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

EUROPE

MDCG 2022-14 – Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

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).

MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies

The guidance is intended to bring consistency and to align the working practices of the different designating authorities in the Member States, regarding the assessment, designation, notification and re-assessment of CABs and NBs. The processes for assessment, designation and notification are established by Articles 38 to 42 of Regulation (EU) 2017/745 and Articles 34 to 38 of Regulation (EU) 2017/746, the in vitro Diagnostic Medical Devices Regulation – IVDR).

IRELAND (HPRA)

European Commission launches public consultation – reclassification of certain active products (including aesthetic products) without a medical purpose

The European Commission is inviting stakeholders to give their feedback on a draft implementing regulation laying down the rules for the reclassification of certain active products without a medical purpose. The consultation opened on 11 August 2022 and will run until 08 September 2022 (midnight Brussels time) and is available on the Commission’s webpage.

European Commission publishes call for European Union Reference Laboratories for IVDs designation

The European Commission has opened its call for Member States to submit applications on behalf of candidate EU Reference Laboratories for IVDs (EURLs). EURLs will play an important role in batch testing and verifying the performance of high-risk (Class D) in vitro diagnostic medical devices (IVDs).

USA (FDA)

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

This guidance document identifies applicable legal requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs).

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

FDA issued an updated guidance on the “Replacement Reagent and Instrument Family Policy” for in vitro diagnostic (IVD) devices.

This guidance is intended to update and provide clarity on the Replacement Reagent and Instrument Family Policy for manufacturers of IVD devices and FDA staff to promote consistent application of the concepts in this guidance.

CANADA (HC)

Health Canada will continue to issue electronic manufacturer’s certificate to export

Health Canada launched a pilot project to implement an electronic version of the manufacturer’s certificate to export (eMCE). The intent is to replace the paper-based process once the project is complete.

NEW ZEALAND (MEDSAFE)