The “Opt-In” Provision of the EU MDR (Article 17):

  • Undermines EU Law and the Single Market
  • Deprives Hospitals of Sustainable Medical Device Options, and
  • Exacerbates Shortages in the Healthcare Supply Chain

The time has come to change it.

Summary

Health systems are under enormous pressure. Urgently needed amendments to Article 17 of the EU Medical Device Regulation (MDR) would help:

  • Alleviate supply chain disruptions – these were laid bare during the pandemic and remain critical for some medical devices;
  • Reduce the surprisingly high environmental toll and costs generated by healthcare;
  • Promote more innovative and competitive medical devices;
  • Advance the Commission’s and Parliament’s desire to remove EU regulatory barriers that impede circular economy solutions, such as device remanufacturing; and
  • Address changed political circumstances since the original passage of the EU MDR.

The Association of Medical Device Reprocessors (AMDR), the trade association representing regulated, commercial medical device reprocessing and remanufacturing companies urges Article 17 be amended to:

  • Remove the illegal regulatory barrier (portion of 17.1) restricting the sale of CE-marked remanufactured devices on the whole of Europe to state: “17.1 Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article;”
  • Amend Art. 17.3 to instruct the Commission to provide guidance back to Member States on their requirements in overseeing Common Specification (CS) reprocessing by hospitals and third parties, to ensure that Member States that allow CS reprocessing must also allow CE reprocessing.
  • In the absence of any Notified Bodies willing to certify 17.5 described reprocessing, we propose to amend the section to require hospitals or commercial reprocessors seeking to reprocess according to the Common Specifications, to be required to demonstrate conformance with the internationally accepted standards: ISO 13485 Quality Management Systems, ISO 14971 on Risk Management, ISO 60601 on Medical Electrical Equipment and ISO 10993 on Biocompatibility.
  • Remove the needless and restrictive 17.6 provision; and
  • Remove the regulatory barrier (17.9) that allows Member States to impose, without medical or scientific justification, a higher standard for reprocessed devices than for any other medical device.

Click here to read the full position paper.