Clarivate regulatory expert Mónica Colina reviews key aspects of the European Commission’s Medical Device Regulation (MDR) to be considered for surveillance audits of medical devices certified under the repealed directives.
The European Commission’s Medical Device Regulation rules, first published in May 2017, became applicable in all European member states in May of this year. The The rules will apply to all devices seeking marketing authorization going forward, but products already on the market may continue to be certified under the older Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) rules for a time. These products, designated as legacy devices, must eventually be brought into compliance with the new regulation, per timelines set out in the transitional provisions of the MDR. In the meantime, however, there are some elements of the MDR that manufacturers of legacy devices could benefit from being aware of.
Medical devices having valid certificates under MDD will face surveillance audits involving some MDR requirements
Manufacturers, authorized representatives and other relevant economic operators involved in marketing and servicing these legacy devices in E.U. member states are called to update the technical documentation of their devices according to MDR safety and performance requirements in order to keep their certificate valid.
Technical files of legacy devices must be brought into compliance with some MDR requirements, even if they are otherwise certified under the MDD.
The advent of the MDR does not necessarily mean that companies must adapt the complete technical files prescribed by the new regulations right away. Instead, new documents can be added to supplement the preexisting files, although eventually, the complete technical file will need to be adapted. With MDR now in force, during surveillance audits of E.C. certificates, manufacturers can be asked to show evidence that they are in compliance with some requirements not scrutinized in previous audits due to differences between regulatory frameworks (MDD and AIMDD vs. MDR).
In order to ensure the greatest possible level of compliance with MDR policy, manufacturers must pay special attention to the development of the following documentation included in the technical files of their legacy devices:
- Post-market surveillance plans
- Post-market surveillance reports
- Trending reports
- Post-market clinical follow-up reports
- Market vigilance evidence (clinical evaluations and demonstrations of clinical evidence) as indicated in the Medical Device Coordination Group (MDCG) 2020-6: Guidance on Sufficient Clinical Evidence for Legacy Devices, Apr-2020.
Additional registration procedures needed to maintain the validity of legacy device certificates
In addition, E.U. MDR will require that manufacturers or their authorized representatives designate a medical device expert responsible for regulatory compliance for their organizations.
Another important requirement is implementation of the Unique Device Identification system (UDI) and registration of devices with their corresponding UDIs in the European Database on Medical Devices (EUDAMED) when available. Regardless of the fact that EUDAMED is not fully operative, UDI system compliance is already required for class III devices. It will become compulsory for class IIa and IIb devices in 2023, and for class I devices in 2025.
Recommendations for device manufacturers
Device manufacturers are plotting strategies to avoid slowdowns in R&D and innovation.
Based on landscape analysis and stakeholder perspectives, we recommend:
- conducting a gap analysis between MDD and MDR requirements before surveillance audits take place;
- paying special attention to changes in design, quality procedures, site location, critical suppliers or critical manufacturing processes that could potentially invalidate legacy device certificates;
- consulting the MDR to perform a gap analysis enabling harmonization of the quality management system to the new requirements, even for companies having valid quality management system certificates under relevant standards such as the ISO13485;
- hiring and training Quality Assurance and Regulatory Affairs staff in adequate numbers to absorb a heavy workload through the transitional period, helping prep internal teams and manage relationships with external regulatory authorities;
- planning strategies for certification under the new regulation as soon as possible, as design changes can accelerate loss of certification under the old directives.
Adapting to a new regulatory model is never a simple process, but by bearing in mind these considerations and doing due diligence to anticipate challenges, manufacturers can save themselves some extra effort and keep the wheels of innovation turning through the transition.
Insights provided in this article were developed by Clarivate analysts, using data and analysis from Cortellis Regulatory Intelligence™, which provides comprehensive, global and expertly-analyzed information that spans all regulatory functions across the R&D lifecycle.
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