Devicemakers Should Focus on EU Post-Marketing Requirements
To comply with the EU’s new regulations for devices and IVDs, companies should first look at their postmarketing clinical requirements to meet the May 26, 2020 deadline for devices and the May 26, 2022 deadline for IVDs, say Sidley Austin attorneys.
Surveillance systems must include a post-market follow-up to update clinical evaluations. Makers of Class III devices and implantable devices will need to develop a safety and clinical performance summary to be validated by a notified body that also will be made public.
Companies can expect enhanced scrutiny and surveillance, the law firm warns in a client update, noting that all notified bodies will be re-designated and required to have documented procedures regarding unannounced on-site audits of manufacturers and, when applicable, subcontractors and suppliers.
Previously, clinical data for new devices have been drawn mainly from available literature for equivalent or partially equivalent devices. By contrast, the Medical Device Regulation requires manufacturers to perform their own clinical evaluations for higher-risk Class III and implantable products.