Most medical device manufacturers seeking to sell their products in the European Union (EU) must work with Notified Bodies in the process. A Notified Body is an organisation appointed by an EU country to check the conformity of products before being placed on the market. After successfully completing a conformity assessment procedure, conformity is then made visible by a CE mark on the medical device.
What is the role of a Notified Body?
The Notified Bodies’ primary task in this process is to provide the conformity assessment services according to the relevant directives, thereby taking into account all the relevant guidance documents and standards. This can include the inspection and examination of the product itself, its design and the manufacturing environment and processes associated with it. For this assessment, the Notified Body must operate in a non-discriminatory, transparent, independent and impartial manner.
The European Commission keeps a list of notified bodies by EU countries on the NANDO (New Approach Notified and Designated Organisations) website. The following offers an overview of all current Notified Bodies listed in the online database which are already MDR certified. This list will be updated on an ongoing basis as more Notified Bodies are approved for the EU MDR.
BSI Assurance UK Ltd
BSI Assurance is certified for the MDR and IVDR. Other focus areas include construction products, pressure equipment and personal protective equipment. Update: From January 2021 onwards, Notified Bodies in the UK will no longer be able to carry out conformity assessments for the EU market.
BSI Group The Netherlands B.V.
The second BSI Notified Body in the EU is based in Amsterdam and is also MDR and IVDR certified.
CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.
Certiso is based in Budapest and certified for both the MDR and the IVDR.
DARE!! Services B.V.
This notified body is certified for the MDR and IVDR. It additionally specialises in electromagnetic compatibility.
DEKRA Certification GmbH
DEKRA Certification GmbH is the largest inspection company in Germany and MDR and IVDR certified.
DNV GL Presafe AS
Presafe is a Notified Body for Medical Devices and Hazardous Area Equipment.
DQS Medizinprodukte GmbH
This Notified Body is completely specialised on Medical Devices and is based in Frankfurt, Germany.
GMED is a Notified Body based in Paris and focuses on the certification of medical devices.
IMQ Instituto Italiano del Marchio di Qualita S.P.A.
IMQ focuses on a variety of topics including Management System Certification, Inspections and Audits and Product Certification such as medical devices.
Intertek Medical Notified Body AB
Intertek is a multinational inspection, product testing and certification company. The subsidiary in Sweden focuses solely on the certification of medical devices according to EU MDR. www.intertek.se
MDC Medical Device Certification GmbH
This notified body focuses specifically on the certification of products in the medical field and is certified for the MDR and IVD.
MEDCERT Zertifizierungs- und Prüfungsgesellschaft für die Medizin GmbH
MEDCERT is one of the largest Notified Bodies in Germany in the medical industry. http://www.medcert.de
National Standards Authority of Ireland (NSAI)
The NSAI is responsible for standards, certifications and legal metrology, amongst others. www.nsai.ie
TÜV Rheinland LGA Products GmbH
TÜV Rheinland is an internationally active, independent testing service provider based in Cologne and operates in the areas of safety, efficiency and quality.
TÜV SÜD Product Service GmbH Zertifizierstellen
TÜV SÜD is a technical testing organization that offers a wide range of services with testing and certification as its main focus.
3EC International a.s.
This notified body is accredited for seven management system standards. In terms of product certification, this body is focused on medical devices and is certified for the MDR and IVD.
After a medical device has been placed on the market, manufacturers must collect data in order to continuously confirm device quality, safety and performance. These Post-Market Surveillance (PMS) activities, however, can be easily automated in time for the EU MDR by using an EDC system. If you want to learn more about the EU MDR and how to start collecting and managing your clinical data electronically, sign up for a free trial!