EU Regulations on Medical Devices
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MEDICAL DEVICES – (MDD, MDR)
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Designation |
Title |
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No. 93/42/EEC |
Council Directive on Medical Devices |
) 2017/745 of the European Parliament and of the Council (EU) 2017/745, applicable from May 26, 2020; for exceptions, see Article 123 Entry into force and applicability |
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No. (EU) 2021/1433 |
Commission Recommendation on conformity assessment and market surveillance procedures in the context of the COVID-19 pandemic // Commission Recommendation (EU) 2020/403 |
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No. (EU) 2020/403, as corrected, |
Commission Recommendation on conformity assessment and market surveillance procedures in relation to the threat of COVID-19 |
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, No. (EU)2019/1396 |
Commission Implementing Decision laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the establishment of expert panels in the field of medical devices |
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No. (EU) 2018/1617 |
Commission Decision on a measure taken by France in accordance with Council Directive 93/42/EEC concerning the medical devices Terrafor and Defiligne |
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Commission Implementing Decision on a group of products whose main intended function, based on proanthocyanidins present in cranberries (Vaccinium macrocarpon), is the prevention or treatment of bladder infections// |
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Commission Decision on the European Database on Medical Devices (Eudamed) |
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Commission Implementing Decision laying down implementing rules for Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices |
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No. 207/2012 repealed |
Commission Regulation on electronic instructions for use of medical devices// |
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No. (EU) 2020/437, as amended |
Commission Implementing Decision on harmonized standards for medical devices drawn up in support of Council Directive 93/42/EEC |
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2017/C/389/3 repealed |
Commission Communication in the framework of the implementation of Council Directive 93/42/EEC on medical devices |
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No. (EU) 2017/2185 |
Commission Implementing Regulation on the list of codes and corresponding device types for the purpose of determining the scope of the designation of notified bodies in the field of medical devices pursuant to Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices pursuant to Regulation (EU) 2017/746 |
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No. 2017/2118 |
Agreement between the European Community and the Swiss Confederation on the mutual recognition of conformity assessment |
Newly issued EU legislation
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Reference |
Title |
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(EU)2017/745 |
Regulation of the European Parliament and of the Council 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 |
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Commission Implementing Regulation amending Implementing Regulation (EU) 2022/2346 as regards transitional provisions concerning certain products without a specific therapeutic purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council |
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No. (EU) 2022/2347 |
Commission Implementing Regulation laying down implementing rules for Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the reclassification of certain groups of active devices without a specific therapeutic purpose |
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No. (EU) 2022/2346 |
Commission Implementing Regulation laying down common specifications for groups of products without a specific therapeutic purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices |
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Commission Implementing Regulation laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European database on medical devices (Eudamed) |
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Commission Implementing Regulation laying down implementing rules for Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices; |
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(EU) 2021/1182 |
Commission Implementing Decision on harmonized standards for medical devices drawn up in support of Regulation (EU) 2017/745 of the European Parliament |
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Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 |
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| (EU) 2020/561 | Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the applicability of certain of its provisions |
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Commission Implementing Decision designating issuing entities designated to operate the system for the assignment of Unique Device Identifiers (UDI) in the field of medical devices |
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Council’s Explanatory Memorandum: Council Position (EU) No. 2/2017 at first reading on the adoption of a Regulation of the European Parliament and of the Council 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 |
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| 2017/C/116/01 | Council Position (EU) No. 2/2017 at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council 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 Adopted by the Council on 7 March 2017 |
