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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 | |
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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_x005f fferent 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 | |
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MR246 ICCBBA UDI HRI & AIDC formats | |
MR247 ISBT 128 STANDARD Coding and Labeling of Medical Devices Containing MPHO | |
MR248 IFA UDI HRI & AIDC formats | |
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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 | |
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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 | |
发表于 2021-3-26 15:49:41