Article 97(1) request to Competent Authorities
Manufacturers, or their authorized representatives, should proactively inform their relevant Competent Authority about the upcoming or already incurred non-compliance with the MDR requirements. The request only needs to be made to that Competent Authority, and not to all the national Competent Authorities.
So that the Competent Authority can make a proper assessment, the manufacturer should submit a report containing relevant data gathered through its post-market surveillance system (PMS), in particular data related to incidents, serious incidents and/or field safety corrective actions.
The Competent Authority should take the following into account, when deciding if the device does or does not present an unacceptable risk to health and safety.
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- Review the above-provided information
- Additionally perform its own independent research
- Take into account information from the Notified Body, such as potential safety-related shortcomings identified during the last surveillance audit and their resolution
If the device is determined to not present an unacceptable risk to health and safety, then:
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- Legacy devices are subject to the Article 120(3) transition provision requirements, including compliance with post-market surveillance, vigilance and market surveillance
- Manufacturers of the eligible Article 97(1) products must further demonstrate that they have adapted their quality management system to the MDR requirements
Criteria and Documents
MDCG 2022-18 includes an Annex with a checklist of the criteria and documents to be provided. This starts on page 7.
The checklist notes which items are optional. For example, each Competent authority could request proof of registration of the device, in accordance with the national requirements. This could be proof of registration for a Class I sterile or measuring device, which must be performed by the manufacturer, or their authorized representative. It could also mean proof of registration for Class IIa, IIb and III/AIMDD devices. This is allowed per the Directives, which states that when the member state transposes the Directive into their national law, they can choose to require registration of those higher-risk devices being placed onto their markets.
If you are unsure which member state requires registration of these higher-risk devices, please refer to our tool: EU Registration Requirements