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MDR法规和指南最新清单汇总

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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
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
MR003 2020/561 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
MR004 IVDD 98/79/EC DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  on in vitro diagnostic medical devices
MR005 MDD 93/42 / EEC COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
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)

2. MDR指南清单

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MR007 MEDDEV 2.1/1 Definitions of 'medical devices', 'accessory' and 'manufacturer
MR008 MEDDEV 2.1/2 rev.2 Field of application of directive 'active  implantable medical devices'
MR009 MEDDEV 2.1/2.1  Treatment of computers used to program  implantable pulse generators
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
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
MR012 MEDDEV 2.1/5 Medical devices with a measuring function
MR013 MEDDEV 2.1/6  Qualification and classification of stand alone software
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
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
MR016 MEDDEV 2.2/4  Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products
MR017 MEDDEV 2.4/1 rev.9 Classification of medical devices
MR018 MEDDEV 2.5/3 rev.2  Subcontracting quality systems related
MR019 MEDDEV 2.5/5 rev.3  Translation procedure
MR020 MEDDEV 2.5/6 rev.1  Homogenous batches (verification of manufacturers' products)
MR021 MEDDEV 2.5/7 rev.1  Conformity assessment of breast implants
MR022 MEDDEV 2.5/9 rev.1  Evaluation of medical devices incorporating products containing natural rubber latex
MR023 MEDDEV 2.5/10 Guideline for authorised representatives
MR024 MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies
MR025 MEDDEV 2.7/1  Appendix 1 Appendix 1: Clinical evaluation on coronary stents
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
MR027 MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC
MR028 MEDDEV 2.7/4  Guidelines on clinical investigations: a guide for manufacturers and notified bodies
MR029 MEDDEV 2.10/2 rev.1 Designation and monitoring of notified bodies within the framework of EC directives on medical devices
MR030 MEDDEV 2.12/1 rev.8 Guidelines on a medical devices vigilance system
MR031 MEDDEV 2.12/1 rev.8 Additional guidance on MEDDEV 2.12/1 rev.8
MR032 MEDDEV 2.12/1 rev 7 Field Safety Corrective Action-FSCA
MR033 DSVG 00  Introduction to device specific vigilance guidance
MR034 DSVG 01  Cardiac ablation vigilance reporting guidance
MR035 DSVG 02 Coronary stents vigilance reporting guidance
MR036 DSVG 03  Cardiac implantable electronic devices (CIED)
MR037 DSVG 04  Breast implants
MR038 MEDDEV 2.12/2 rev.2 Post market clinical follow-up studies
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)
MR040 MEDDEV 2.14/1 rev.2  IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
MR041 MEDDEV 2.14/2 rev.1 Research use only products
MR042 MEDDEV 2.14/3 rev.1 Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices
MR043 MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP
MR044 MEDDEV. 2.15 Rev.3 Committees/working groups contributing to the implementation of the medical device directives December 2008
MR045 MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
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
MR047 MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI
MR048 MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database
MR049 MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16
MR050 MDCG 2018-5 UDI assignment to medical device software
MR051 MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs
MR052 MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs
MR053 MDCG 2018-2 Future EU medical device nomenclature - Description of requirements
MR054 MDCG 2018-1 v3 Guidance on basic UDI-DI and changes to UDI-DI
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
MR056 MDCG 2019-5 Registration of legacy devices in EUDAMED
MR057 MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
MR058 MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MR059 MDCG 2020-17 Questions and Answers related to MDCG 2020-4
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)
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
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
MR063 MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions
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
MR065 MDCG 2019-14 Explanatory note on MDR codes
MR066 MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation
