Handling of Certification Gaps according to MDCG 2022-18

The Medical Device Coordination Group (MDCG) has released a new document that provides guidance on handling certification gaps for medical devices in the EU/EEA. The document, MDCG 2022-18, addresses the procedures for handling certification gaps for medical devices in the EU/EEA and provides guidance on market surveillance procedures for member states...

Overview: Handling of Certification Gaps according to MDCG 2022-18 in Switzerland

MDCG 2022-18 outlines the procedures for handling certification gaps for medical devices in the EU/EEA. The document provides guidance on the steps that should be taken by member states to ensure that medical devices are safe and effective. It also addresses the procedures for market surveillance and the measures that should be taken by market surveillance authorities in the event of a certification gap.

Reliance on MDCG 2022-18 Confirmations of EU/EEA Member States

MDCG 2022-18 also provides guidance on the reliance on confirmations of EU/EEA member states. The document states that member states should rely on the confirmations of other EU/EEA member states when assessing the safety and effectiveness of medical devices. This helps to ensure that medical devices are safe and effective

Market Surveillance Procedures according to MDCG 2022-18 in Switzerland

MDCG 2022-18 also provides guidance on market surveillance procedures for member states. In Switzerland, the procedure for market surveillance is outlined in the document, including the steps that should be taken by market surveillance authorities in the event of a certification gap.

Surveillance and Measures by Swiss Market Surveillance Authorities

The document also addresses the surveillance and measures that should be taken by market surveillance authorities in Switzerland. This includes procedures for monitoring the market for medical devices and taking appropriate measures in the event of a certification gap.

Free Sales Certificates

MDCG 2022-18 also provides guidance on the issuance of free sales certificates for medical devices. This includes the conditions that must be met for a device to qualify for a free sales certificate and the procedures for issuing the certificate.

Frequently Asked Questions

The document also includes a section with frequently asked questions about the handling of certification gaps for medical devices in the EU/EEA. This provides additional information and clarification on the procedures outlined in the document.

You can download the document here.

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