Notified Body Updates for MDD, MDRs, IVDD and IVDR

04 May 2020 | Luis Jimenez | VP of Business Development

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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 NumberNotified Body (and link)CountryDate of latest MDR Certification
0086BSI Assurance UK LtdUnited Kingdom13/02/2020
2797BSI Group The Netherlands B.V.Netherlands07/02/2020
2409CE Certiso Orvos- és Kórháztechnikai EllenőrzőHungary21/03/2020
1912DARE!! Services B.V.Netherlands5/11/2019
0344DEKRA Certification B.V.Netherlands06/03/2020
0124DEKRA Certification GmbHGermany28/08/2019
2460DNV GL Presafe ASNorway06/02/2020
0051IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.Italy20/08/2019
0483MDC MEDICAL DEVICE CERTIFICATION GMBHGermany25/04/2020
0482MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBHGermany25/12/2019
0050National Standards Authority of Ireland (NSAI)Ireland13/02/2020
0197TÜV Rheinland LGA Products GmbHGermany26/09/2019
0123TÜV SÜD Product Service GmbH ZertifizierstellenGermany06/11/2019


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

Notified Body NumberNotified Body (and link)CountryDate of latest IVDR Certification
0086BSI Assurance UK LtdUnited Kingdom13/02/2020
2797BSI Group The Netherlands B.V.Netherlands07/02/2020
0124DEKRA Certification GmbHGermany10/10/2019
0086BSI Assurance UK LtdUnited Kingdom13/02/2020


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 NumberNotified Body (and link) MDRIVDR
0633Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbHYesUnknown
0297DQS Medizinprodukte GmbHYesUnknown
1282ENTE CERTIFICAZIONE MACCHINE SRLYesUnknown
0413INTERTEK SEMKO ABYesUnknown
1434POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.YesYes
TBDQMD ServicesYesYes
1639SGS Belgium NVYesYes
0120SGS United Kingdom LimitedYesYes
0044TÜV NORD CERT GmbHYesUnknown


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 NumberNotified Body (and link)Country
22653EC International a.s.Slovakia
0318AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOSSpain
0086BSI Assurance UK LtdUnited Kingdom
2797BSI Group The Netherlands B.V.Netherlands
1370BUREAU VERITAS ITALIA S.P.A.Italy
0633Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbHGermany
2409CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.Hungary
0546CERTIQUALITY S.R.L. – ISTITUTO DI CERTIFICAZIONE DELLA QUALITA’Italy
1912DARE!! Services B.V.Netherlands
0344DEKRA Certification B.V.Netherlands
0124DEKRA Certification GmbHGermany
2460DNV GL Presafe ASNorway
0297DQS Medizinprodukte GmbHGermany
2282DQS Polska Sp. z o.oPoland
1014ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.Czech Republic
1282ENTE CERTIFICAZIONE MACCHINE SRLItaly
0537Eurofins Expert Services OyFinland
0681Eurofins Product Service GmbHGermany
0477Eurofins Product Testing Italy S.r.l.Italy
2803G.F.I. Health Technology Certification LtdCyprus
0459GMEDFrance
0425ICIM S.P.A.Italy
0051IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.Italy
1023INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.Czech Republic
0413INTERTEK SEMKO ABSweden
0373ISTITUTO SUPERIORE DI SANITA’Italy
0426ITALCERT SRLItaly
0476KIWA CERMET ITALIA S.P.A.Italy
1984Kiwa Belgelendirme Hizmetleri A.Ş.Turkey
0483MDC MEDICAL DEVICE CERTIFICATION GMBHGermany
0482MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBHGermany
0068MTIC InterCert S.r.l.Italy
0653NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTYGreece
0050National Standards Authority of Ireland (NSAI)Ireland
2764Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim ŞirketiTurkey
1011Országos Gógyszerészeti és Élelmezés-egészségügyi Intézet Eszközminősítő és Kórháztechnikai Igazgatóság (National Institute of Pharmacy and Nutrition)Hungary
1434POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.Poland
0543Presafe Denmark A/SDenmark
0402RISE Research Institutes of Sweden ABSweden
1639SGS Belgium NVBelgium
0598 (ex-0403)SGS FIMKO OYFinland
0120SGS United Kingdom LimitedUnited Kingdom
0494SLG PRÜF UND ZERTIFIZIERUNGS GMBHGermany
1304SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SIQSlovenia
1250Schweizerische Vereinigung für Qualitäts- und ManagementsystemeSwitzerland (MRA)
2195Szutest Uygunluk Değerlendirme A.Ş.Turkey
0805THERAPEUTIC GOODS ADMINISTRATIONAustralia (MRA)
1783TURKISH STANDARDS INSTITUTION (TSE)Turkey
2274TUV NORD Polska Sp. z o.oPoland
1936TUV Rheinland Italia SRLItaly
0044TÜV NORD CERT GmbHGermany
0197TÜV Rheinland LGA Products GmbHGermany
0123TÜV SÜD Product Service GmbH ZertifizierstellenGermany
2292UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.Turkey
2854bqs. s.r.o.Slovakia
0481ecm-Zertifizierungsgesellschaft für Medizinprodukte in Europa mbHGermany


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 NumberNotified Body (and link)Country
22653EC International a.s.Slovakia
0318AGENCIA ESPAÑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOSSpain
0086BSI Assurance UK LtdUnited Kingdom
2797BSI Group The Netherlands B.V.Netherlands
2409CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.Hungary
0344DEKRA Certification B.V.Netherlands
1293EVPU a.s.Slovakia
0537Eurofins Expert Services OyFinland
0459GMEDFrance
1023INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s.Czech Republic
0373ISTITUTO SUPERIORE DI SANITA’Italy
0483MDC MEDICAL DEVICE CERTIFICATION GMBHGermany
0050National Standards Authority of Ireland (NSAI)Ireland
1011Országos Gógyszerészeti és Élelmezés-egészségügyi Intézet Eszközminősítő és Kórháztechnikai Igazgatóság (National Institute of Pharmacy and Nutrition)Hungary
1434POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.Poland
0543Presafe Denmark A/SDenmark
0120SGS United Kingdom LimitedUnited Kingdom
1783TURKISH STANDARDS INSTITUTION (TSE)Turkey
0197TÜV Rheinland LGA Products GmbHGermany
0123TÜV SÜD Product Service GmbH ZertifizierstellenGermany
0843UL INTERNATIONAL (UK) LTDUnited Kingdom
2854bqs. 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

We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)

Disclaimer
The views and options expressed in this article are those of the author/s and do not necessarily reflect the views of Brandwood CKC Pty Ltd ACN 128 762 505.

The information presented in this article is of a general nature only and does not consider the particular circumstances of your business. Prior results and case studies do not guarantee a similar outcome in future. You should not rely on this information, and you should seek specific advice for your particular business needs.

Where indicated, certain content has been sourced from third parties; we have not independently verified it. Neither Brandwood CKC nor the author makes any warranty as to the accuracy, completeness or reliability of this article, nor do those parties accept any liability or responsibility arising in any way from omissions or errors contained in the content.

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