Regulation (EU) 2023/607, ammending the MDR, allows more time for the notified bodies to certify their companies. However, manufacturer must have entered an application with a notified body by 26 May 2024 in order to keep the legacy status of their devices. For companies that are still looking for a notified body, it is the highest time to find the right notified body.
Companies should ensure they are sufficiently ready to face the first level of scrutiny by a notified body by the time they reach out. Perfection is not yet necessary, but one should be close. For first-time companies this can be intimidating and they may appreciate guidance and confirmation from an expert.
Boumans Regulatory Consulting can help companies profile themselves, taking into account their future plans, and match that profile with the profiles of notified bodies. There are some well known notified bodies, but there may be others that could be a better match for the company. Making a successful match involves more than checking notified body designation codes.
In a next step the company must reach out to notified bodies. Although they all have their standard procedure for inquiries, there is still some bandwidth to make a difference during the first impression. Then there are follow up calls, further exchange of information. All that communication must be done with the bigger picture in mind, resulting in a consistent and clear message to the notified body. Here too, support from an expert helps.
If you want expert support connecting with a notified body, Boumans Regulatory Consulting can help. Just reach out for a first call in which we can assess where you stand and what could be a good strategy to ensure you can keep placing devices on the Union market after 26 May 2024.