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EU Medical Device Regulation

Effective Date: 26 May 2020

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In past decades, regulation of the medical device industry in Europe has remained relatively stable. However, recent events have resulted in vital regulatory & compliance reforms to the medical devices industry. The new Medical Devices Regulation adopted by EU, replaced two existing directives - Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive. To meet the new EU MDR objective, organizations will need to take a structured and well-managed approach over the next 3 years.

  Key changes

  • Expansion of products that are covered under Medical devices and Active Implantable Medical Devices that may not have medical intended purpose.

  • Stricter control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level.

  • Reinforcement of criteria for designation and processes for identification of Notified Bodies

  • EU MDR mandates the use of Unique Device Identification for improved transparency to enhance the ability of the manufacturers and Health Authorities to trace specific devices through the supply chain, and to facilitate the timely and efficient recall of medical devices those found to present a safety risk.

  • Reinforcement of rules on clinical evidence, including an EU-wide coordinated procedure for authorization of multi-center clinical investigations.

  • Strengthening of post-market surveillance requirements for manufacturers to reduce risks from unsafe devices

  • Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.

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