The EU MDR and IVDR have a significant impact on your MedTech business. When the MDR was first published, many companies sought help investigating the effect. Manufacturers in Europe and around the world have CE-marked products on the market, but with the new European regulations in place, many are still struggling to get their devices and IVDs CE-marked under MDR. Over the last eight years, we have supported many customers in getting their products through conformity assessments with notified bodies. We now see that mainly the mid-size and smaller companies are still in that process (or haven’t even submitted their documentation for review) and need regulatory support in remediation of their technical documentation or support during submission reviews with notified bodies to answer questions that notified bodies have asked or resolve issued non-conformities.
What does the MDR mean for your business?
There are two possibilities. You either have developed a new product that must comply with stricter MDR or IVDR regulations compared to the MDD and IVDD, or you market a legacy product approved under the MD/IVDD. Legacy devices must undergo a new conformity assessment with a notified body. Lower risk classes are assessed based on sampling, meaning a file is picked from a product family. The technical documentation of many legacy devices does not comply with the stricter requirements of the MDR and IVDR. It needs reverse engineering, additional product verification testing, or validations to cover the gaps between the old and the new regulations. This takes time from R&D and regulatory resources, and money must be spent on additional testing and validations.
How to deal with MDR compliance
Regarding legacy devices, we always say: start early. You might think it will be an easy transition as you’ve already been certified before, but the requirements are much stricter this time. You may face surprises while covering the gaps in your technical documentation. Based on experience over the last year, Qserve follows a structured approach. After reviewing the technical documentation, we list the gaps against the MDR/IVDR and create a project plan outlining the reverse engineering process. This way, we ensure the design documentation is in place before we draw up the MDR/IVDR submission file. We advise our customers to follow this approach to avoid delays in the remediation of the technical documentation due to missing parts or failing tests. Design experts who can support during the reverse engineering process. The most urgent message is: start on time to avoid surprises, which may result in missing a submission deadline. Be fully prepared for when the transition period for class III and class IIb implantable devices ends at the end of 2027, considering that a review by a notified body, on average, takes 12 to 18 months. The clock is ticking...