Industry Criticizes EC’s Specifications for Reprocessing Single-use Devices under EU MDR
Posted 21 August 2019 | By
The European Commission’s (EC) draft implementing act on the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR) received criticism in newly posted comments from industry groups.
The comments raise issues and concerns with many of the provisions that the draft implementing act for common specifications (CS) on single-use devices set forth
in July. The draft implementing act is the second implementing act to be issued in accordance with the EU’s 2017 legislation, with the only implementing regulation adopted so far being one on notified bodies
The issues and concerns commenters raised with the single-use device act range from a lack of legal basis to implement some of the requirements to a lack of clarity around expectations for manufacturers, with several commenters going so far as to call on the EC to delete various provisions.
A shared concern across most commenters relates to the provisions of Article 5, particularly for the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR). COCIR points to Article 5.3 as well as 5.3(b) and 5.3(c) in stating that “there is no legal obligation” or “legal basis” for the rules such provisions would create. The rules concern health institutions’ access to manufacturers’ technical documentation and communicating the information on manufacturers’ websites.
Article 5 Questions
Other commenters taking issue with manufacturers’ obligations include MedTech Europe, the Association of Medical Device Reprocessors (AMDR), Qualitas Professional Services, the German Society for Sterile Supply (DGSV), the German Hospital Federation (DKG), Olympus and MEDITREAT GmbH.
Those requesting that Article 5 be deleted argue not only that some provisions are lacking legal basis but that they extend beyond the requirements of Article 17(3) of MDR and are thus redundant. Oliver Bisazza, director of regulations and industrial policy at MedTech Europe, notes that manufacturers’ technical documentation is proprietary information in arguing against mandating this be made publicly available.
DKG argues that Article 5 “is superfluous and has to be deleted.” The hospital federation also says that the CS “is clearly an attempt to indirectly ban the reprocessing of ‘single-use’ medical devices by imposing such high requirements that health institution cannot meet them.”
Other recommendations on Article 5 offer alternatives to deletion. COCIR recommends revising some provisions of Article 5 to require verification that a single-use device has not been withdrawn from Eudamed and “is not subject to restrictions for safety reasons” and clarifying others. Bisazza echoes COCIR’s recommendation for further clarification and proposes “for the health institution to request access to the manufacturer’s rationale as to why the device was qualified as being for single use only.”
Yet Article 5 is not the only Article in the draft implementing act that is being subject to calls for deletion. Commenters also note redundancy with MDR in pushing against Articles 2, 3, 4, 6, 7, 10, 12, 13, 14, 15 ,16, 17, 18, 19, 20, 21, 23 and 25.
German device reprocessor MEDITREAT GmbH also took issue with the tight deadline for the implementing act, which takes effect on the same day as MDR—26 May 2020. But the company says it needs a transition period of a year or more.