Ever since manufacturers began scrambling to put in an application with their respective EU Competent Authority (CA) we have managed to assist our clients in obtaining a derogation for their legacy devices with respect to Article 97. In some cases, this was a relatively simple application whilst in others, we spent months’ worth of back and forth to get to a reasonable conclusion. Some are still ongoing. Here we wanted to share our experience to date on this process.
Article 97 covers a critical “backdoor” to the EU market which allows a Competent Authority of an EU Member State to issue a derogation against the requirements of the Regulation for a device that is non-compliant with the Regulation. However, this is a highly regulated process which requires the manufacturer to jump through several regulatory hoops within a defined timeframe. If the manufacturer fails to do so, they lose their access to the market.
For legacy devices struggling to meet the transition timeline of the MDR, Article 97 was an appropriate second chance. However, with the release of the new MDR Article extensions through Regulation (EU) 2023/607, this route became less significant, with the EU Medical Device Coordination Group (MDCG) even discouraging this route, as reported in our news item earlier this year. They argue that since legacy devices should now be using these new extensions, Article 97 has technically become obsolete.
However, there are of course manufacturers of devices which, for one reason or another, have ended up without a valid certificate. We have had clients who lost out on their Directive certificate renewal due to an administrative error at a Notified Body, which remains unsolved. For these important products left by the wayside, Article 97 is possibly their best bet.
Article 97: Required Information / Documentation #
With that said, Article 97 has become a notoriously difficult path to walk, and over time, we have seen more requirements being demanded of the manufacturer. If you are preparing for an Article 97 application, we have prepared the following list of information which may be asked of you:
- Most recent Declaration of Conformity.
- Notified Body agreement.
- Notified Body Confirmation Letter.
- Indication of the countries in which the device shall be marketed.
- The latest audit reports relevant to the device in question.
- An indication of any changes made to the device or intended purpose since 26 May 2021.
- A statement of commitment for the continuous application of MDR requirements with respect to post-market surveillance, vigilance, registration, and vigilance.
- Labelling and Instructions for Use.
- Demonstratable evidence that the manufacturer is actively transitioning to the EU Regulations.
Should you need any assistance in applying for Article 97 with your Competent Authority, get in touch for a quick chat and we’ll point you in the right direction.