Build your relationship with your Notified Body(ies)!

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 GmbH

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 Española 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.

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.

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