Author: Belinda Dowsett
As the long-awaited deadline for the implementation of the European Medical Devices Regulations (EU MDR) finally draws near, it is now more important than ever to understand the applicable deadlines and effectively prepare for the implementation of the regulations and the transitional arrangements.
Due to the decision to delay implementation of the EU MDR as a result of the COVID-19 pandemic, the following implementation and transition timelines have been defined:
- December 2020 EUDAMED Actor Registration (Module 1) released
- 26 May 2021 Implementation date for the EU MDR
- September 2021 EUDAMED Unique Device Identifier (UDI) /Devices Registration and Notified Bodies / Certificates (expected release date for Module 2)
- 26 May 2024 EU MDD certificates expire
- 26 May 2025 Devices certified under the EU MDD can no longer be sold or distributed.
With the implementation date of MDR only months away, manufacturers and sponsors should consider preparing as follows:
- Confirm the classification of your device under the new EU MDR classification rules. As discussed in previous blogs and webinars, the changes to the classification rules have the potential to significantly impact manufacturers, particularly for those devices being up-classified from Class I. Reclassification may introduce a requirement for revisions to technical documentation, application for pre-market technical file review and implementation and certification of a Quality Management System, as just a few examples.
- Conduct a gap assessment of your documentation and procedures against the requirements of the EU MDR to identify any shortfalls in your existing documentation or processes. With a significant number of additional requirements now needed under the MDR, this is a critical step in understanding exactly the work required to achieve compliance with the new regulations.
- Develop a plan for establishing compliance in line with the applicable timelines, and work to close the gaps.
Let’s also not forget that the IVDR deadlines are hot on the heels of the MDR changes, and are scheduled for implementation on 26 of May 2022. Similar plans should be in place to ensure the distribution and release of IVD products are not interrupted by those changes.
As more devices (and of course IVDs) will now require notified body review as a result of reclassification, as well as the continuing shortage of notified bodies that are designated under MDR/IVDR, timelines for review are extensive. If you haven’t already, consider engaging with a notified body as soon as possible to assess the potential impact on your marketing and distribution plans.
Our team is here to support you with classification analyses, gap assessments, QMS implementation and engagements with European Notified bodies and Authorised Representatives to help you transition to the EU MDR and IVDR.