2002/364/EC COMMISSION DECISIONof 20 December 2011amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices下载
MR1652002/364/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下载
MR1662002/364/EC COMMISSION DECISION of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnosticmedical devices下载
MR167(EU) 2017/1445 COMMISSION IMPLEMENTING DECISION (EU) 2017/1445of 8 August 2017on the group of products whose principal intended action, depending onproanthocyanidins (PAC) present in cranberry (Vaccinium macrocarpon), is to prevent ortreat cystitis下载
MR168(EU) 920/2013 COMMISSION IMPLEMENTING REGULATION (EU) No 920/2013of 24 September 2013on the designation and the supervision of notified bodies under Council Directive90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC onmedical devices下载
MR169 COMMISSION DECISIONof 19 April 2010on the European Databank on Medical Devices (Eudamed)下载
MR170(EU) 722/2012 COMMISSION REGULATION (EU) No 722/2012of 8 August 2012concerning particular requirements as regards the requirements laid down in CouncilDirectives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin下载
MR1712003/32/EC Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications asregards the requirements laid down in Council Directive 93/42/EEC with respect tomedical devices manufactured utilising tissues of animal origin下载
MR172(EU) No 207/2012 COMMISSION REGULATION (EU) No 207/2012of 9 March 2012on electronic instructions for use of medical devices下载
MR1732011/100/EU COMMISSION DIRECTIVE 2011/100/EUof 20 December 2011amending Directive 98/79/EC of the European Parliament and of the Council on in-vitrodiagnostic medical devices下载
MR1742002/364/EC 2002/364/EC: Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices下载
MR1752020/0321 (COD) REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILon a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices下载
MR176 (EU) 2019/1396 COMMISSION IMPLEMENTING DECISION (EU) 2019/1396 of 10 September 2019laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliamentand of the Council as regards the designation of expert panels in the field of medical devices下载
MR177 IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746下载
MR178 Ongoing guidance development and other relevant work within MDCG Subgroups – December 2020下载
MR179 Guide to Using EUDAMEDActor registration modulefor economic operator下载
MR180 EUDAMED - User Rights and Obligations下载
MR181 DECLARATION ON INFORMATION SECURITYRESPONSIBILITIES IN THE CONTEXT OF THEEUROPEAN MEDICAL DEVICE DATABASE下载
MR182 EUDAMED-ACTOR MODULE FAQs下载
MR183 What are the dif_x005f fferent Actor roles in EUDAMED下载
MR184 ACTOR REGISTRATION REQUEST PROCESSFOR ECONOMIC OPERATORS EXCEPT NON-EU MANUFACTURER下载
MR185 EUDAMED Mandate Summary documentthat a non-EU manufacturer should provide in itsActor registration request下载
MR186 EUDAMED USER ACCESS REQUESTS下载
MR187 Actor Module - Business Process下载
MR188 Actor Module - Business Rules下载
MR189 AIM - Business Process下载
MR190 AIM - Business Rules下载
MR191Ref. Ares(2020)2944220 Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices下载
MR192 Current performance of COVID-19 test methods and devicesand proposed performance criteria下载
MR1932020/C 122 I/01 COMMUNICATION FROM THE COMMISSIONGuidelines on COVID-19 in vitro diagnostic tests and their performance(2020/C 122 I/01)下载
MR194 NOTICE TO STAKEHOLDERSWITHDRAWAL OF THE UNITED KINGDOM AND EU RULES FOR MEDICINAL PRODUCTSFOR HUMAN USE AND VETERINARY MEDICINAL PRODUCTS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下载
MR197 Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC下载
MR198 Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC andCommission Decision 2010/227/EU下载
MR199 CAMD Implementation TaskforceMedical Devices Regulation/In-vitro Diagnostics Regulation(MDR/IVDR) Roadmap下载
MR200 The safety of medical devices containing DEHPplasticizedPVC or other plasticizers on neonates and other groups possibly at risk (2015 update)下载
