What if we can’t get our EU MDR certificate in time?
We are all aware that notified bodies are struggling for resource to meet their obligations under the EU MDR and that, in 2023/2024, a huge number of medical devices need to progress through their conformity assessments before all MDD certificates are withdrawn. The MDCG published a position paper in August 2022 with steps to help improve notified body capacity, but for many manufacturers, whose certificates are expiring imminently, MDCG-2022-14 and any further publications in the future may come too late.
If you’re a manufacturer whose MDD certificate is expiring, what are your options?
1.Build stock and place it on the EU market whilst your MDD certificate is still valid
If time and finances allow, this option will ensure your continuity of supply for a finite period. Note that if you’re not in the EU, you must have either manufactured, released and sold the product to an EU entity by MDD expiry, or the product must be physically in the EU.
2. Apply for a derogation from conformity assessment as detailed in MDR Article 59
A derogation (exemption) can be requested from each Member State where you wish to place product on the market. Each Member State may require additional steps that the manufacturer and other economic operators in the supply chain will need to comply with. This route is not currently being readily accepted (reference MDCG-2022-11), but perhaps the stance will change in future, as more manufacturers are affected. There is no centralised approach for this so If you’re going to try this route, start with your lead competent authority and involve your EU Authorised Representative.
3. Request for Member States to follow MDR articles 94 and 97
Whilst these articles will not have been written with this intent, by using them as a potential legal route to continue to place product on the market in the EU, Article 94 allows for Member States to perform a review of devices, which do not comply to the MDR (i.e. have not completed conformity assessment) and perform a review (Article 97) of the risk to the health and safety of patients, users or other persons, or to other aspects of the protection of public health. Member States will require the manufacturer to bring the non-compliance concerned to an end within a reasonable period, but this maybe enough time to secure an MDR certificate. As with derogations, this is not a centralised route, so start with your lead competent authority first, in conjunction with your EU Authorised Representative. If you’ve had success using this route, we’d love to hear from you.
4. Don’t necessarily write off your UK sales
Can you achieve certification to the UK MDR faster than to the EU MDR? If you can, then you may have labelling updates to make (removal of CE and addition of the UKCA), but this may be a route that can keep companies going through a gap in their EU certification. UKCA marking under current UK legislation becomes a requirement for devices placed on the market in England, Scotland and Wales after the 30th June 2023, so manufacturers are urged not to delay this process.
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Or if you need to appoint a UKRP, please give us a call on 01925 724286 or drop us an email at firstname.lastname@example.org, and we will be delighted to help you.
RA & Clinical Consultant