MR067 MDCG 2019-12 Designating authority's final assessment form: Key information (EN)
MR068 MDCG 2019-10 rev.1 Application of transitional provisions concerning validity of certificates issued in accordance to the directives
MR069 MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies
MR070 MDCG 2018-8 Guidance on content of the certificates, voluntary certificate transfers
MR071 NBOG BPG 2017-1 Best practice guidance on designation and notification of conformity assessment bodies
MR072 NBOG BPG 2017-2 Best practice guidance on the information required for personnel involved in conformity assessment
MR073 NBOG F 2017-8 Review of qualification for the authorisation of personnel(IVDR)
MR074 NBOG F 2017-7 Review of qualification for the authorisation of personnel (MDR)
MR075 NBOG F 2017-6 Preliminary assessment review template (IVDR)
MR076 NBOG F 2017-5 Preliminary assessment review template (MDR)
MR077 NBOG F 2017-4 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
MR078 NBOG F 2017-3 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
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)
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)
MR081 MDCG2020-13 Clinical evaluation assessment report template
MR082 MDCG 2020-10/1 Guidance on safety reporting in clinical investigations  Appendix: Clinical investigation summary safety report form
MR083   MDCG 2020-10/2 Guidance on safety reporting in clinical investigations  Appendix: Clinical investigation summary safety report form
MR084 MDCG 2020-8 Guidance on PMCF evaluation report templateC
MR085 MDCG 2020-7 Guidance on PMCF plan template
MR086 MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MR087 MDCG 2020-5 Guidance on clinical evaluation – Equivalence
MR088 MDCG 2019-9 Summary of safety and clinical performance
MR089 MDCG 2020-1 Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software
MR090 MDCG 2019-16 rev.1 Guidance on cybersecurity for medical devices
MR091 MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MR092 MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
MR093 MDCG 2020-9 Regulatory requirements for ventilators and related accessories
MR094 MDCG 2020-2 rev.1 Class I transitional provisions under Article 120 (3 and 4) – (MDR)
MR095 MDCG 2019-15 rev.1 Guidance notes for manufacturers of class I medical devices
MR096 MDCG 2019-8 v2 Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices
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)
MR098 MDCG 2019-3 rev.1 Interpretation of article 54(2)b
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
MR100  Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
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
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)
MR103 GHTF/SG4/N83:2010 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers –Part 4: Multiple Site Auditing
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
MR105  Guidance Notes for Manufacturers of Custom-Made Medical Devices
MR106  Guidance document on Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements
MR107  GUIDANCE NOTE FOR MANUFACTURERS OF CUSTOM-MADE MEDICAL DEVICES
MR108 Recommendation-NB-MED-2_7-1_rev2 Recommendation-NB-MED-2_7-1_rev2 Guidance on clinicals

3. MDR其他清单

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MR109   CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions
MR110   Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
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
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
MR113  NBM-003-19 Joint NB-Position Paper on Spinal Classification per the MDR
MR114  NBM-046-18 One Year of Application
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
MR116   Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012  Version 1.1  October 13th, 2014
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
MR118  NB-MED/2.5.1/Rec5 Recommendation-NB-MED-R2_5_1-5_rev4 Technical Documentation
MR119  Recommendation-NB-MED-2_15-1_rev3 Recommendation-NB-MED-2_15-1_rev3 Voluntary certification at an intermediate stage of manufacture
MR120  Recommendation-NB-MED-2_13-2_rev3  Recommendation-NB-MED-2_13-2_rev3 CE-Marking of established IVD devices
MR121  NB-MED/2.13/Rec1 Recommendation-NB-MED-2_13-1_rev3 CE-Marking of pre-MDD devices
MR122  NB-MED/2.12/Rec1 Recommendation-NB-MED-2_12-1_rev11 Post-Marketing Surveillance (PMS)
MR123  Recommendation-NB-MED-2_7-3_rev5  Recommendation-NB-MED-2_7-3_rev5 Evaluation of clinical data
MR124  Recommendation-NB-MED-2_5_5-Rec5 Recommendation-NB-MED-2_5_5-Rec5 Conformity Assessment of Own Brand Labelling 
MR125  Recommendation-NB-MED-2_5_5 Rec2 Recommendation-NB-MED-2_5_5 Rec2-Conformity assessment procedures for hip, knee and shoulder total
