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 (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;”
- Strike 17.6, which needlessly restricts access to raw materials. It applies only to 17.3 and 4 CS products as manufacturers, including remanufactures, must prove product safety and efficacy of their products to obtain a CE mark.
- Consistent with 17.1, remove the regulatory barrier (17.9 in its entirety) 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.