On 20 August 2020, the European Commission issued regulations establishing Common Specifications for the reprocessing of single-use medical devices (SUDs) under the Medical Devices Regulation (MDR) (the “Common Specifications”). Common Specifications are a set of technical and/or clinical requirements, other than a standard, that provide a means of complying with the legal obligations applicable to a device, process or system. Details of what these Common Specifications entail can be found here.
The European Commission published the draft Common Specifications in July 2019. At the time, industry (particularly the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR)) expressed concern regarding the obligation imposed on reprocessors by Article 5 of the Draft Common Specifications to assess the suitability of the device for processing. Now that the Common Specifications have been published, it is clear that these concerns around Article 5 have not been fully addressed.
Article 5 appears to be based on the flawed premise that manufacturers of SUDs publish a great deal of technical information regarding their devices and that the reprocessor could use that information to assess the suitability of reprocessing. COCIR reminded the European Commission that such information is often confidential and so the manufacturer is not obliged to publish this information.
Among other things, a reprocessor must verify whether the device has been withdrawn or is subject to safety restrictions. The draft Common Specifications assumed that this information would be published by the original manufacturer of the device on its website. However, there is no such obligation on manufacturers. This issue is compounded by the unavailability of EUDAMED (the European Database on Medical Database), which should otherwise include this information.
While Article 5 of the Common Specifications has been amended slightly in light of the feedback from industry, the fundamental challenge regarding accessing confidential information remains.
It is worth noting that the MDR requires reprocessors to engage a notified body to certify compliance with the Common Specifications. We have written previously about the comparative lack of notified bodies that have been certified against the MDR and we note that notified bodies will be required to certify compliance with the Common Specifications solely on the basis of the a report carried out by the reprocessor’s external auditor.
Originally, the MDR provided for the common specifications for Annex XVI products without an intended medical purpose to be adopted by 26 May 2020. However, the date of application of the MDR has been delayed by the European Commission by 12 months until 26 May 2021. The European Commission cited concerns that “Member States, health institutions, economic operators and other relevant parties” will not be in a position to ensure proper implementation in light of the ongoing COVID-19 outbreak. It is worth noting that the European Commission’s implementation of the MDR was plagued by delays before COVID-19. The flagship IT database for medical devices (EUDAMED) was supposed to launch in May 2020, but will not, in fact, be ready before May 2022.
We await the common specifications for Annex XVI products, which were scheduled to be published by 26 May 2020. However, these are now not expected to be published before Q4 2020.