MR126  NB-MED/2.5.5/Rec4 Recommendation-NB-MED-2_5_5-4_rev2 Assessment of the sensitivity of In Vitro Diagnostic Medical
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
MR128  NB-MED/2.5.5/Rec1 Recommendation-NB-MED-2_5_5-1_rev5 Conformity assessment procedures of breast implants
MR129  NB-MED-2_5_4-2_rev3 Recommendation-NB-MED-2_5_4-2_rev3 Verification of Manufactured Products for the IVD Directive
MR130  NB-MED-2_5_4-1_rev4 Recommendation-NB-MED-2_5_4-1_rev4 Homogeneous batches
MR131  NB-MED-2_5_2-3_rev9 Recommendation-NB-MED-2_5_2-3_rev9 Translation procedure
MR132  NB-MED-2_5_2-1_rev4  Recommendation-NB-MED-2_5_2-1_rev4 Subcontracting – QS related
MR133  NB-MED-2_5_1-6_rev4 Recommendation-NB-MED-2_5_1-6_rev4 Renewal of EC Design-Examination and Type-Examination
MR134  NB-MED-2_5_1-4_rev4 Recommendation-NB-MED-2_5_1-4_rev4 Content of mandatory certificates
MR135  NB-MED-2_2 Rec1  Recommendation-NB-MED-2_2 Rec1 EMC requirements
MR136  NB-MED-2_2-4_rev5 Recommendation-NB-MED-2_2-4_rev5 Software and Medical Devices
MR137  NB-MED/2.2/Rec3 Recommendation-NB-MED-2_2-3_rev4 ‘Use-by’ date for Medical Devices
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)
MR139  NB-MED-2_1-5_rev5  Recommendation-NB-MED-2_1-5_rev5 Placing on the market of fully refurbished medical devices
MR140  NB-MED-2_1-4_rev7 Recommendation-NB-MED-2_1-4_rev7 Medical devices with a measuring function
MR141  NB-MED-2_1-3_rev2  Recommendation-NB-MED-2_1-3_rev2 Accessories and other parts for Active Implantable Medical
MR142  NB-MED-2_1-2_rev5  Recommendation-NB-MED-2_1-2_rev5 Explanation of Terms
MR143  NB-MED-2_1-1_rev4  Recommendation-NB-MED-2_1-1_rev4 Representative Sample
MR144  NB-Med_2007-04 Recommendation_Vigilance_after NB-Med_2007-04
MR145   NB-MED letter to MS on 2007_47 implementation
MR146   Conformity assessment procedures for 3D printing and 3D printed products  to be used in a medical context for COVID-19
MR147   Insulin Infusion Pumps and Integrated meter systems
MR148   Instructions for use for reusable & re-sterilisable medical devices) e
MR149   Requirements for in vitro diagnostic kits measuring parameters which can be used for evaluating the risk of trisomy 21
MR150   Informative document of the Commission’s services on placing on the market of medical devices
MR151   Information on the Customs Union Agreement with Turkey in the field of medical devices
MR152   DECISION No 1/2006 OF THE EC-TURKEY ASSOCIATION COUNCIL of 15 May 2006
MR153   Statement of Turkey – EC Customs Union Joint Committee on the implementation of Article 1 of Decision 1/2006
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
MR155   Information on the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment
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
MR157   Information on the Medical Devices Directives in relation to medical device own brand labellers
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
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
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
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)
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
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
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
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
MR166  2002/364/EC COMMISSION DECISION of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnosticmedical devices
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
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
MR169   COMMISSION DECISION  of 19 April 2010  on the European Databank on Medical Devices (Eudamed)
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
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
MR172  (EU) No 207/2012 COMMISSION REGULATION (EU) No 207/2012  of 9 March 2012  on electronic instructions for use of medical devices
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
MR174  2002/364/EC 2002/364/EC: Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices
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
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
MR177   IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MR178   Ongoing guidance development and other relevant work within MDCG Subgroups – December 2020
MR179   Guide to Using EUDAMED  Actor registration module  for economic operator
MR180   EUDAMED - User Rights and Obligations
MR181   DECLARATION ON INFORMATION SECURITY  RESPONSIBILITIES IN THE CONTEXT OF THE  EUROPEAN MEDICAL DEVICE DATABASE
MR182   EUDAMED-ACTOR MODULE FAQs
MR183     What are the dif_x005ffferent Actor roles in EUDAMED
