What does the EU Medical Devices Regulation 2017/745, which will apply from 26 May, change? Here are their main contributions

26 May is the deadline to start implementing EU Regulation 2017/745 on Medical Devices, known as “MDR”. Many still do not know how this will affect the regulation of medical devices and what the main differences are. This is why we explain what’s new at some points.

The MDR repeals Directive 90/385/EEC (AIMDD) and Directive 93/42/EEC (MDD). This document, which entered into force on 25 May 2017 and will apply from 26 May 2020, regulates:

  • Medical devices for human use and related accessories
  • Devices not commercially marketed but used in the context of a commercial activity to provide a diagnostic or therapeutic service through information society services or other means of communication
  • Products not intended for medical use and listed in Annex XVI

What are the main differences between the MDR and the Directives?

In general, the MDR introduces new classification rules and amends some provisions. The aim is to make the classification criteria generally more rigorous:

  • It defines the economic operators (medical device manufacturer, agent, importer and distributor) and their specific obligations.
  • It provides for the need for the medical device manufacturer to have financial coverage and a person responsible for compliance with the law.
  • It requires the manufacturer to have a system for risk management, post-market surveillance and incident reporting.
  • Reinforces the need for the medical device manufacturer to demonstrate compliance with clinical data.
  • Comprehensively covers the preparation of specific documents by the manufacturer (safety and clinical performance summary for class III devices and implantable devices, post-market surveillance report for class I devices, etc.)
  • It regulates and strengthens medical device traceability with the creation of the UDI (Unique Device Identification) system.
  • It also enhances the use of the European Database for Medical Devices (EUDAMED) to collect device information in a single database.
  • It withdraws conformity assessment procedures that were based on product quality assurance and statistical verification.

At EpisKey Medical Consulting we provide you with the necessary regulatory consultancy and advise you on the adaptation to the new regulations.

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