EU Device Regulation Includes Premarket Scrutiny Mechanism, Industry Vows Pushback

As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that high-risk medical devices undergo more rigorous premarket scrutiny, but not on the level required by the U.S. Food and Drug Administration (FDA). The proposed regulations, unveiled Sept. 26, are already generating industry pushback over concerns they will delay marketing authorization of novel medical technologies.

Under the plan, which would combine the three existing directives on devices, active implantable medical devices and in vitro diagnostic devices into two EU-wide regulations on medical devices and IVDs, notified bodies would have to inform a newly created Medical Device Coordination Group (MDCG) when they receive a high-risk device application. The MDCG could then request that the notified body submit a preliminary assessment for review before issuing a certificate of approval.

The MDCG would have up to 60 days to complete its review. If concerns arose during the review, the MDCG could request additional information, including samples or an on-site visit to the manufacturing facility.

The premarket mechanism would add another layer of expert opinion, though the commission notes that its use “should be the exception rather than the rule.”

The additional scrutiny “will cause several months market entry delay to the products that are singled out…but time will tell what portion of high-risk, innovative and implantable devices will be covered under this extra review regime,” said Gert Bos, head of regulatory and clinical affairs for medical devices at BSI Healthcare, a UK-based notified body.

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