MR201 THE SAFETY OF MEDICAL DEVICES CONTAINING DEHPPLASTICIZEDPVC OR OTHER PLASTICIZERS ON NEONATES AND OTHER GROUPS POSSIBLY AT RISK下载
MR202 REPORT ON NANOTECHNOLOGY TO THE MEDICAL DEVICES EXPERT GROUPFINDINGS AND RECOMMENDATIONS下载
MR203 Instructions For Use for reusable andre‐sterilisable Medical Devices下载
MR204 Coronavirus: European standards for medical supplies made freely available to facilitate increase of production下载
MR205 Coronavirus: Commission issues guidelines on testing下载
MR2062016/425 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下载
MR2072020/403 COMMISSION RECOMMENDATION (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat下载
MR208 Factsheet for Manufacturers of medical devices下载
MR209 Implementation Model for medical devices Regulation Step by Step Guide下载
MR210 Factsheet for Manufacturers of in vitro diagnostic medical devices下载
MR211 Implementation Model for in vitro diagnostic medical devices RegulationStep by Step Guide下载
MR212 Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR)and Incidents (AIMDD/MDD/IVDD)下载
MR213 Factsheet for Authorised Representatives,Importers and Distributors of medical devices and in vitro diagnostic medical devices下载
MR214 Factsheet for Authorities in non-EU/EEA States on medical devices and in vitro diagnostic medical devices1下载
MR215 Factsheet for healthcare professionals and health institutions下载
MR216 Factsheet for Procurement Ecosystemof medical devices and in vitrodiagnostic medical devices下载
MR2172020/C 171/01 Guidelines on the adoption ofUnion-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745下载
MR218 List of COVID-19 essential Medical Devices (MDs and IVDs)下载
MR219 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions下载
MR220 New EU rules to ensure safety of medical devices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下载
MR222 Transition Timelines from the Directives to the medical devices Regulation下载
MR223 CLARIFICATION OF “RARE” BLOOD GROUPS AND SUBGROUPS下载
MR224 European Commission-European Medicines Agency Conference on the Operation of the Clinical TrialsDirective (Directive 2001/20/EC) and Perspectives for the Future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下载
MR226 OUTCOME OF THE FIRST PUBLIC CONSULTATION ON THE REPROCESSING OF MEDICAL DEVICES下载
MR227 WORKSHOP ON REPROCESSING OF MEDICAL DEVICES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下载
MR229 Transition Timelinesfrom the Directive to the in vitrodiagnostic medical devices Regulation下载
MR230 FAQ – IVDR Transitional provisions下载
MR231 State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioningof the new framework for medical devices under the MDR下载
MR232 Fact sheet on MDR requirements for Transparency and Public Information下载
MR233 Impact Assessment ofPolicy Options for Combating Counterfeiting of Medical Devices and for Developing Safer Distribution Channels for Parallel Trade in Medical Devices下载
MR234 The European Medical Device Nomenclature (EMDN)下载
MR235 OVERVIEW OF NBs AT EACH STAGE OF THE PROCESS下载
MR236 Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746下载
MR237 Unique Device Identification (UDI) of Medical Devices下载
MR238 GS1 AISBL APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)下载
MR239 HIBCC APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)下载
MR240 ICCBBA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)下载
MR241 IFA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)下载
MR242 GS1 UDI HRI & AIDC formats下载
MR243 GS1 General Specifications Change Notification (GSCN)下载
MR244 HIBCC UDI HRI & AIDC formats下载
MR245 HIBCC basic UDI-DI下载
MR246 ICCBBA UDI HRI & AIDC formats下载
MR247 ISBT 128 STANDARD Coding and Labeling of Medical Devices Containing MPHO下载
MR248 IFA UDI HRI & AIDC formats下载
MR249 IFA basic UDI-DI下载
MR250 GSI Sample UDI LabelsUDI Label Examples, HRI & Date Formatting…下载
MR251 GS1 General Specifications下载
MR252 HIBCC UDI Label Examples下载
MR253 Technical Information regarding PZN Coding- Check Digit Calculations of PZN, PPN and Basic UDI-DI -下载
