EC Offers Specifications for Reprocessing Single-use Devices Under MDR

Regulatory NewsRegulatory News | 25 July 2019 |  By 

 The European Commission (EC) on Tuesday set forth the common specifications (CS) for the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR).
The EC is proposing the CS via a draft implementing regulation to specify requirements for the reprocessing of single-use medical devices in alignment with criteria in Article 17(3) of MDR.
EU member states may choose not to apply rules relevant to manufacturers’ obligations for single-use devices reprocessed and reused within health institutions provided that the safety and performance profile of the reprocessed device is equivalent to that of the original device and that the reprocessing is performed in accordance with the CS. MDR also allows member states to elect to apply such rules for an external reprocessor to reprocess single-use devices at the request of a health institution subject to both of these criteria from Article 17(3). The new implementing regulation will instruct on how to meet the criteria through compliance with the CS.
The implementing regulation addresses the CS across five different chapters. The first chapter offers two definitions to distinguish the term “reprocessor” from the term “external reprocessor” and the second chapter covers risk management.
The EC points to devices incorporating medicinal substances and implantable devices, among other device types, in noting that not all single-use devices are suitable for reprocessing.
“It is therefore necessary to determine the characteristics of single-use devices to be taken into account within risk management procedures, so as to ensure the exclusion of those single-use devices that cannot safely be reprocessed,” the EC states. CS concerning risk management should include the procedure established for the reprocessing process, which should be based on device characteristics and assessment results, according to the implementing act.
Chapters III through V address reprocessing procedures, quality management systems and traceability. A remaining chapter establishes when the regulation will enter into force, with the same 26 May 2020 date of application as MDR. Relevant harmonized standards and national provisions would take the place of the CS if the CS are not adopted by the date of application.
The EC initiated the process for harmonization of standards under MDR and the in vitro diagnostic regulation (IVDR), which will apply from 26 May 2022, just last month. The release of the implementing regulation comes ahead of the target in the MDR/IVDR rolling plan of essential implementing acts and actions. But the draft standardization request was met with criticism.
The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) argues in a position paper that “unfortunately, the proposed draft standardisation request still includes several elements that prevent flexible harmonisation and timely reference of standards in the Official Journal.” COCIR, which urged for harmonization of standards in April, is recommending that the request be rejected if adopted in its current form.
Single-use medical devices - safety and performance requirements for reprocessing


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