EU Notified Bodies for Medical Devices: An Overview

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EU Notified Bodies for Medical Devices

Certain products covered by the Medical Devices Regulation (MDR) require the involvement of a notified body before being placed in the EU market. The extent of the involvement of the notified body is determined based on the classification of the medical device.

In this guide, we explain in which case a notified body should be approached. Additionally, we provide a list of various notified bodies in the EU for medical devices and explain how you can search for a notified body in other EU member states.

Methodology

The list of EU-notified bodies that we provide is retrieved from the notified bodies (NANDO) database. Note that we only provide examples of notified bodies for some countries, not a definitive list.


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What is a notified body?

In the context of the Medical Devices Regulation, a notified body is an independent organisation selected by an EU member state to assess whether the medical device fulfils the requirements of the Medical Devices Regulation. If a notified body is involved, it is the notified body that “grants” the CE marking for the product.

The tasks performed by the notified body include the following:

a. Examining the technical design and testing the product according to relevant technical specifications under the applicable regulation(s)

b. Reviewing compliance documentation

c. Auditing the manufacturer’s quality management system

d. Performing product checks at random intervals

e. Drawing up evaluation reports

f. Issuing the EU-type examination certificate

Which medical devices require a notified body?

The Medical Devices Regulation requires medical devices to go through a conformity assessment procedure to ensure the product’s compliance with the relevant requirements. However, the procedure differs according to the classification of the medical device and will indicate whether a notified body is needed.

For example, a notified body is required for the following classes of medical devices:

a. Class I medical devices that are sterile, possess a measuring function or reusable surgical instruments

b. Class IIa medical devices

c. Class IIb medical devices

d. Class III medical devices

What kind of documents are required?

The activities of a notified body are explained in Annexes IX, X, and XI of the Medical Devices Regulation. The conformity assessment procedure for each class of medical device will specify which Annexes to refer to. In these Annexes, documentation requirements are mentioned.

While a Declaration of Conformity, a technical file, and test reports are always required, there are some documents that are specific for the different conformity assessments that require a notified body. We provide a summary in the table below

Requi
rements
Annex IX Annex X Annex XI
Scope Class I (ls/m/r)*

Class IIa

Class IIb

Class III

Class IIb

Class III

Class I (Ls/m/r)*

Class IIa

Class IIb

Class III

Documen
tation
1. Documentation on quality management system

2. Documentation on post-market surveillance plan

3. Quality control reports and test data

1. Clinical evaluation report

2. EU type-examination certificates

1. Certificate under Part A or B of Annex XI (Production quality assurance or product verification respectively)

Note*: Class I (ls/m/r) refers to Class I medical devices that are:

a. Placed in the EU market in sterile condition (ls)

b. Have a measuring function (m)

c. Reusable surgical instruments (r)

How do I find a Notified Body?

Notified bodies based in the EU can be found through the NANDOS database. To search for notified bodies for medical devices, follow the instructions below:

1. Go to the above-mentioned link

2. Click the link entitled “Notified bodies”

3. Click the link entitled “Search by legislation”

4. Under the column “Legislation name” find the link entitled “Regulation (EU) 2017/745 on medical devices”

Germany

TÜV NORD CERT GmbH

TÜV NORD is a notified body in Germany which provides services for multiple product categories, including medical devices.

Their services centre around Medical Devices Regulation certification and include the following:

  • Quality management system audit
  • Review of technical documentation and clinical documentation
  • Issuance of the certification
  • Ongoing post-market surveillance

Location: Am TÜV 1, 30519 Hannover

TÜV SÜD Product Service GmbH

TÜV SÜD claims to be one of the first few testing houses to be designated as a notified body for the Medical Devices Regulation.

Their website mentions the following services:

  • Quality Management and Quality Control for Medical Devices
  • Clinical services
  • Technical Documentation Assessment
  • Medical Devices Testing
  • Issuance of the certification

Location: Ridlerstraße 65, 80339 München

Ireland

National Standards Authority of Ireland (NSAI)

The NSAI is the only notified body available for medical devices under the Medical Devices Regulation in Ireland.

Their services include:

  • Quality system audits
  • Initial certification audit and other subsequent surveillance audits
  • Technical documentation reviews
  • Issuance of the certification

Location: 1 Swift Square, Northwood, Santry, Dublin 9

Italy

IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

IMQ was one of the first companies to be selected to take on the role of a notified body.

