At least one device trade association has expressed concerns about the length of the technical documentation required, delays in scheduling of audits, resource constraints and expected bottlenecks. The association argues that the solutions may lie in remote audits, use of a single audit program and providing more flexibility to the notified bodies. Hybrid audits, leveraging evidence from previous assessments and combining audits for legacy devices are all being discussed as possible solutions. All parties are being encouraged to foster capacity-building.

A few years ago, Health Canada and manufacturers doing business in Canada faced an analogous situation during the transition to a medical device single audit program (“MDSAP”). Perhaps some lessons may be garnered from the Health Canada experience.


For the noncompliant manufacturers (reportedly less than 1000) who had not submitted evidence of a transition to MDSAP by the 2019 deadline, most were eventually able to comply with few reports of nonconforming products being released — though there were some. Health Canada also, according to a press report, softened some requirements for smaller manufacturers. Maybe our Canadian regulatory friends can offer some helpful pointers to those ensuring the EU regulatory cliff walk goes smoothly.

About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.

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