The new Medical Device Regulations (2017/745) approved by the European Commission in May 2017  will necessitate widespread changes in how devices are manufactured and the level of compliance and clinical data required to bring them to the European market.            

All medical device organisations that serve the EU market need to consider how they will transition in time to meet the required MDR compliance deadlines. This will require drafting a transition plan for each of your devices and for your organisation as a whole, and then dedicating the resources needed to fulfil the new requirements.

KEY CHANGES IN THE NEW MDR

  • More effective Post Market Surveillance requirements
  • More detailed requirements and clinical evidence for Clinical Evaluation Reporting
  • QP type Responsible Person for product release must be designated for manufacturers
  • Increased level of compliance for UDI & labelling
  • Distributors & importers must now be regulated (MDR Arts 11-14)
  • IVD risk-based classification leading to many more devices falling under Notified Body scrutiny

 

KEY DATES TO REMEMBER

European medical device and IVD market registrants should bear in mind the remaining MDR and IVDR deadlines:

  • 25th May 2017 – Official entry into force of MDR 2017/745 and IVDR 2017/746
  • 25th November 2017 – Notified Bodies may apply for designation under the MDR and IVDR
  • 25th March 2020 – Eudamed will go live
  • 25th May 2020 – MDR date of application
  • 25th May 2022 – IVDR date of application
  • 25th May 2024 – AIMD, MDD and IVDD certificates become void; after this date devices no longer will be approved for the EU market under these certificates
  • 25th May 2025 – Devices no longer can be put into service in the EU using AIMD, MDD or IVDD certificates