The end of Brexit transition period (31/12/2020) has brought many important changes also for the medical device community.
Today, we highlight the removal of UK-based Notified bodies from the NANDO database as of beginning of 2021. This results in fewer Notified bodies being able to certify medical devices for the EU market, and we list below the NBs that can assist a manufacturer in obtaining the CE Certificate in accordance with EU MDR (17 in total) & IVDR (4 in total).
MDR NB
| 2265 | 3EC International a.s. | Slovakia |
| 2797 | BSI Group The Netherlands B.V. | Netherlands |
| 2409 | CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. | Hungary |
| 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 |
| 0459 | GMED | France |
| 0051 | IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. | Italy |
| 2862 | Intertek Medical Notified Body AB | Sweden |
| 0483 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Germany |
| 0482 | MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH | Germany |
| 0050 | National Standards Authority of Ireland (NSAI) | Ireland |
| 0197 | TÜV Rheinland LGA Products GmbH | Germany |
| 0123 | TÜV SÜD Product Service GmbH Zertifizierstellen | Germany |
| 2696 | UDEM Adriatic d.o.o. | Croatia |
IVDR NB
| 2797 | BSI Group The Netherlands B.V. | Netherlands |
| 0124 | DEKRA Certification GmbH | Germany |
| 0197 | TÜV Rheinland LGA Products GmbH | Germany |
| 0123 | TÜV SÜD Product Service GmbH Zertifizierstellen | Germany |
Source: European Commission.(2020).NANDO.Retrieved on 04/01/2021 from https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main
For the specific scope of each Notified body, please click on the relevant link above.
Guidance on the new compliance process for the market of Great Britain & Northern Ireland can be found in our Library of Documents: UK & Switzerland. Do not forget that an appointment of UK Responsible Person and registration of devices to the MHRA is new mandatory requirement!
We advise to keep track of the UK website regularly to make sure you are aware of the specificity of the new regime.
MDlaw team would like to wish you a Happy, Healthy and Prosperous 2021!
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