They offer the following services:

  • Medical Device Single Audit Program auditing services
  • Product certification service
  • Management system certification (ISO) (ISO 13485 for medical devices)

Location: Via Quintiliano, 43, 20138 – Milano

Eurofins Product Testing Italy S.r.l.

Recently Eurofins Product Testing Italy was designated as a notified body for medical devices in Italy.

They offer the following services:

  • Certification
  • Biological Risk Assessment
  • Toxicological Risk Assessment
  • Support in filing and reviewing the Clinical Evaluation Report
  • Technical File compiling
  • Medical device testing

Location: Via Courgnè, 21, 10156 – Torino (To)

Spain

CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

This is the only active notified body for medical devices that is mentioned on the NANDO database that is active in Spain. Their services mentioned on their site include:

  • Certification (including modification of the certification)
  • Monitoring activities
  • Evaluation of the quality management system

Location: Campezo 1. Edificio 7., 28022 Madrid

Netherlands

DEKRA Certification B.V.

Dekra has two notified bodies in both Germany and the Netherlands for medical devices. Their services include:

  • Medical device single audits
  • Quality management system auditing services
  • Certification

Location: Meander 1051 / P.O. Box 5185, 6825 MJ Arnhem / 6802 Ed Arnhem

Kiwa Dare B.V.

Kiwa Dare B.V. is designated to perform conformity assessments for active (electronic) non-implantable medical devices under the Medical Devices Regulation.

Their services mentioned on their site include:

  • Certification under Annex X and Annex XIB
  • Certifying the quality management system under Annex IX or Annex XIA
  • Certifying the technical documentation under Annex IX or Annex XIA

Location: Vijzelmolenlaan 7, NL-3447 GX Woerden

France

GMED SAS

This company is a notified body in France for medical devices. Their services mentioned on their site include the following:

  • Certification
  • Quality management system certification

Location: 1, rue Gaston Boissier, 75015 Paris

Poland

POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

This company generally offers services surrounding the certification of management systems, testing and certification of products and training in Poland. Additionally, under the Medical Devices Regulation, they are notified bodies for medical devices.

Their services mentioned on their site include:

  • EU technical documentation assessment certificate under Annex IX Chapter II
  • EU quality management system certificate under Annex IX Chapter I
  • EU quality assurance Certificate under Annex XI part A
  • Surveillance auditing services
  • Assessing the Periodic Safety Update Report

Location: ul. Puławska 469, 02-844 Warszawa

TUV NORD Polska Sp. z o.o

TUV NORD is in the certification and inspection industry and is a notified body for medical devices in Poland. Their services mentioned on their site include the following:

  • Certification
  • Assessment of the management system documentation
  • Assessment of the product conformity documentation
  • Surveillance auditing services

Location: ul. Mickiewicza 29, 40-085 Katowice

Belgium

SGS Belgium NV

This company is the only active notified body in Belgium for medical devices mentioned on the NANDO database. Their services include:

  • Certification
  • Assessment of the quality management system
  • Assessment of the technical documentation
  • Product Conformity Assessment services under Annex XI
  • Medical devices single audit program

Location: Noorderlaan 87, BE-2030 Antwerpen

Sweden

Intertek Medical Notified Body AB

Intertek offers worldwide assurance, testing, inspection and certification solutions for different industries, including medical devices. Furthermore, Intertek Medical Notified Body AB is designated as a notified body to certify medical devices in Sweden. Their services mentioned on their site include:

  • Certification
  • Medical devices single audit program
  • Quality management systems certification

Location: Torshamnsgatan 43, Box 1103, SE-164 22 Kista

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    Disclaimer: The Site cannot and does not contain legal advice. The legal information is provided for general informational and educational purposes only and is not a substitute for professional advice. Accordingly, before taking any actions based upon such information, we encourage you to consult with the appropriate professionals. We do not provide any kind of legal advice. THE USE OR RELIANCE OF ANY INFORMATION CONTAINED ON THE SITE IS SOLELY AT YOUR OWN RISK.

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    Sources: Our articles are written in part based on publicly available information, and our own practical experience relating to product compliance. These are some of the primary sources we use:

    • ec.europa.eu
    • echa.europa.eu
    • ecfr.gov
    • cpsc.gov
    • ftc.gov
    • fcc.gov
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