Jun 17, 2019

UK-based Notified Body Lloyd’s Register (LRQA) plans to withdraw European Notified Body (NB) services for medical device and IVD manufacturers later in 2019.

The company announced it will no longer support CE Mark certification services under the current Medical Devices Directive (MDD) or In-Vitro Diagnostic Medical Device Directive (IVDD), and will not seek designation under the upcoming Medical Devices Regulation (MDR) or In-Vitro Diagnostic Devices Regulation (IVDR). LRQA’s withdrawal of NB services is expected to be effective by September 10th, 2019. This will give their clients 90 days’ notice, more than the officially required 30 days. However, this deadline will occur in the middle of Europe’s holiday season, with many organizations operating with limited staff. Expert consultants may also be in short supply during this time due to holiday schedules.

Switching Notified Bodies

In theory, a manufacturer can switch NBs while they still have a valid CE certificate through a shortened certification route. In practice, the new NB taking on the manufacturer will audit the client and review documentation. These steps takes time, and in the current European regulatory environment in which  NBs are overloaded with work, this will result in longer lead times. It is even questionable whether companies that are forced to switch NBs now will be able to recertify under the current Directives.

LRQA reports that the organization is collaborating with MHRA, the UK Competent Authority, regarding its withdrawal plans. Most affected medical device and IVD manufacturers, however, will be looking or new NBs in other European Member States, requiring the involvement of other Competent Authorities, as well.

Brexit is already happening

As stated before: Brexit is already happening. Since March 2017, the UK has indicated its intention to leave the EU, and for many months a no-deal withdrawal scenario has been hanging over the European medical device and IVD markets. This means that many companies are preparing for a situation where cooperation across the new EU-UK border will be more complex. This has led EU-27-based organizations to focus on an EU-centric network, while and UK-based organizations focus on British networks. For LRQA this has been a time where clients left, while it is quite a challenge for a Notified Body to switch headquarters. So far BSI has been the only UK-based Notified Body that has successfully transitioned to the European mainland.

Learn more about European medical device and IVD regulatory issues at Emergo by UL:

  • Brexit transition consulting and in-country representation for medical device and IVD companies
  • On-site Medical Devices Regulation (MDR) training for manufacturers
  • European CE Marking strategy for medical devices
  • European CE Mark consulting for IVD manufacturers
  • Webinar: How to select or change your Notified Body