Toward the end of December 2022, the MDCG published a position paper aimed at providing a common understanding and approach to the application of Article 97 of the MDR. Giving some hope concerning devices that were certificated under the MDD but have expired since May 2021 or will expire before an MDR certificate is issued.
If a manufacturer can successfully apply for an exemption under Article 97 and continue to place devices on the EU market it will certainly be a huge relief, and it is envisaged that the exemption will last for 12 months which hopefully should be sufficient time certainly if the transition to the MDR is well on its way, otherwise, a second application or an extension may be necessary.
For those who wish to apply for an exemption using Article 97 we strongly recommend you thoroughly read the MDCG 2022-18 Position Paper on the Application of Article 97 to Legacy Devices. Pay particular attention to the annex of the Position Paper since this will lay out the criteria and documents required to evidence your claim for an exemption.
Competent Authorities are not suddenly going to have spare capacity to review your applications and grant exemptions and within a reasonable time frame so if this is a route you wish to take, please keep in mind that an exemption is not a formality, you will need to present your application in a clear and logical way and make sure the authorities can easily navigate the documents presented to them. If you don’t take the time to prepare your application in a clear methodical way, be prepared for your application to be rejected!
For those readers who have appointed Advena Ltd as their Authorised Representative, your application for an exemption must be submitted to the Malta Medicines Authority, if you need additional support with your application, please contact us at info@advena.mt
