BSI Becomes First Notified Body Designated under Europe's MDR
Regulatory Updates | In-Vitro Diagnostic Devices, Medical Devices
EMERGO BY UL SUMMARY OF KEY POINTS:
- The designation of BSI UK is in NANDO;
- This does not cover BSI NL;
- Other Notified Bodies are expected to follow soon.
The new Medical Devices Regulation (EU) 2017/745 is not an update of the current Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD); it requires all devices to be certified again.
Except for Class I, self-certified devices, all devices require new certification by a Notified Body (NB). NBs can only certify for the MDR if they are designated for it. The designation process formally started on November 26th, 2017, which was six months after the date of entry into power of the MDR. On that date potential NBs could express their interest in being designated for one or more of the scope codes for medical devices and IVDs. Those scope codes had been released on the previous day by the European Commission after they had been adopted by the newly installed Medical Device Coordination Group (MDCG). After an NB had expressed its interest, the process of designation could start, which consists of Joint Assessment Team audits, corrective actions and the formal designation by the National Competent Authority for designating NBs. This is complex and time-consuming process, which has, almost 14 months after its start, resulted in the first NB designated for the MDR.
The British Notified Body BSI-UK is the first to cross that line, as can be seen in the European Database for Notified Bodies, NANDO. According to NANDO no NB has yet been designated for IVDs, but this may follow shortly. The designation covers all NBOG codes, and for all these codes BSI is designated for Annex IX(I) (Quality Management System), Annex IX(II) (Assessment of Technical Documentation) and Annex XI(A) (Production Quality Assurance).
BSI is only designated for Annex X (Type Examination) and Annex XI(B) (Product Verification) for codes MDA 0305 (Active non-implantable devices for stimulation or inhibition), MDN 1210 (Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases), MDN 1214 (General non-active non-implantable devices used in health care and other non-active non-implantable devices – limited to gloves). In more general terms, BSI can audit quality system, review technical documentation but their testing capacities are limited.
BSI and Brexit
As there is the possibility of the UK leaving the EU without a deal on March 29th, 2019, this designation may only be relevant for manufacturers that only place their devices on the UK market. In case of a no-deal Brexit all UK based NBs will become de-designated after March 29th and their certificates will be void immediately. BSI has opened an office in The Netherlands, which operates under its own NB number. Therefore BSI-NL is not the same NB as BSI-UK, and certificates cannot be exchanged automatically between them. However, the Dutch Competent Authority has agreed that transfer of certificates between these two organizations can be done quite smoothly, with as little administrative burden as possible.
Emergo by UL expects that other NBs will soon be designated for the MDR as well. Once a NB is designated, it can start quoting, auditing, reviewing and certifying for the MDR. Hopefully there will be sufficient capacity soon for all devices that require certification. BSI now being designated signals a new phase in the implementation of the MDR.