The European Medical Device Regulation (EU MDR) came into effect in 2017, with medical device manufacturers originally having to comply by May 2020. The MDR deadline was amended due to the COVID-19 pandemic, which gave organisations until the 26th May 2021 to prepare. These MDR changes have impacted the way medical device manufacturers operate. In addition, it has also increased their compliance costs and significantly altered their change management processes.
Here are 5 things you should know about the current MDR:
1. The new MDR came into force on the 26th May 2021
On the 25th May 2017, the EU MDR formal publication was entered into force replacing the following existing directives:
- Active Implantable Medical Devices (AIMD)
- In-vitro Diagnostic Directive (IVDD)
- Medical Device Directive (MDD).
This was the start of a three-year EU MDR transition period for organisations to comply with the new requirements. Until the 25th May 2021, certificates under MDD were still valid, but all devices placed on the market from this date must now conform to the new MDR. Existing MDD certificates will remain valid, but will become void as of May 26th 2024.
2. Placing a product on the medical device market can now take longer
The MDD was 60 pages long, whereas the new MDR document has 174 pages filled with 123 articles across 10 chapters, with 17 annexes – so it would be fair to say that MDR is much more detailed than its predecessor. The Medical Device Regulation changes brought with it increased pre-market scrutiny involving assessments and validation from notified bodies. Moreover, all products have to be CE marked under the new regulation 2017/745. This means that placing and keeping a medical device on the European market can take longer than it previously did.
3. There have been changes that affect notified bodies and competent authorities
With MDR, notified bodies have increased responsibility for the assessment and certification of medical devices. They face heightened scrutiny from competent authorities and notified bodies are also required to consult with the European Commission on their clinical evaluation and post-market follow-up plans. These changes within the requirement of notified bodies have ultimately changed the way they interact with manufacturers. Unannounced audits of manufacturers have increased since the changes, and audit schedules have to be provided to national authorities ahead of time.
4. All medical devices will need to have been be re-assessed for compliance and certification
Now the MDR changes are in force, medical devices must comply with its requirements and certifications. So, it is likely they will have to be re-assessed, if they haven’t already. Based on the increased scrutiny on risks and safety within the regulation, some manufacturers will have had to reclassify and/or re-certify their products after the re-assessment. In terms of new products, there might be a requirement to carry out clinical investigations, collecting post-market data. Essentially, the MDR calls for medical device manufacturers to implement these re-assessments and recertifications in a timely manner so they can continue to operate in the EU market.
5. There is an emphasis on post-market surveillance
The new regulations include a heightened prominence on post-market surveillance. The need for medical device organisations to actively monitor the performance of their devices on the market for recertification is now greater than ever before. This post-market surveillance has also increased the recurrence of performance and safety reporting, necessitating the need for additional resources for organisations. Although this requirement is more time-consuming under MDR, it helps medical device organisations notice potential issues sooner. Addressing them earlier in the production cycle can reduce the manufacturer's liability and protect patients.
One of the reasons that the EU MDR was postponed is that organisations simply weren’t prepared. The standard stipulates that medical device manufacturers must have a quality management system in place to manage compliance, quality and risk activities. It takes time to implement and roll out a new system, so it’s vital to make sure your quality management system is fit for purpose.
Access your free MDR compliance toolkit today to help support you in meeting the correct requirements of the MDR and to ensure your compliance.