The European Notified Body (NB) is shrinking as additional organizations opt out of designation to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR). Ongoing lack of a Brexit resolution is also a factor in this NB exodus.
Announced last month, UK NB LRQA will cease CE Mark certification services under current Medical Device Directives and not seek MDR or IVDR designation. Now, Swiss NB QS Zurich announced it will not pursue MDR designation and will wind down NB operations at the end of October, 2019.
UL’s UK-based NB, UL International, is exiting as of September 1, 2019, and has partnered with Polish NB Polskie Centrum Badan I Certyfikacji (PCBC) in order for clients to transfer their CE Mark certifications and maintain European market access.
With only one EU-based NB, TÜV Süd, designated in the EU27 so far, many manufacturers remain uncertain about how to maintain their CE Marking. While BSI became the first NB designated under MDR, it is based in the UK. Companies should prepare now to switch their current NB relationships. According to Emergo, this should include:
- Ensuring technical documentation is up to date and fully compliant with MDR or IVDR requirements;
- Creating a company profile in which NBOG codes, conformity assessment procedures and global presence are summarized;
- Searching in the NANDO database for NBs that match your company profile.