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Home > News & Events > Blog > Notified Body Updates for MDD, MDRs, IVDD and IVDR

Notified Body Updates for MDD, MDRs, IVDD and IVDR

Magnifier drug

Author: Luis Jimenez

This article is current as at 29 April 2020

The European Parliament has voted to postpone the implementation deadline for MDR from May 2020 to May 2021. This gives a 12-month extension for those device manufacturers who have gotten caught in the middle. For our analysis on the extension click here.

Now that companies have a choice of MDD or MDR, and many companies are looking for emergency use reviews for their products, we cover who you can you go to for European registrations and provide corresponding contact information.

MDR ((EU) 2017/745) Certified Notified Bodies:

There is a total of 13 Notified Bodies certified for MDR. Interestingly, many of the already certified notified bodies have had revisions to their certifications. See below table including the latest MDR certification date:

Notified Body Number Notified Body (and link) Country Date of latest MDR Certification
0086 BSI Assurance UK Ltd United Kingdom 13/02/2020
2797 BSI Group The Netherlands B.V. Netherlands 07/02/2020
2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző Hungary 21/03/2020
1912 DARE!! Services B.V. Netherlands 5/11/2019
0344 DEKRA Certification B.V. Netherlands 06/03/2020
0124 DEKRA Certification GmbH Germany 28/08/2019
2460 DNV GL Presafe AS Norway 06/02/2020
0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Italy 20/08/2019
0483 MDC MEDICAL DEVICE CERTIFICATION GMBH Germany 25/04/2020
0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Germany 25/12/2019
0050 National Standards Authority of Ireland (NSAI) Ireland 13/02/2020
0197 TÜV Rheinland LGA Products GmbH Germany 26/09/2019
0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany 06/11/2019

IVDR ((EU) 2017/746) Notified Bodies:
Below is a table identifying the three notified bodies that are currently IVDR certified.

Notified Body Number Notified Body (and link) Country Date of latest IVDR Certification
0086 BSI Assurance UK Ltd United Kingdom 13/02/2020
2797 BSI Group The Netherlands B.V. Netherlands 07/02/2020
0124 DEKRA Certification GmbH Germany 10/10/2019
0086 BSI Assurance UK Ltd United Kingdom 13/02/2020

Pending Notified Bodies:
Although not extensive, this is a list of the notified bodies that have issued statements of their intention to apply for MDR and/or IVDR certification.

Notified Body Number Notified Body (and link) MDR IVDR
0633 Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH Yes Unknown
0297 DQS Medizinprodukte GmbH Yes Unknown
1282 ENTE CERTIFICAZIONE MACCHINE SRL Yes Unknown
0413 INTERTEK SEMKO AB Yes Unknown
1434 POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. Yes Yes
TBD QMD Services Yes Yes
1639 SGS Belgium NV Yes Yes
0120 SGS United Kingdom Limited Yes Yes
0044 TÜV NORD CERT GmbH Yes Unknown

MDD (93/42/EEC MDD) Certified Notified Bodies:

Now that the MDR deadline has been moved 12-months and companies may be looking for an MDD certificate, below is the current distribution of MDD certified Notified Bodies:

