After two decades of work, the EU’s new medical device and in vitro regulations are nearing their final approval stretch.
The European Council and the European Parliament is set to vote on the regulations. If passed, the regulations could become effective as early as May. Manufacturers would then have three years to comply with the MDR and five years to comply with the IVDR.
The two documents, which total 566 and 477 pages respectively, completely revamp the EU’s existing regulatory framework.
The MDR will require risk management and quality management systems, the use of unique device identifiers and tighter control over distribution chains. It replaces EU Directives 90/385 (Active Implantable Medical Devices) and 93/42 (Directive Concerning Medical Devices).
One of the most significant provisions in the EU’s new MDR restricts the types of clinical data manufacturers can use in clinical evaluation reports.
Previously, clinical data for new devices have been drawn mainly from available literature for equivalent or partially equivalent devices. By contrast, the MDR requires manufacturers to perform their own clinical evaluations for higher-risk Class III and implantable products, according to Gert Bos, executive director and partner at Qserve Group.
The evaluations must include an analysis of the relevant scientific literature, an analysis of the results of all available clinical trials, and a consideration of any currently available alternative treatment options. But there is an exception for Class III devices that have merely been modified and are substantially equivalent to currently marketed version.
Existing clinical evaluations for equivalent products can be used for Class II devices, but only if the data were collected according to the MDR’s standards. Manufacturers relying on equivalence will need to ensure they have access to relevant post-market surveillance data — especially clinical data — and fill in any gaps in collection or analysis.
Another key change in the MDR is that sufficient clinical data need to be presented for each product, clinical claim, and clinical indication. Under the EU’s previous device regulations, manufacturers often use a mix of data that was biased toward specific products, clinical claims, and/or clinical indications. The MDR provides that if no additional data are being generated for specific claims and indications, those claims and indications will need to be dropped.
Many companies have not been writing clinical evaluation reports in line with the MDR’s requirements or the associated guidance, Gos said. These companies will need to essentially start over and develop all-new procedures.
For example, in their quality management systems, manufacturers should include a process for writing clinical evaluation reports, along with criteria for deciding when clinical studies are needed and what they should focus on. A QMS also should include templates and guidance on how to write clinical evaluation plans and collect the appropriate data.
In addition, manufacturers should communicate early and often with their notified bodies to ensure that their clinical data will be accepted.
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