Lloyd’s Register Quality Assurance will stop providing medical device and in-vitro diagnostic notified body services, leaving the U.K. with three medical device and IVD notified bodies at a time when there are major concerns about whether the sector can meet demand created by European regulations coming into effect.
In addition to LRQA, European records show eight other medical device notified bodies that used to operate in the U.K. but have withdrawn their authorizations or allowed them to expire.
- LRQA will not apply to be a notified body for the new medical device and IVD regulations, nor will it push ahead with plans to mitigate the potential fallout from Brexit by establishing a presence in the Netherlands.
The exit comes as industry and politicians are growing increasingly alarmed about notified body capacity constraints ahead of the full implementation of European medical device and IVD regulations next year. While LRQA was yet to be designated under the new device regulation, its prior commitment to remaining a major notified body suggested it would be designated at some point.
Now, it will join the list of former medical device notified bodies.
While only two notified bodies, BSI UK and TÜV SÜD, are currently designated against the incoming device regulation, the EU has pointed to the 38 applications received as of April to show that more capacity will come online soon.
In a recent update, LRQA said it was “firmly committed to remaining a major” EU medical device notified body. However, after meeting with Dutch authorities in March, LRQA also warned its was unlikely to be established as a notified body in the Netherlands before 2020. If the U.K. leaves the European Union without a deal at the end of October, CE certificates issued by LRQA will no longer be valid in the remaining 27 member states.
With leading candidates in the race to be the next U.K. prime minister presenting a no-deal exit as a valid option, there is a real chance that companies that stick with LRQA will lose access to the EU market. Rather than try to salvage the situation, LRQA has opted to exit the market.
"Following recent market developments, we have made the strategic business decision to exit from these services," LRQA wrote in a statement. "We are working closely with the UK Medicines and Healthcare products Regulatory Agency to help customers which hold certification for these directives with Lloyd’s Register transfer to an alternative service provider."
The decision will leave the U.K. with three medical device and IVD notified bodies: BSI Assurance UK, SGS United Kingdom and UL International. BSI also has a presence in the Netherlands.
European records list eight medical device notified bodies, excluding LRQA, that used to operate in the U.K. but have withdrawn their authorizations or allowed them to expire. The withdrawals and expirations date back to 2000 and only one notified body, AMTAC Certification Services, has exited the sector since 2011. AMTAC stopped being a notified body for medical devices in 2018, four years after pulling out of the IVD sector.