Home / Insight / MDR

MDR

Medical Devices Regulation

Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). In 2017 two new regulations – one on medical devices and the other on in vitro diagnostic medical devices entered into force. The Medical Devices Regulation (MDR) replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMD). The In vitro diagnostic Medical Devices Regulation (IVDR) replaces the In Vitro Diagnostic Medical Devices Directive (IVDMD). As of May 2017, this new European legislation is in force and applies to all medical device manufacturers who intend to place their products in the European Union (EU).

The new rules will only fully apply after a transitional period. Based on the adoption of the amendment to postpone the application of the MDR by 1 year (European Commission, 23 April 2020), that period lasts for 4 years (instead of 3) after the entry into force of the MDR (i.e. until May 2021). This postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. For the in vitro diagnostic medical devices the transitional period is 5 years after the entry into force of the IVDR (i.e. until May 2022).

The aim of the MDR and IVDR is to increase patient safety and to ensure that innovative medical devices remain available to patients.

The legislation will significantly increase the regulatory and liability burden for manufacturers and suppliers of these products. Most Life Sciences companies face very challenging timelines to comply with this legislation: by May 2021 for general medical devices, and by May 2022 for in vitro diagnostic medical devices.

The key changes of the MDR/IMDR

  • Wider scope of regulated medical devices
  • More stringent clinical evidence and documentation
  • Increased focus on identification and traceability
  • Definition of common specification
  • Unannounced factory audits
  • Increased Notified Body authority and/or involvement
  • More rigorous vigilance and market surveillance
  • At least one person responsible for regulatory compliance

Some of the challenges we see

  • Notified bodies situation
  • Software as Medical Device
  • Up-classification
  • Scope of MDR / Definition
  • Contracts
  • New economic operators
  • Product liability
  • Inducement rules

Explore more

New Legislation
Current Legislation
Standards

Feed

15/09/2022
Pharmaceutical advertising regulation and medical device advertising in...
1. Which laws are applicable regarding advertising of medicines and medical devices? 1.1 Medicines The Medicines Act is the primary law on advertising of medicines. In addition, the Dutch Civil Code...
17/06/2020
Podcast: Advertising of Medicines and Medical Devices
The series brings together CMS lawyers and experts to discuss key industry topics impacting, innovating and disrupting the life sciences & healthcare sector.  In Episode #2, Nick Beckett (China/Hong...
26/03/2020
European Commission proposes delaying the May 2020 application of the EU...
The European Commission has confirmed it is working on a proposal to delay for one year the date of application of the new EU Medical Devices Regulation 2017/745/EU (the “MDR”) in light of the Covid-19...
06/03/2020
MDR - Agreements with third party contract manufacturers
The EU Medical Device Regulation, which comes into force on 26 May 2020, will lead not only to big changes in how medical devices are regulated, but also to more thought being given to agreements between...
17/01/2020
New guidance on cybersecurity for medical devices published
In December 2019, the Medical Device Coordination Group (“MDCG”) issued a new guidance to help medical device manufacturers meet the cybersecurity requirements in the Medical Devices Regulation (“MDR”)...
02/05/2017
New regulation on medical devices
Introduction The current legal framework for medical devices in the European Union is based on the following Directives, adopted in the 1990s: § Directive 90/385/EEC, active implantable medical devices...