MR184   ACTOR REGISTRATION REQUEST PROCESS  FOR ECONOMIC OPERATORS EXCEPT NON-EU MANUFACTURER
MR185   EUDAMED Mandate Summary document  that a non-EU manufacturer should provide in its  Actor registration request
MR186   EUDAMED USER ACCESS REQUESTS
MR187   Actor Module - Business Process
MR188   Actor Module - Business Rules
MR189   AIM - Business Process
MR190   AIM - Business Rules
MR191  Ref. Ares(2020)2944220 Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices
MR192   Current performance of COVID-19 test methods and devices  and proposed performance criteria
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)
MR194   NOTICE TO STAKEHOLDERS  WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES FOR MEDICINAL PRODUCTS  FOR HUMAN USE AND VETERINARY MEDICINAL PRODUCTS
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
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
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
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
MR199   CAMD Implementation Taskforce  Medical Devices Regulation/In-vitro Diagnostics Regulation  (MDR/IVDR) Roadmap
MR200   The safety of medical devices containing DEHPplasticized  PVC or other plasticizers on neonates and other groups possibly at risk (2015 update)
MR201   THE SAFETY OF MEDICAL DEVICES CONTAINING DEHPPLASTICIZED  PVC OR OTHER PLASTICIZERS ON NEONATES AND OTHER GROUPS POSSIBLY AT RISK
MR202   REPORT ON NANOTECHNOLOGY TO THE MEDICAL DEVICES EXPERT GROUP  FINDINGS AND RECOMMENDATIONS
MR203   Instructions For Use for reusable and  re‐sterilisable Medical Devices
MR204   Coronavirus: European standards for medical supplies made freely available to facilitate increase of production
MR205   Coronavirus: Commission issues guidelines on testing
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
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
MR208   Factsheet for Manufacturers of medical devices
MR209   Implementation Model for medical devices Regulation Step by Step Guide
MR210   Factsheet for Manufacturers of in vitro diagnostic medical devices
MR211   Implementation Model for in vitro diagnostic medical devices Regulation  Step by Step Guide
MR212   Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR)  and Incidents (AIMDD/MDD/IVDD)
MR213   Factsheet for Authorised Representatives,Importers and Distributors of medical devices and in vitro diagnostic medical devices
MR214   Factsheet for Authorities in non-EU/EEA States on medical devices and in vitro diagnostic medical devices1
MR215   Factsheet for healthcare professionals and health institutions
MR216   Factsheet for Procurement Ecosystem  of medical devices and in vitro  diagnostic medical devices
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
MR218   List of COVID-19 essential Medical Devices (MDs and IVDs)
MR219   amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
MR220   New EU rules to ensure safety of medical devices
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
MR222   Transition Timelines from the Directives to the medical devices Regulation
MR223   CLARIFICATION OF “RARE” BLOOD GROUPS AND SUBGROUPS
MR224   European Commission-European Medicines Agency Conference on the Operation of the Clinical Trials  Directive (Directive 2001/20/EC) and Perspectives for the Future
MR225   INTERPRETATION OF THE RELATION BETWEEN THE REVISED DIRECTIVE 93/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 89/686/EEC ON PERSONAL PROTECTIVE EQUIPMENT
MR226   OUTCOME OF THE FIRST PUBLIC CONSULTATION ON THE REPROCESSING OF MEDICAL DEVICES
MR227   WORKSHOP ON REPROCESSING OF MEDICAL DEVICES
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
MR229   Transition Timelines  from the Directive to the in vitro  diagnostic medical devices Regulation
MR230   FAQ – IVDR Transitional provisions
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
MR232   Fact sheet on MDR requirements for Transparency and Public Information
MR233   Impact Assessment of  Policy Options for Combating Counterfeiting of Medical Devices and for Developing Safer Distribution Channels for Parallel Trade in Medical Devices
MR234   The European Medical Device Nomenclature (EMDN)
MR235   OVERVIEW OF NBs AT EACH STAGE OF THE PROCESS
MR236   Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746
MR237   Unique Device Identification (UDI) of Medical Devices
MR238   GS1 AISBL APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)
MR239   HIBCC APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)
MR240   ICCBBA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)
MR241   IFA APPLICATION to the EUROPEAN COMMISSION for designation as an issuing entity for Unique Device Identifiers (UDIs)
