Warning….no more extensions…we expect you to comply!! (MDCG 2022-11)
Written By: Mark Swanson, Partner
Last month (June 2022) saw the Medical Device Coordination Group (MDCG) issue a short (only 2 pages) position paper to remind manufacturers of their need to be diligent about meeting the requirements of the European Medical Device Regulation (EU MDR).
As we all know, industry has been pushing for continued extension of the deadlines within the regulation for transition due to the burden on the manufacturers (particularly for clinical evidence and need for proactive post-market surveillance). There is time needed to adjust to these requirements.
With this position paper, the representatives of the members states and the chair from the EU Commission are setting out their position that enough time has been given and although around 70% of the certificates to place product on the market (under AIMDD/MDD) will expire in 2024, the manufacturers that are simply waiting and expecting to use derogation or get extensions will not be accommodated.
In fact, they specifically outline the expectation that manufacturers have submitted their application for certification to the EU MDR at least one year before their expiry of their AIMDD/MDD certificate. For many this "one year before" falls early in 2023 - next year. They further urge manufacturers to submit complete and compliant applications as soon as possible to avoid medical device shortages and timely compliance.
In other words, if you haven’t planned your transition this year your excuses are running out...
If all this seems daunting, QRx Partners can guide and support your efforts with your transition. Contact us at Contact@QRxPartners.com or 833-779-7278.
Find this MDCG guidance and other ongoing work here: Guidance - MDCG endorsed documents and other guidance (europa.eu)