Our June MedTech news round up includes an update on the EU-Swiss MRA, the latest guidance documents from the FDA on testing & labelling for the MR environment, post-approval studies and postmarket surveillance, and updates from the EU Commission on medical device safety and eIFU’s. For this and more, read on below.
Status update: EU-Swiss Mutual Recognition Agreement for Medical Devices
The EU Commission has communicated that the mutual recognition and related trade facilitating effects for medical devices between the EU and Switzerland ceased to apply on 26 May. This is linked to the new Medical Devices Regulation that entered force in the EU on the same date. For more information click here. And for a closer look at how this will impact medical devices trade between Switzerland and the European Union read our recent topical article here.
Testing & labelling devices for the Magnetic Resonance (MR) environment: FDA issues final guidance
The FDA has published final guidance that provides their recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) environment, and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labelling. Access the guidance here.
FDA draft guidance published on Post-Approval Studies
PMA (premarket approval) by the FDA’s CDRH is a multi-step process that evaluates whether reasonable assurance of device safety and effectiveness has been demonstrated. A post-approval study (PAS) is sometimes required to provide this reasonable or continued assurance. A PAS is usually a clinical or non-clinical study that gathers specific data to address questions about an approved medical device’s postmarket performance / experience.
The FDA has published draft guidance covering the PAS requirements imposed as a condition of PMA approval. Find out more here, and submit comments on the draft guidance by 26 July.
EU commission publishes new Q&A on medical device safety
The EU commission has published a Questions & Answers on the Application of Regulation on Medical Devices MDR 2017/745 – EU rules to ensure the safety of medical devices. The Q&A includes the reasons behind the new rules on medical devices, how patients will benefit from the new regulation, products that will be affected by the new directive, the rules for different types of devices, the role of notified bodies and the state of play regarding EUDAMED. Find out more here.
FDA Postmarket Surveillance draft guidance open for comments
Section 522 of the FD&C Act requires manufacturers to conduct postmarket surveillance for certain Class II or III devices at the time of approval or clearance or at any time following. Postmarket surveillance is “the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device”, and data is collected to help address public health questions on the safety and effectiveness of a device.
This draft guidance document on postmarket surveillance from the FDA aims to assist manufacturers of devices subject to section 522 postmarket surveillance orders (522 orders) and is open for comments until 26 July.
Draft EU Commission Regulation: Rules for electronic instructions for use (eIFUs)
The EU Commission has drafted a Commission Implementing Regulation that lays down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council regarding the electronic instructions for use of medical devices. Find out more here.
FDA Workshop: Spinal Device Clinical Review
The FDA will hold a virtual public workshop entitled “Spinal Device Clinical Review” on 17 September, between 9am – 4pm ET. Intended for members of the orthopaedic community, device manufacturers, regulatory affairs professionals, clinicians, patients and the general public, the workshop aims to enhance understanding of the FDA’s approach to the clinical review of spinal devices falling under 21 CFR Part 888. For more information about the workshop, click here.
Useful resources from the MDCG
The Medical Device Coordination Group has recently published a variety of useful resources regarding UDI implementation, Implant Card guidance, EMDN, and Class I medical devices. Access the information below:
That concludes our June MedTech news. Check back in July for more updates.
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