MR254 IFA Coding SystemSpecification Unique Device Identification (UDI)下载
MR255 IFA Coding System PPN-Code Specification for Retail Packaging下载
MR256 List of Members Borderline and Classification Medical Devices Expert Group下载
MR257 MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITYREGULATORY FRAMEWORK FOR MEDICAL DEVICES下载
MR258 TERMS OF REFERENCE OF THE MEDICAL DEVICE COORDINATION GROUP下载
MR259 Medical devices - Regulatory framework下载
MR260 Management of Conflict of Interests (COI) of experts下载
MR261 TRoles and tasks of panels and experts:Terms of Reference Rules of Procedure Handling commercially confidential information下载
MR262 Applying the screening panel decision criteria in the context of the CECP下载
MR263 Workflow, operations and IT aspects下载
MR2642019/C 323/05 Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices下载
MR265 Central list of available experts下载
MR266 Evaluation of the“EUropean DAtabank on MEdical Devices”下载
MR267 MDR deviceBasic UDI-DI & UDI-DI attributesBasic UDI-DI set of data in UDI database下载
MR268 IVDRdeviceBasic UDI-DI & UDI-DI attributesBasic UDI-DI set of data in UDI database下载
MR269 Draft Functional specifications for the European Database on Medical Devices (Eudamed) -First release (High(1)) to be audited下载
MR270 Guidelines for Member States on the use of Data Exchange solutionsMDR EUDAMED下载
MR271 Eudamed Data Exchange Services andEntity Models Introduction下载
MR272 Machine-to-Machine (M2M) DataExchange Services Definition下载
MR273 MEDDEV 2.7/3 SAE Report Table v2下载
MR274 Designation and monitoring of notified bodies within the framework of EC directives on medical devicesAnnex 1下载
MR275 Designation and monitoring of notified bodies within the framework of EC directives on medical devicesAnnex 2下载
MR276 Designation and monitoring of notified bodies within the framework of EC directives on medical devicesAnnex 3下载
MR277 Designation and monitoring of notified bodies within the framework of EC directives on medical devicesAnnex 4下载
MR278 Manufacturer Incident Report (MIR) forSerious Incidents (MDR/IVDR)and Incidents (AIMDD/MDD/IVDD)下载
MR279 New manufacturer incident report for importing XML file* with AdobeProfessional下载
MR280 Manufacturer Incidents Report: request for the paunsecure the MIR form (PDF version)下载
MR281 New manufacturer incident report XSD file and XSL files下载
MR282 New manufacturer incident report help text下载
MR283 Manufacturer Incident Report (MIR) - Changelog下载
MR284 Questions and Answers document regarding theImplementation of the new Manufacturer Incident Report (MIR) Form下载
MR285 FSCA xml files下载
MR286 Urgent Field Safety NoticeDevice Commercial Name下载
MR287 Template for a Field Safety Notice Customer Reply FormCustomer Reply Form下载
MR288 Template for a Field Safety Notice Distributor/Importer Reply FormDistributor/Importer Reply Form下载
MR289 Questions and Answers to fill in the Field Safety Notice (FSN).下载
MR290 Report FormManufacturer’s Trend ReportMedical Devices Vigilance System下载
MR291 Manufacturer’s Periodic Summary Report (PSR)Medical Devices Vigilance System下载
MR292 Guidance on the vigilance system for CE-marked medical devicesDevice Specific Vigilance Guidance Template下载
MR293 INTERPRETATIVE DOCUMENT OF THE COMMISSION'S SERVICES1IMPLEMENTATION OF DIRECTIVE 2007/47/EC AMENDING DIRECTIVES 90/385/EEC, 93/42/EEC AND 98/8/EC下载
MR294 Form for the registration of manufacturers and devicesIn Vitro Diagnostic Medical Device Directive, Article 10下载
MR295 The European Medical Device Nomenclature (EMDN)下载
MR296 The CND Nomenclature ‘Classificazione Nazionale Dispositivi medici’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下载
MR299(EU) 2020/1207 laying down rules forthe 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下载
MR303 Conformity assessment procedures for protective equipment下载
MR304 Q&A on in vitro diagnostic medical device conformity assessment and performancein the context of COVID-19下载
感谢分享
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