Update on the New EU Medical Device Regulation and In Vitro Diagnostic Regulation
As part of this process, Eur-lex released the final draft of the amended MDR and IVDR on February 22, 2017. The drafts include instructions on the chemical requirements in the new regulations – in sections 10.4.1 and 10.4.5 of the draft MDR and section 10.3 in the draft IVDR. The MDR also contains special guidelines on phthalates and CMR or endocrine disruption substances.
The draft MDR also states that a label will be necessary if a device, part or material contains CMR 1A, 1B or EDCs in a concentration higher than 0.1% (w/w). In addition, instructions for use must be given as a precautionary measure if the device is intended for use by a patient group who may be considered particularly vulnerable to substances and/or materials within the device. The draft legislation singles out children and pregnant or breastfeeding women as vulnerable groups.
The full timetable, as released by Eudamed, is:
• End January 2017 – English version of the new MDR and IVDR
• Middle of February 2017 – English version and EU translations distributed to stakeholders
• Beginning of March 2017 – Council expected to accept the new versions
• Beginning of April 2017 – European Parliament adopts regulations
• End April 2017 – Formal publication
• End May 2017 – Official entry into force
• End May 2020 – MDR applicable
• End May 2022 – IVDR applicable
The revision and creation of a new European MDR and IVDR has been in discussion since 2012. It is expected that the official versions will enter into force in May 2017. This will create an applicable date of May 2020 for the new MDR, and 2022 for the new IVDR.
Stakeholders are advised to now consider the updated regulations to check their future compliance.
SGS Medical Devices Services
SGS’s medical device testing, certification, audit and training services help companies navigate the complexities of international medical device regulations to bring their products to market quickly whilst ensuring compliance with the required regulations and standards. Learn more about SGS’s Medical Devices Services (www.sgs.com/consumermedicaldevices)
SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full Eudamed Releases Timetable to Update the EU’s Medical Device Regulation and in Vitro Diagnostic Regulation SafeGuardS. (www.sgs.com/en/news/2017/03/safeguards-04517-eudamed-releases-timetable-to-update-the-eu-medical-device-regulation)
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For further information contact:
SGS Taiwan Ltd. Multi-Chemical Lab (Taipei) Asst. Manager
Tel: +886 2 22993279
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.
1, Mons Calpe
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