Feels like Ground Hog Day......another New Year, page-65

This could be the reason for delay: Due to the impending Brexit, BSI-UK would no longer be able to issue CE Marks under the EU's jurisdiction. It has put applications on hold to set up BSI-NL in The Netherlands so CE Marks applications could be transferred to this new Notified Body. If this is the hold up, I would be backing up my truck!

See  https://www.emergobyul.com/blog/2018/12/brexit-update-new-notified-body-designated-netherlands

Brexit Update: New NotifiedBody Designated in The Netherlands

Dec 6, 2018 byAnnette van Raamsdonk

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 updatedon December 13, 2018.

Although the firstNotified Bodies (NBs) will soon be designated to the European Medical DevicesRegulation (EU) 2017/745 (MDR), the New Approach Notified and DesignationOrganisations (NANDO) database has been updated with a new NB for the currentMedical Devices Directive 93/42/EEC, Active Implantable Medical DeviceDirective 90/385/EEC and In Vitro Diagnostic Medical Devices Directive98/79/EC. BSI has now two NBs, each with its own NB number. The designation ofan NB in The Netherlands is a relief for manufacturers currently certified byUK- based NBs, as CE Mark certificates may become void as a result of a Cliff-edge Brexit.

NewNotified Body listed on NANDO

NBs need to receiveformal appointment by a European Union Member State before they may bedesignated to carry out conformity assessments according to EU directives orlegislation. The directives and regulations list the requirement that need tobe fulfilled by the NB.

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

In late summer2018, BSI The Netherlands (BSI-NL) announced that they had successfullycompleted the Joint Assessment for designation to the MDD, AIMDD and IVDD.However, they had to wait until formal listing in NANDO before they would beable to issue certificates according to the Directives. This listing in NANDO also provides the NB number, 2797.

Transferringfrom a UK-based Notified Body

Now that BSI-NL islisted 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 designatedto the new Regulations as well.

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

Although the MDRapplies as of May 26, 2019, the designation of a new NB in the EU-27 outsidethe UK is still good news. Brexit may affect the validity of certificatesissued by UK-based NBs. In the event of a Cliff-edge or Hard Brexit, by March29, 2019 UK-issued certificates may become void . This could also happen duringthe transition period until 31 December 2020, for which the UK Parliament stillhas to vote. Unless a lasting agreement is reached concerning a so-called “SoftBrexit,” UK-issued certificates will become void sooner or later anyway, and itis widely predicted this will be rather soon.  

Clients certifiedby BSI UK (0086) are expected to be able to undertake a smooth transition toBSI-NL (2797). BSI-NL named this procedure a migration procedure. Through thisroute these manufacturers will be able to keep valid certificates from anEU-based NB without interruption.

Emergo recommendsthat manufacturers currently certified with BSI UK or any other UK-based NBcontact their NB without delay to ensure uninterrupted validity of their CEMark certificates.