This month`s MedTech news round up covers the Brexit impact on clinical studies, EC clarification on remote audits, FDA`s update on Electromagnetic Compatibility of medical devices draft guidance, MDCG guidance on IVDR classification, and the FDA`s latest device-specific performance criteria.
Brexit: UK sponsors running clinical studies in EU should appoint an Authorised or EU legal Representative
The UK`s departure from the European Union on January 1, 2021 will impact clinical investigations with medical devices, clinical performance studies with in vitro diagnostic devices, and clinical studies with medicinal products.
Brexit will mean that sponsors and patients may find themselves on different sides of a new EU outer border. Where the single market relies on one set of rules, different rules will apply for different markets.
UK-based sponsors performing studies in the EU are being urged to act now, by appointing an Authorised Representative or an EU legal representative as soon as possible. They may otherwise run the risk that their study could be halted or terminated and declared invalid in the Member States. Find out more here.
European Commission clarifies guidelines for medical device remote audits
The European Commission (EC) has published a new guidance document prepared by the Medical Device Coordination Group (MDCG) that aims to address disruptions to planned Notified Body physical audits caused by COVID-19 and the related travel restrictions.
The purpose of MDCG 2020-17: Questions and Answers related to MDCG 2020-4, is to expand upon the information initially published in MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance covers the provision of alternative audit methods when on-site inspections are considered unsafe, and the eligibility criteria and procedural considerations for conducting remote/virtual audits. Find out more here.
FDA extends comment period for Electromagnetic Compatibility of Medical Devices draft guidance
The FDA is extending the comment period for the draft guidance: “Electromagnetic Compatibility of Medical Devices” published on November 17, 2020, following a request for an extension to allow those interested additional time to submit comments.
Interested parties can submit either electronic or written comments on the draft guidance by February 16, 2021. Find out more here.
MDCG publishes classification guidance for IVDR
The Medical Device Coordination Group (MDCG) has published their IVD Classification guidance document for IVDR (MDCG 2020-16).
The purpose of the document is to provide guidance to manufacturers, notified bodies and healthcare providers on how IVDs should be classified before they are placed on the EU market (considering IVDR 2017/746).
The guidance is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.
A great deal of the guidance is dedicated to explaining seven rules for determining the classification of IVDs, and provides examples of diagnostics under each rule, including an annex that gives examples of how IVDs used in combination should be classified. Access the guidance here.
FDA posts final guidance on device-specific performance criteria
FDA has released three device-specific guidance documents detailing performance criteria and testing methodologies in support of its Safety and Performance Based Pathway.
The documents cover Spinal Plating Systems, Magnetic Resonance Receive-Only Coils, and Orthopaedic Non-Spinal Metallic Bone Screws and Washers.
The Safety and Performance Based Pathway guidance, published by the FDA last year, was created to set out a pathway that enables companies to show a new product is as safe and effective as a legally marketed device using FDA-identified performance criteria. Find out more about the latest device-specific guidance here.
That concludes this month`s update. Check back in January for more MedTech news.
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