EU Regulations on Active Implantable Medical Devices

MEDICAL DEVICES - Active Implantable Medical Devices (AIMD)

Designation	Title
No. 90/385/EEC (current version)	Council Directive on the approximation of the laws of the Member States relating to active implantable medical devices // repealed and replaced by Regulation (EU)2017/745 , which applies from May 26, 2020; for exceptions, see Article 123 Entry into force and applicability
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 groups in the field of medical devices
(EU) 920/2013	Commission Implementing Regulation on the designation of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices and the supervision of such bodies
No. 2010/227/EU	Commission Decision on the European Database on Medical Devices (Eudamed)
No. 207/2012 repealed (in full as of May 26, 2024)	Commission Regulation on electronic instructions for use of medical devices (EU) 2021/2226 will repeal and replace Commission Regulation No. 207/2012, partially as of January 4, 2022, and in full as of May 26, 2024
No. 722/2012	Commission Regulation (EU) on specific requirements regarding the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with regard to active implantable medical devices and medical devices manufactured using tissues of animal origin
(EU) 2020/438, as amended by (EU) 2021/611 (hEN April 15, 2021) repealed	Commission Implementing Decision on harmonized standards for active implantable medical devices drawn up in support of Council Directive 90/385/EEC / consolidated version (EU)2020/438
2017/C/389/2	Commission Communication in the framework of the implementation of Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices // This list replaces the previous list published in the Official Journal of the EU

Newly issued EU legislation

Designation	Title
(EU)2017/745 text in PDF format as of January 1, 2026, unchanged (EU)2023/2197	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// The Regulation applies from May 26, 2020; for exceptions, see Article 123 "Entry into force and applicability" // Amendment (EU) 2020/561 postpones the entry into force of certain provisions of Regulation (EU) 2017/745 by one year// Amendment (EU) 2023/502 applies from March 11, 2023// Amendment (EU) 2023/607 applies from March 20, 2023//Amendment (EU) 2023/2197 applies from November 9, 2025 // Amendment (EU) 2024/1860 applies from July 9, 2024// Amendment (EU) 2025/2457 applies from January 1, 2026
(EU) 2021/2226	Commission Implementing Regulation laying down implementing rules for Regulation (EU) 2017/745 of the European Parliament and of the Council (EU) 2017/745 as regards electronic instructions for use of medical devices (repeals and replaces Commission Regulation No. 207/2012, partially as of January 4, 2022, and fully as of May 26, 2024)
2020/C/171/1	Guidance on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
(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
(EU) 2019/939	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 // The Regulation applies from May 26, 2020; for exceptions, see Article 123 "Entry into force and applicability"