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Commission publishes report on reprocessing of SUDs

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission has published its Final Report following the ‘Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market.’ The authors comment that:

“This report presents an overview of national decisions regarding the reprocessing of SUDs [single use devices] in the countries studied (ranging from permitted to prohibited to no decision taken at all). The study also reports on the certification processes for SUDs by notified bodies, the reprocessing of SUDs by manufacturers and health institutions and the reuse of purchased reprocessed SUDs by health institutions. Perceived challenges and opportunities as well as actions recommended by stakeholders are included as well. The report closes with a series of conclusions and recommendations for optimising the implementation of Article 17 MDR in Europe.”

As a reminder, under the MDR, the reprocessing of SUDs may only take place where permitted by national law and in accordance with MDR Article 17, with two reprocessing options: (1) any natural or legal person who reprocesses a SUD must be considered to be the manufacturer of the reprocessed device and must assume the obligations incumbent on manufacturers; (2) any health institution (HI) that reprocesses and uses a SUD in-house must comply with common specifications (CS).

Three main study questions were addressed: (1) what is the current situation in the EU for reprocessing of SUDs?; (2) which obstacles and challenges might affect the reprocessing of SUDs in the EU?; (3) which possible solutions and recommendations could be used to address potentially identified issues?

The report indicates that 17 out of 30 countries (Austria, Bulgaria, Cyprus, the Czech Republic, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Liechtenstein, Lithuania, Malta, Norway, Romania, Slovakia) do not allow reprocessing, while 10 out of 30 countries: (Belgium, Croatia, Denmark, Germany, Iceland, Ireland, the Netherlands, Poland, Spain, Sweden) allow the reprocessing of SUDs. Only 3 countries (Luxembourg, Portugal, Slovenia) have not made a decision yet, due to the “divergent opinions of stakeholders and bureaucratic issues”.

Six out of 38 NBs designated under the MDR surveyed responded that they certify reprocessed SUDs or the reprocessing of SUDs. Only two NBs replied that they have received applications for the certification of reprocessed SUDs, however no certificates for a reprocessed device have yet been issued.

The report incudes a ‘Recommendation’ chapter, in which the recommendations are divided into five areas:

  • General recommendations
  • Legal framework and guidance
  • Certification
  • Implementation in member states
  • Product-related recommendations

Copies of the report can be obtained from here.