TEAM-NB published its Notified Bodies members’ intention to submit an application to be designated against MDR and/or IVDR.
The document indicates that 13 TEAM-NB members (see list below) have expressed their intention to apply to become Notified Bodies (NB) under the IVD Regulation 2017/746.
BSI Product Certification
DEKRA Certification GmbH
DEKRA Certification GmbH
Ente Certificazione Macchine Srl.
MDC Medical Device Certification
Presafe Denmark A/R
TÜV Rheinland LGA Product
UL International Limited
DEKRA Certification GmbH (0124) and Ente Certificazione Macchine Srl. (1282) are today not certified under the IVD Directive so these would be a new addition to the pool of NBs available to IVD manufacturers.
All the above NBs are also applying for designation to become NB under the MDR 2017/745, along with 11 others that are exclusively applying for designation to become NB under the MDR 2017/745.
Intertek AMTAC Certification
DARE!! Medical Certifications
DNV Nemko Presafe AS
TÜV Nord Cert.
Rumours are spreading that 2 conformity assessment bodies from the Canadian Medical Devices Conformity Assessment System (CMDCAS) and Medical Device Single Audit Program (MDSAP), whom today are not notified bodies under the MD/IVD Directives may apply for designation as a NB under the MDR/IVDR. It is unclear whether application will be submitted for both MDs and IVDs or only MDs.
Not all NBs are a member of TEAM-NB. According to NANDO, an additional 11 NBs are currently designated under the IVD Directive, which do not hold a membership to TEAM-NB:
Agencia Española de Medicamentos Y Productos Sanitarios
Istituto Superiore Di Sanità
TUV Austria Services GmbH
VTT Expert Services Oy
Országos Gógyszerészeti és Élelmezés-egészségügyi Intézet Eszközminősítő és Kórháztechnikai Igazgatóság
(National Institute of Pharmacy and Nutrition)
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
TURKISH STANDARDS INSTITUTION (TSE)
3EC International a.s.
CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
However, of these 11, other than VTT, Qarad has no evidence or information with regards to their intent to apply to become IVD-R NBs.
Considering the uncertainty whether all the applicant organizations will become notified bodies or not, there is a possible implication that the IVD industry will be confronted by a future in which only a little more than a dozen NBs will be enabled to act as NB under the IVDR 2017/746. The remaining NBs will thus be confronted by the enormous workload increase which is brought about by the re-classification of IVDs.
We would like to point out that the TEAM-NB document doesn’t say anything pertaining to the scope of application for which these NBs are seeking designation, it merely states their intent to apply.
Table II: Horizontal Codes = Total of 47 codes
Despite the many uncertainties and unknowns, you should focus your efforts in 2018 on building your strategic relationship with your notified body(ies) of choice. Ask them if they are willing to become a NB under the regulation(s) and if so if they have applied or will apply for codes that cover your product portfolio. You want to get these discussions going as soon as possible to start planning for alternatives or contingency plans if their feedback is negative to either of these questions.
Make sure you are on your NBs radar, so you can start to actively build your transition plan.
Qarad has a very experienced team of industry professionals that can help you in all aspects of your transition to compliance under the new Regulations. Don’t hesitate to contact us for more information.