With less than a year until the end of the EU MDR transition period, it is pertinent to ensure that all devices to be sold in Europe comply. We’ve been highlighting many of the new requirements in our blogs, including:
INTRODUCTION TO CLINICAL EVALUATION REPORTS (CERS),
TRANSITIONING TO THE EU MDR? DO YOU HAVE A PRRC YET?
WHAT THE NEW EU MDR MEANS TO YOUR REVENUE
DO YOU KNOW WHAT YOUR TECH FILE SHOULD INCLUDE?
Prior to the MDR, there was no single European standard or regulation for single-use device (SUD) reprocessing, but now those who reprocess SUDs are being held to the same obligations as manufacturers. This update does not allow SUDs to be reprocessed across Europe as each nation’s law must permit and regulate it. Article 17 outlines the requirements specific to SUDs.1
Often, healthcare institutions may reprocess SUDs as a cost reducing initiative. If this is the case, EU Member States will be allowed to apply their own rules so long as they ensure equivalent safety and performance and adhere to the common specifications regarding risk management, validation, testing, quality management systems, incident reporting, and traceability.1
While each Member State is allowed to regulate SUDs themselves, the EU MDR is very specific on what SUDs can be reprocessed and the standards each reprocessed device shall meet. Keeping with the theme of the rest of the MDR, patient safety is at the forefront of SUD reprocessing regulations. Only devices on the market in accordance with the MDR and/or Directive 93/42/EEC and deemed safe through scientific evidence will be allowed to be reprocessed. Additionally, the label will have to be updated to include the fact that it was reprocessed and remove the original manufacturers’ information, which shall be included in the instructions.1
If you are currently reprocessing SUDs, but need help ensuring you are compliant with the updated regulations, reach out to us at 248-987-4497 or email info@emmainternational.com.
1 Official Journal of the European Union – REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL retrieved on 06/14/2019 from https://eur-lex.europa.eu/legal-content/ENG/TXT/PDF/?uri=CELEX:32017R0745&from=EN.
