Introduction: Medical Device Regulation (MDR 2017/745)

The Medical Device Regulation (EU) 2017/745 (MDR) became fully applicable on 26 May 2021, replacing the former Medical Devices Directive (93/42/EEC). The MDR is directly applicable in all EU Member States and aims to increase the safety, transparency, and traceability of medical devices placed on the European market.

The MDR introduces extensive requirements related to:

• General safety and performance requirements (Annex I)
• Classification of medical devices (Annex VIII)
• Conformity assessment procedures (Annexes IX–XI)
• Technical documentation (Annexes II and III)
• Clinical evaluation and clinical investigations (Article 61 and Annex XIV)
• Post-market surveillance and vigilance (Articles 83–100)
• CE marking and the EU Declaration of Conformity (Articles 19 and 52)

The MDR also introduces new obligations for manufacturers, importers, and distributors, as well as the requirement to appoint a Person Responsible for Regulatory Compliance (PRRC) (Article 15).

Click here  to open the website from the European Union with the regulation.