HPRA process for Article 97 and notified body certificates

News Category: Regulatory news

Date: 13/02/2023

In December 2022 the Medical Device Coordination Group published guidance (2022-18) on the use of Article 97 of the Medical Devices Regulation (MDR). The guidance allows for a controlled period of non-compliance for certain devices affected by the capacity challenges of notified bodies under specific conditions.

We have developed a process to use Article 97 for expiring or expired Directive certificates subject to meeting specific criteria. It will be used as a short-term measure to avoid disruption to the supply and availability of medical devices and healthcare in Ireland.

Irish-based manufacturers or authorised representatives who meet the criteria can submit a request form for each certificate affected and pay the relevant fee.

This process will be in place until the EU Commission’s proposed legislative amendment to Article 120 of the MDR is adopted.

For further information please see our dedicated page on the HPRA process for expiring device certificates.

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