Five things to know about the new European Medical Device Regulation
With the full application of the European Medical Device Regulation (MDR) coming in to effect next year, this new regulation is likely to impact the way in which medical device manufacturers operate, increase their compliance costs, and significantly alter their change management processes.
Below, I’ve highlighted five things you should know about the changes before they come into place:
- The deadline for the new MDR is the 26th of May 2020
On the 25th of 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), and; Medical Device Directive (MDD). This was the start of a three-year transition period for Medical Device organisations to comply with the new requirements. Until the 25th of May 2020, certificates under MDD are still valid but all devices placed on the market from the 26th of May next year must conform to the new MDR.
- Placing a product on the medical device market may take longer
The MDD was 60 pages long whereas the new MDR document has 174 pages filled with 123 articles across ten chapters, with 17 annexes – so it would be fair to say that the MDR is much more detailed than its predecessor. The new MDR brings with it increased pre-market scrutiny involving assessments and validation from Notified Bodies. Moreover, all products will have to be CE marked under the new regulation 2017/745. This means that placing and keeping a medical device on the European market may take longer than it previously did.
- There will be changes which will affect Notified Bodies and Competent Authorities
Under the new MDR, Notified Bodies will have increased responsibility for the assessment and certification of medical devices. They will face heightened scrutiny from Competent Authorities, and Notified Bodies will also be 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 will ultimately change the way in which they interact with manufacturers. Unannounced audits of manufacturers are likely to increase, and audit schedules will have to be provided to national authorities ahead of time.
- All medical devices need to be re-assessed for compliance and certification
With the new MDR, medical devices need to comply with requirements and certifications so it is likely they will have to be re-assessed. Based on the increased scrutiny on risks and safety within the regulation, some manufacturers will have to reclassify and/or recertify 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 that they can continue to operate in the EU market.
- There will be an emphasis on post-market surveillance
The new MDR will 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 will be greater than ever before. The post-market surveillance will also increase the recurrence of performance and safety reporting, which might necessitate the need for additional resources for organisations. Although this requirement will be more time-consuming under the MDR, it will help medical device organisations to notice potential issues sooner – and addressing them earlier in the production cycle could reduce the manufacturer's liability and protect patients.
For more information and help on how you and your organisation can ensure a smooth transition from MDD to MDR, access your free toolkit today.