Build your relationship with your Notified Body(ies)!

2018/01/02

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.

 ID number
Notified Body
Country
0086 BSI Product Certification UK
0124 DEKRA Certification GmbH Germany
0344 DEKRA Certification B.V.
 Netherlands
1282 Ente Certificazione Macchine Srl.
Italy
0459 LNE/G-MED France
0088 LRQA UK
0483 MDC Medical Device Certification Germany
0050 NSAI Ireland
0543 Presafe Denmark A/R
Denmark
0120 SGS UK
0197 TÜV Rheinland LGA Product
Germany
0123 TÜV SÜD
Germany
0843 UL International Limited
UK

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.

ID number
Notified Body
Country
0473 Intertek AMTAC Certification
UK
1912 DARE!! Medical Certifications
Netherlands
0653 EKAPTY SA
Greece
2460 DNV Nemko Presafe AS
Norway
0297 DQS Medizinprodukte
Germany
0413 Intertek Semko
Sweden
1984 Kiwa Turkey
0482 MEDCERT Germany
1304 SIQ Ljubljana
Slovenia
2195 SZUTEST Turkey
0044 TÜV Nord Cert.
Germany

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:

 ID number
Notified Body
Country
 0318 Agencia Espanola de Medicamentos Y Productos Sanitarios Spain
0373 Istituto Superiore Di Sanità Italy
0408 TUV Austria Services GmbH
Austria
0537 VTT Expert Services Oy
Finland
1011 Országos Gógyszerészeti és Élelmezés-egészségügyi Intézet Eszközminősítő és Kórháztechnikai Igazgatóság
(National Institute of Pharmacy and Nutrition)
Hungary
1023 INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. Czech Republic
1293 EVPU a.s.
Slovakia
1434 POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. Poland
1783 TURKISH STANDARDS INSTITUTION (TSE) Turkey
2265 3EC International a.s.
Slovakia
2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary

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.

What does this mean to you?

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.

 

 

 

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