2019年 7月 18日
The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt out of designation to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Devices Regulation (IVDR), with ongoing lack of resolution regarding Brexit continuing to have an impact as well.
Following news last month that UK NB LRQA will cease CE Mark certification services under current Medical Device Directives and not seek MDR or IVDR designation, Swiss NB QS Zurich announced it no longer plans to pursue MDR designation, and will wind down NB operations by October 31, 2019.
UL’s UK-based NB, UL International, will also close shop as of September 1, 2019, but has partnered with Polish NB Polskie Centrum Badan I Certyfikacji (PCBC) so that clients may transfer their CE Mark certifications and maintain European market access.
Two different but hardly exclusive factors drove QS Zurich and UL International to their decisions to end NB support in Europe.
In QS Zurich’s case, MDR designation requirements proved unfeasible. A spokesperson at QS Zurich informed Emergo by UL that they had initially intended to be designated for the MDR. However, the joint assessment audit in December 2018 resulted in serious findings; the company ultimately concluded that it is only possible to handle the deviations “with a disproportionately high effort.” Therefore they will no longer pursue MDR designation. This also means QS Zurich will have to stop their NB activities under the current Directives. They have informed their clients they will no longer support their CE Mark certificates from October 31st, 2019.
UL International faced a different challenge. Based in the UK, UL International needed to prepare for a no-deal Brexit. In the event that such a scenario comes to pass, British NBs would lose their designations under the current Directives and upcoming Regulations. To mitigate the risk to medical device and IVD manufacturing clients in the event that a no-deal Brexit results in loss of such designation, UL has formed a partnership with PCBC (NB 1434). Through this partnership, UL customers will be transferring their UL CE certificates across to PCBC, ensuring that UL’s NB customers will have continuous certification to enable them to continue to place products on the market and allow continued patient access to these devices. At this time about 80% of UL clients have moved to PCBC, while the remaining 20% have transferred to another EU27 Notified Body.
In addition, UL will retain regulatory experts on staff to provide conformity assessment services to partner EU NBs, as well as support existing and new clients with audits to the Medical Device Single Audit Program (MDSAP), ISO 13485, ISO 14971 and IEC 62304.
Furthermore, UL will for the time being keep their designation to the IVDD for NBOG code 0308 (risk of trisomy 21( incl. software)). Few NBs are currently designated for this code, so UL will keep this designation in place until either all clients with these certificates have transferred to another EU27 NB, or until a no-deal Brexit. A no-deal Brexit scenario would introduce the risk of specific tests no longer being available on the EU market.
It is far from certain how many additional NBs will cease CE Mark certification services for medical devices and IVDs in Europe. Turkish NBs, for example, will most likely not achieve designation to the MDR in the near term. Other NBs may also come to the conclusion that MDR designation requirements cannot be met in a practically acceptable way.
With only one EU 27-based NB, TÜV Süd, designated in the EU27 so far (BSI became the first NB designated under MDR, but is based in the UK), many manufacturers remain uncertain about how to maintain their CE Marking. Therefore it is recommended that companies prepare for potentially having to switch their NB relationships. As discussed in Emergo by UL’s whitepaper on changing NBs, such preparations should include:
Ronald Boumans is Senior Consultant, Regulatory Affairs at Emergo by UL in The Netherlands.