The European Commission’s (EC) Medical Device Coordination group (MDCG) has posted five new guidances on clinical evidence for legacy devices, regulatory requirements for ventilators, post-market clinical follow-up (PMCF) plan and evaluation report templates, and clinical evaluation of equivalence to existing devices.
The aim of the guidance for legacy devices is to explain to manufacturers and notified bodies how to generate sufficient clinical evidence to demonstrate conformity to the general safety and performance requirements for devices CE-marked under the old directives. The guidance also explains that compared to the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD), the incoming Medical Device Regulation (MDR) provides greater detail with respect to the process of clinical evaluation, including the consideration of alternative treatments, the benefit-risk ratio and the incorporation of post-market surveillance data. The guidance also states specific recommendations for conducting clinical evaluations for legacy devices under Annex XIV Part A of the MDR.
The guidance on regulatory requirements for ventilators and related accessories outlines different regulatory options to facilitate rapid approval of life-saving ventilator devices to market in response to the coronavirus pandemic. It explains the regulatory implications of various approaches to boosting the availability of ventilators, including guidance for companies supplying parts or finished devices to medical device manufacturers.
“In the exceptional COVID-19 context, the assessment procedures will ensure a short-term supply while guaranteeing patient safety. The Member State will evaluate the available technical documentation to find evidence that essential performance and safety requirements are guaranteed in the context of use.”
Two separate guidances on PMCF templates for plans and evaluation reports guide manufacturers and notified bodies by describing the requirements for developing these reports, and how they align with MDR.
Finally, in their clinical equivalence guidance, the MDCG explains that it is possible to use clinical data related to an equivalent device when performing a clinical evaluation during a conformity assessment. The guidance also explains the differences between the old directives and the MDR in technical, biological and clinical criteria for demonstrating equivalence.