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 Directive (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.
LQRA 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…