Note: this is an extensive sum, and the vast majority withdrew for unrelated reasons to the MDR.
Notified Body Number Notified Body (and link) Country
2265 3EC International a.s. Slovakia
0318 AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS Spain
0086 BSI Assurance UK Ltd United Kingdom
2797 BSI Group The Netherlands B.V. Netherlands
1370 BUREAU VERITAS ITALIA S.P.A. Italy
0633 Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH Germany
2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary
0546 CERTIQUALITY S.R.L. – ISTITUTO DI CERTIFICAZIONE DELLA QUALITA’ Italy
1912 DARE!! Services B.V. Netherlands
0344 DEKRA Certification B.V. Netherlands
0124 DEKRA Certification GmbH Germany
2460 DNV GL Presafe AS Norway
0297 DQS Medizinprodukte GmbH Germany
2282 DQS Polska Sp. z o.o Poland
1014 ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p. Czech Republic
1282 ENTE CERTIFICAZIONE MACCHINE SRL Italy
0537 Eurofins Expert Services Oy Finland
0681 Eurofins Product Service GmbH Germany
0477 Eurofins Product Testing Italy S.r.l. Italy
2803 G.F.I. Health Technology Certification Ltd Cyprus
0459 GMED France
0425 ICIM S.P.A. Italy
0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Italy
1023 INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. Czech Republic
0413 INTERTEK SEMKO AB Sweden
0373 ISTITUTO SUPERIORE DI SANITA’ Italy
0426 ITALCERT SRL Italy
0476 KIWA CERMET ITALIA S.P.A. Italy
1984 Kiwa Belgelendirme Hizmetleri A.Ş. Turkey
0483 MDC MEDICAL DEVICE CERTIFICATION GMBH Germany
0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Germany
0068 MTIC InterCert S.r.l. Italy
0653 NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY Greece
0050 National Standards Authority of Ireland (NSAI) Ireland
2764 Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi Turkey
1011 Országos Gógyszerészeti és Élelmezés-egészségügyi Intézet Eszközminősítő és Kórháztechnikai Igazgatóság (National Institute of Pharmacy and Nutrition) Hungary
1434 POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. Poland
0543 Presafe Denmark A/S Denmark
0402 RISE Research Institutes of Sweden AB Sweden
1639 SGS Belgium NV Belgium
0598 (ex-0403) SGS FIMKO OY Finland
0120 SGS United Kingdom Limited United Kingdom
0494 SLG PRÜF UND ZERTIFIZIERUNGS GMBH Germany
1304 SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SIQ Slovenia
1250 Schweizerische Vereinigung für Qualitäts- und Managementsysteme Switzerland (MRA)
2195 Szutest Uygunluk Değerlendirme A.Ş. Turkey
0805 THERAPEUTIC GOODS ADMINISTRATION Australia (MRA)
1783 TURKISH STANDARDS INSTITUTION (TSE) Turkey
2274 TUV NORD Polska Sp. z o.o Poland
1936 TUV Rheinland Italia SRL Italy
0044 TÜV NORD CERT GmbH Germany
0197 TÜV Rheinland LGA Products GmbH Germany
0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany
2292 UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. Turkey
2854 bqs. s.r.o. Slovakia
0481 ecm-Zertifizierungsgesellschaft für Medizinprodukte in Europa mbH Germany

IVDD (98/79/EC IVD) Certified Notified Bodies:

The IVDR implementation deadline is not due until 2022, so IVDD certifications are still very much in demand. Below is the distribution of total IVDD notified bodies:

Note: this is an extensive list and it includes notified bodies that have withdrawn for unrelated reasons to the IVDR introduction.
Notified Body Number Notified Body (and link) Country
2265 3EC International a.s. Slovakia
0318 AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS Spain
0086 BSI Assurance UK Ltd United Kingdom
2797 BSI Group The Netherlands B.V. Netherlands
2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary
0344 DEKRA Certification B.V. Netherlands
1293 EVPU a.s. Slovakia
0537 Eurofins Expert Services Oy Finland
0459 GMED France
1023 INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. Czech Republic
0373 ISTITUTO SUPERIORE DI SANITA’ Italy
0483 MDC MEDICAL DEVICE CERTIFICATION GMBH Germany
0050 National Standards Authority of Ireland (NSAI) Ireland
1011 Országos Gógyszerészeti és Élelmezés-egészségügyi Intézet Eszközminősítő és Kórháztechnikai Igazgatóság (National Institute of Pharmacy and Nutrition) Hungary
1434 POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. Poland
0543 Presafe Denmark A/S Denmark
0120 SGS United Kingdom Limited United Kingdom
1783 TURKISH STANDARDS INSTITUTION (TSE) Turkey
0197 TÜV Rheinland LGA Products GmbH Germany
0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany
0843 UL INTERNATIONAL (UK) LTD United Kingdom
2854 bqs. s.r.o. Slovakia

Conclusions

In comparison to the original total number of MDD certified Notified Bodies of 126, only 13 have current MDR certification. This reflects how rushed the MDR transition was even before the COVID-19 Pandemic, given that the original deadline was scheduled for May 2020. Further for the IVDR, the number of Notified Bodies for IVDs is reflecting a similar lag from 39 original IVDD notified bodies to 3 IVDR certified bodies. To date, for both IVD and Medical Device Notified Bodies, about 10% of them have made the cut to certification under the new regulations.

The MDR extension is sure going to help. In terms of IVDs, Med Tech Europe has already started to request that the IVDR be delayed (Click here).

Overall, these transitions are never easy, but they are manageable. When the TGA transitioned to its version of IVDR some 5 years ago, there was certainly a lot of pain, and then the dust settled, and we got on our way. We expect the same to happen in Europe, albeit on a bigger scale and with much larger global implications.

Let’s not forget that CE Mark has been historically the passport for approvals in a majority of international markets.

Need Help?

Navigating the ever-changing world of Notified Bodies can be perplexing. If you are having issues, let us help. Reach out to initiate a conversation.

References:

European Commission Website: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main

Useful Link to Queries:
MDR Certified Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

IVDR Certified Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

MDD Certified Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

IVD D Certified Notified Bodies: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20

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