The European Commission has published a very comprehensive factsheet intended to support the legal manufacturers of Class I medical devices. Whilst the guidance is most welcome, and industry is humbly grateful, this publication now appears when the regulation goes into effect 28 Days Later (yes, reference to the zombie apocalypse film). Better late than never?
The EC factsheet provides clarity buried on page 3 item 2:
2. When do MDD Class I medical devices that remain as Class I under the MDR need to meet the requirements of the MDR?
Class I medical devices placed on the market under the MDD, that continue to be Class I under the MDR, will need to comply with MDR requirements as of 26 May 2021.
All Class I medical devices destined for the European market are required to guarantee compliance with all applicable requirements of MDR 2017/745 as of 26 May 2021. If a manufacturer of a Class I device (as per MDR classifications) already placed on the market was patiently waiting for this additional guidance prior to implementing internal processes, well it is a bit too late. European patients, hospitals, and healthcare workers should trust that astute regulatory teams have performed well within their organisations to facilitate these devices remaining available to provide foundational treatment and also to support life-enhancing therapies.
Since 2017, medical device manufacturer’s cross functional teams have been struggling to decipher the requirements, implement new processes, review/update documentation and source electronic tools, all essential to support continued regulatory compliance with MDR.
Compliance with the regulation for Class I medical devices will entail much more data exchange and collaboration between internal functions, external supply chain actors and regulatory authorities, with increasing volume and velocity. Device data, the company’s most valuable asset, needs special handling, care and security. Regulatory operations teams who have successfully manoeuvred through the myriad of requirements, should not be let down, so close to the finish line, by a lack of tools for data governance and management. Compliance with the MDR must be viewed by senior management as the opportunity to enhance capabilities of regulatory affairs which promotes a sustainable and scalable organisation.
Ensure your regulatory affairs operations have the support they need to keep Class I medical devices on the market.
EC Factsheet for Class I Medical Devices: https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_mdcg_2021_factsheet-cl1_en.pdf