EMERGO BY UL SUMMARY OF KEY POINTS:

  • The NANDO database has been updated to include the new Notified Body BSI Netherlands.
  • BSI Group The Netherlands is formally designated to carry out conformity assessments according to the MDD, AIMDD and IVDD.
  • BSI Group now has two entities, BSI UK with Notified Body number 0086 and BSI-NL with Notified Body number 2797.

Information updated on December 13, 2018.

Although the first Notified Bodies (NBs) will soon be designated to the European Medical Devices Regulation (EU) 2017/745 (MDR), the New Approach Notified and Designation Organisations (NANDO) database has been updated with a new NB for the current Medical Devices Directive 93/42/EEC, Active Implantable Medical Device Directive 90/385/EEC and In Vitro Diagnostic Medical Devices Directive 98/79/EC. BSI has now two NBs, each with its own NB number. The designation of an NB in The Netherlands is a relief for manufacturers currently certified by UK- based NBs, as CE Mark certificates may become void as a result of a Cliff-edge Brexit.

New Notified Body listed on NANDO

NBs need to receive formal appointment by a European Union Member State before they may be designated to carry out conformity assessments according to EU directives or legislation. The directives and regulations list the requirement that need to be fulfilled by the NB.

NANDO lists all EU Directives and Regulations, as well as the NBs that are designated to issue CE Mark certificates for these Directives and Regulations accordingly. Notification of NBs as well as their withdrawal (“denotification”) are the responsibility of the notifying Member State.

In late summer 2018, BSI The Netherlands (BSI-NL) announced that they had successfully completed the Joint Assessment for designation to the MDD, AIMDD and IVDD. However, they had to wait until formal listing in NANDO before they would be able to issue certificates according to the Directives. This listing in NANDO also provides the NB number, 2797.

Transferring from a UK-based Notified Body

Now that BSI-NL is listed on NANDO, they are formally allowed to issue certificates to the MDD, AIMDD and IVDD. BSI-NL has indicated to be in the process of getting designated to the new Regulations as well.

So, what would be the benefits of transferring at this moment from a UK-based NB to a non-UK based NB?

Although the MDR applies as of May 26, 2019, the designation of a new NB in the EU-27 outside the UK is still good news. Brexit may affect the validity of certificates issued by UK-based NBs. In the event of a Cliff-edge or Hard Brexit, by March 29, 2019 UK-issued certificates may become void . This could also happen during the transition period until 31 December 2020, for which the UK Parliament still has to vote. Unless a lasting agreement is reached concerning a so-called “Soft Brexit,” UK-issued certificates will become void sooner or later anyway, and it is widely predicted this will be rather soon.  

Clients certified by BSI UK (0086) are expected to be able to undertake a smooth transition to BSI-NL (2797). BSI-NL named this procedure a migration procedure. Through this route these manufacturers will be able to keep valid certificates from an EU-based NB without interruption.

Emergo recommends that manufacturers currently certified with BSI UK or any other UK-based NB contact their NB without delay to ensure uninterrupted validity of their CE Mark certificates.

Related European Medical Device Regulatory Information from Emergo by UL:

Author

  • Annette van Raa...