August 3, 2022 Regulatory Updates
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Medical Devices – USA/Europe Regulatory Updates Roundup, July 2022

EUROPE (EU)

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)


This scientific opinion reflects the views of independent experts (MDR Article 106) on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices (MDR Article 54 and Annex IX, Section 5.1).

AEMPS-affiliated notified body becomes first Spanish group designated under MDR

A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under the EU Medical Device Regulation (MDR).

MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)

The Document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746

The European Commission has adopted common specifications for several types of high-risk diagnostics, such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.

New Notified body MDR NB 0318

New MDR Notified body has been approved. Please check the link below

USA (FDA)

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

The Food and Drug Administration has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products.

CANADA (HC)

Health Canada is modernizing and transforming the Medical Devices Compliance Program

The Medical Devices and Compliance Program require manufacturers and importers to report shortages and discontinuations that could lead to a shortage of medical devices on the List of Medical Devices – Notification of Shortages.
The program has streamlined and automated initial screening of annual licence review applications. It has also shifted from paper-based to electronic processes. The program launched a pilot project to implement an electronic version of the Manufacturer’s Certificate to Export.

Update: Application Form For a New Class IV Medical Device License

Health Canada updated application form for a new class IV medical device license.

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