MDR updates safety, clinical performance requirement for high-risk devices
- The European Commission's Medical Device Coordination Group (MDCG) has updated Medical Device Regulation (MDR) guidance aimed at manufacturers and notified bodies that work with implantable and Class III devices.
- Under the MDR, which went into effect on May 26, 2021, devices are divided into four classes that are ranked according to risk, from Class I for the lowest-risk devices to Class III for the highest. MDCG's latest guidance this month, which was first released in 2019, covers the MDR requirement for manufacturers to draw up a summary of safety and clinical performance for their implantable and Class III devices for validation by a notified body.
- The updated guidance has a new paragraph detailing the requirement for manufacturers to assign a unique reference number to the summary in their management systems. The summary "is one of several means intended to fulfill the objectives of the Medical Device Regulation to enhance transparency and provide adequate access to information," according to the MDCG.
MDCG, which advises the European Commission on medical device matters, created the 2019 guidance to help manufacturers and notified bodies comply with a transparency provision of MDR. By requiring the creation, validation and publication of summaries of safety and clinical performance (SSCP), MDR seeks to provide healthcare professionals and patients with "an important source of information" on the performance of high-risk medical devices.
The first revision of the guide retains all of the information provided in 2019. The main changes are the addition of a new paragraph on reference numbers and a related update to a summary template.
MDCG's additional paragraph states: "The manufacturer will assign to the SSCP an identifier (reference number) that within the manufacturer's management system is unique to that SSCP and will remain the same for the entire lifetime of the SCP. In combination with the manufacturer's (single registration number) this will allow for the unique identification of the SSCP in EUDAMED and in EU."
The updated template features "manufacturer’s reference number for the SSCP" at the top of the list of elements MDCG recommends manufacturers include in their summaries. The rest of the list is the same as the 2019 guide. MDCG also revised another section so it states the summary can be associated with one or multiple basic unique device identification - device identifiers (UDI-DIs). The 2019 guide states the SSCP is "associated to one unique Basic UDI-DI."
MDCG's update comes against a backdrop of continued debate about the implementation of MDR. Earlier this month, medtech trade groups in France and Germany, whose members make up more than half of the EU market, called for an extension of the MDR transition period to avoid a "collapse in patient care." The trade groups called for a two-year extension for the Class III and implantable products covered by the MDCG guide, plus a four-year delay for all other products.