Active implantable medical devices
Regulation (EU) 2017/745 aims to protect the human health and safety, smooth operation of the single market and to achieve the results for which the active implantable medical devices are intended.
The devices must not present risk to patients, medical personnel or others in contact with them. Every device must bear standard information, where possible by using recognised symbols, on its sterile pack and sales packaging.
Legal act:
Regulation (EU) 2017/745
Regulation (EU) 2020/561 amending Regulation (EU) 2017/745
Parts of Directive 90/385/EEC that remain active:
Regulation (EU) 2017/745, Article 122 - Repeal and Regulation (EU) 2020_561, Article 1.7
Consolidated act:
24/04/2020 of Regulation (EU) 2017/745
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Legal acts repealed by Regulation (EU) 2017/745:
Directive 90/385/EEC (Partial repeal from 25/05/2021, see "Current Legislation" for more informations)
Directive 93/42/EEC (Partial repeal from 25/05/2021, See: Medical devices)
Previous guidelines:
Guidelines on Medical Devices - Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 93/42/EEC and 90/385/EEC - September 2015
Guidelines on a Medical Devices vigilance system - January 2013
Additional Guidance Regarding the Vigilance System
M565 Standardisation request to the European Committee for Standardisation - 15 May 2020
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 - OJ L 90 I of 25 March 2020
Commission communication in the framework of the implementation of the Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices - OJ C 389 of 17 November 2017
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 - OJ C 8 of 11 January 2021
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) - 11 March 2020
Update joint assessments for publication - Overview of the bodies at each stage of the process - March 2020