MR242   GS1 UDI HRI & AIDC formats
MR243   GS1 General Specifications Change Notification (GSCN)
MR244   HIBCC UDI HRI & AIDC formats
MR245   HIBCC basic UDI-DI
MR246   ICCBBA UDI HRI & AIDC formats
MR247   ISBT 128 STANDARD Coding and Labeling of Medical Devices Containing MPHO
MR248   IFA UDI HRI & AIDC formats
MR249   IFA basic UDI-DI
MR250   GSI Sample UDI Labels  UDI Label Examples, HRI & Date Formatting…
MR251   GS1 General Specifications
MR252   HIBCC UDI Label Examples
MR253   Technical Information regarding PZN Coding- Check Digit Calculations of PZN, PPN and Basic UDI-DI -
MR254   IFA Coding System  Specification Unique Device Identification (UDI)
MR255   IFA Coding System PPN-Code Specification for Retail Packaging
MR256   List of Members Borderline and Classification Medical Devices Expert Group
MR257   MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY  REGULATORY FRAMEWORK FOR MEDICAL DEVICES
MR258   TERMS OF REFERENCE OF THE MEDICAL DEVICE COORDINATION GROUP
MR259   Medical devices - Regulatory framework
MR260   Management of Conflict of Interests (COI) of experts
MR261   TRoles and tasks of panels and experts:Terms of Reference Rules of Procedure Handling commercially confidential information
MR262   Applying the screening panel decision criteria in the context of the CECP
MR263   Workflow, operations and IT aspects
MR264  2019/C 323/05 Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices
MR265   Central list of available experts
MR266   Evaluation of the“EUropean DAtabank on MEdical Devices”
MR267   MDR device  Basic UDI-DI & UDI-DI attributes  Basic UDI-DI set of data in UDI database
MR268   IVDRdevice  Basic UDI-DI & UDI-DI attributes  Basic UDI-DI set of data in UDI database
MR269   Draft Functional specifications for the European Database on Medical Devices (Eudamed) -First release (High(1)) to be audited
MR270   Guidelines for Member States on the use of Data Exchange solutions  MDR EUDAMED
MR271   Eudamed Data Exchange Services and  Entity Models Introduction
MR272   Machine-to-Machine (M2M) Data  Exchange Services Definition
MR273   MEDDEV 2.7/3 SAE Report Table v2
MR274   Designation and monitoring of notified bodies within the framework of EC directives on medical devices  Annex 1
MR275   Designation and monitoring of notified bodies within the framework of EC directives on medical devices  Annex 2
MR276   Designation and monitoring of notified bodies within the framework of EC directives on medical devices  Annex 3
MR277   Designation and monitoring of notified bodies within the framework of EC directives on medical devices  Annex 4
MR278   Manufacturer Incident Report (MIR) for  Serious Incidents (MDR/IVDR)  and Incidents (AIMDD/MDD/IVDD)
MR279   New manufacturer incident report for importing XML file* with Adobe  Professional
MR280   Manufacturer Incidents Report: request for the pa  unsecure the MIR form (PDF version)
MR281   New manufacturer incident report XSD file and XSL files
MR282   New manufacturer incident report help text
MR283   Manufacturer Incident Report (MIR) - Changelog
MR284   Questions and Answers document regarding the  Implementation of the new Manufacturer Incident Report (MIR) Form
MR285   FSCA xml files
MR286   Urgent Field Safety Notice  Device Commercial Name
MR287   Template for a Field Safety Notice Customer Reply Form  Customer Reply Form
MR288   Template for a Field Safety Notice Distributor/Importer Reply Form  Distributor/Importer Reply Form
MR289   Questions and Answers to fill in the Field Safety Notice (FSN).
MR290   Report Form  Manufacturer’s Trend Report  Medical Devices Vigilance System
MR291   Manufacturer’s Periodic Summary Report (PSR)  Medical Devices Vigilance System
MR292   Guidance on the vigilance system for CE-marked medical devices  Device Specific Vigilance Guidance Template
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
MR294   Form for the registration of manufacturers and devices  In Vitro Diagnostic Medical Device Directive, Article 10
MR295   The European Medical Device Nomenclature (EMDN)
MR296   The CND Nomenclature ‘Classificazione Nazionale Dispositivi medici’
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
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
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
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
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
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
MR303   Conformity assessment procedures for protective equipment
MR304   Q&A on in vitro diagnostic medical device conformity assessment and performance  in the context of COVID-19

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