Please let us know where you are, or where you would like to be in the world so we can point you in the right direction.

Lloyd’s Register Quality Assurance (LRQA) announced on Wednesday 12th June that it will be withdrawing from its notified body (NB) services. LRQA’s customer experience director said that “following recent market developments and in the spirit of transparency, we have made the strategic business decision to exit from these services.”

As a result of their decision, LQRA advised clients to choose an alternative NB and to establish a team to help with the transition period to minimise the risk of disruption. LQRA will extend its notice period and provide 90 days’ notice rather than the required 30 days. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) expressed the urgency of transferring to an alternative NB.

Claire Ruggiero, LQRA’s customer experience director also confirmed that they will still provide third-party certification services that relate to ISO 13485 as well as the International Medical Device Regulators Forum’s Medical Device Single Audit Program (MDSAP). They will also continue to provide training to UK and worldwide clients on medical devices.

The number of concerns across the EU sector over implementing MDR and IVDR are rising and LRQA’s recent movements add to this uncertainty. Concerns have recently also been raised by the German and Irish delegation with the NB capacity under medical device regulation (MDR) so far. The only notified bodies to be under MDR so far are BSI UK and TÜV SÜD.

One solution to combat the lack of NBs under MDR is from the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) is to use MDSAP certificate to help offset the problem.

Uncertainty

Without an agreed Brexit, UK medical device companies are already uncertain as to their EU certifications. The UK notified bodies have been trying to make changes to combat impact from a “no deal” Brexit but only BSI and TUV have been able to offer any real security on this. This latest announcement from LRQA has been a further blow to the industry and further confusion to the medical device market.

Lack of support

The LRQA referred clients to use the other notified bodies: BSI and SGS. These companies however, are not taking on new clients.

Timing

It is 11 months until the MDR comes into force and now companies are not only having to contend with meeting the new regulations, they have 3 months to find a new notified body. LRQA said its services will cease regardless of whether the transfers are completed within the 90-day notice period.

Positivity

The medical market has faced challenges before with recertification and industry changes. Fortunately having some of the finest talent in the world means we have always survived.

Share

Find out how we can help you.

Get in touch Find out more