MDCG posts five new guidances
The European Commission’s Medical Device Coordination Group (MDCG) on Friday posted five new guidances on demonstrating equivalence to existing devices; clinical evidence for legacy devices; templates for postmarket clinical follow-up plans and evaluation reports; and regulatory requirements for ventilators.Equivalence
Under the EU Medical Devices Regulation (MDR), it is possible to use clinical data related to an “equivalent device” in the clinical evaluation that occurs during a conformity assessment.
The MDCG explains that while the MEDDEV 2.7/1 rev. 4 guidelines on clinical evaluation of medical devices under directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD) should be referenced when demonstrating equivalence under MDR, the previous guidelines “are not fully aligned with the MDR.”
Thus, MDCG says the aim of the new guidance is to explain the differences in technical, biological and clinical criteria for demonstrating equivalence between the two regulatory schemes.
Legacy devices
The aim of the new guidance on legacy devices is to explain how to generate sufficient clinical evidence to demonstrate conformity to the relevant general safety and performance requirements (GSPR) for legacy devices CE marked in accordance with the MDD and AIMDD.
The guidance explains that sufficient clinical evidence “the present result of the qualified assessment which has reached the conclusion that the device is safe and achieves the intended benefits,” and that the clinical evaluation is part of a lifecycle approach and should be done on a continuous basis.
The guidance also explains that compared to the MDD and AIMDD, the MDR “provides greater detail and additional requirements with respect to the process of clinical evaluation,” including the consideration of alternative treatments, the acceptability of the benefit-risk ratio and the incorporation of postmarket surveillance data into the clinical evaluation.
The guidance goes on to provide specific recommendations for conducting clinical evaluations for legacy devices under Annex XIV Part A of the MDR.
Postmarket clinical follow-up (PMCF) templates
In two separate guidances, the MDCG provides templates for postmarket clinical follow-up plans and evaluation reports.
The guidances explain that the PMCF is “a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s postmarket surveillance plan.” The MDR also includes specific requirements for developing PMCF plans and evaluation reports.
Ventilators
In its guidance on ventilators and related accessories, the MDCG explains different regulatory options for bringing devices to market to facilitate the swift entry of the much-needed devices amid the coronavirus disease (COVID-19) pandemic.
Specifically, the guidance explains the regulatory implications for various approaches to boosting the availability of ventilators, including for companies supplying parts or finished devices to medical device manufacturers and companies looking to place new ventilators on the market.
The guidance also explains that under the amendment to delay the application of the Medical Devices Regulation (MDR) passed last week, member states may adopt derogations from other member states to authorize the marketing of devices that have not completed a conformity assessment.
“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,” the MDCG writes.
MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies
MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories