Update on Notified Bodies designation under MDR / IVDR

02 July 2021 |

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The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task for the whole sector.

Whilst significant efforts have been undertaken in the designation of Notified Bodies, availability and capacity for review and support under the new frameworks remain a key challenge for Industry. Let’s have a look at the progress made over the past year.

Update on NB designation

In comparison to the original total number of MDD Notified Bodies (126), only twenty (20) currently have MDR designation.

In the IVD space, where the magnitude of Regulatory changes is even more significant, the number of designated bodies under IVDR is also still vastly insufficient, with only five (5) NBs designated, down from thirty-nine (39) under the old IVDD.

Here is a summary of designation as of 1 July 2021:

NB Number Name Country MDR IVDR
.# NB 2265 3EC International a.s. Slovakia
.# NB 2797 BSI Group The Netherlands B.V. Netherlands
.# NB 2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. Hungary
.# NB 1912 DARE!! Services B.V. Netherlands
.# NB 0344 DEKRA Certification B.V. Netherlands
.# NB 0124 DEKRA Certification GmbH Germany
.# NB 2460 DNV Product Assurance AS Norway
.# NB 0297 DQS Medizinprodukte GmbH Germany
.# NB 0537 Eurofins Expert Services Oy Finland
.# NB 0459 GMED France
.# NB 0051 IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Italy
.# NB 0373 ISTITUTO SUPERIORE DI SANITA’ Italy
.# NB 2862 Intertek Medical Notified Body AB Sweden
.# NB 0483 MDC MEDICAL DEVICE CERTIFICATION GMBH Germany
.# NB 0482 MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Germany
.# NB 0050 National Standards Authority of Ireland (NSAI) Ireland
.# NB 0598 (ex-0403) SGS FIMKO OY Finland
.# NB 0197 TÜV Rheinland LGA Products GmbH Germany
.# NB 0123 TÜV SÜD Product Service GmbH Zertifizierstellen Germany
.# NB 2696 UDEM Adriatic d.o.o. Croatia
Total count
20
5
Differential since May 2020
+7
+1

Table Source: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

Comparing these numbers with our 2020 NB update also illustrates the very slow progress made in the designation process in the last year. This is due to a range of factors that are directly related to the complexity in implementation (scale of requirements and lack of guidance under MDR/IVDR) as well as external factors such as Covid-19 and Brexit (with the removal of UK NBs from eligible Conformity Assessment bodies).

Limitations in the transitional arrangements

During the transition period, Notified Bodies designated to the old Directives (MDD and IVDD) can continue to issue certificates under these schemes until the Date of Application of the new Regulations.

Notified Bodies can then begin to issue certificates to the new regulations (IVDR and MDR) once they have been designated.

After the Date of Application of the Regulations, Notified Bodies are only able to issue certificates to new Regulations. So, in other words, certificates for new Medical Devices can now only be issued against MDR and certificates for IVDs can still be issued under IVDD for a limited time and may have limited validity (especially in situations of Classification changes).

More challenges ahead

Despite the progress achieved over the year in terms of designation of notified bodies under the new MDR and IVDR, concerns remain about the capacity of Notified Bodies, both in certifying products under the new Regulations and in renewing certificates issued under the old Directives.

There is a risk that the validity of existing certificates will gradually expire without being immediately replaced by certificates under the new MDR and IVDR, which could potentially lead to shortages of devices essential for healthcare. This shortage may impact of course devices supplied to Europe but also potentially supply of products in regions where EC certificates are used as equivalent evidence of conformity assessment (e.g., Australia), although most regulators that accept CE certificates have put contingency plans in place.

Clearly, challenges in the transitional implementation of the new Regulations are not over. Beyond the designation process, it is also worth highlighting that cooperation and collaboration in the post-market surveillance and vigilance phases will also affect capacity from all actors involved (both the Regulators and Industry). Let’s also not forget the uncertainty around the operational development of EUDAMED. Following the release of the actor module (see our EUDAMED is Live blog) functional developments are still required for most of the modules that are pivotal to the full implementation of the Regulations.

Navigating the ever-changing Regulations can be perplexing. Our team is here to support you in these challenging times. Reach out to initiate a conversation and see how we can support you.

We tailor our services to the requirements of your business and can help you implement plans that are best suited to your projects. Contact us now 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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