A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market.
The conformity assessment is a process by which you demonstrate that the product complies with the requirements set out in the applicable legislation. A Notified Body is designated by a European Union and carries out third-party conformity assessment procedures including calibration, testing, certification, and inspection.
In particular, Notified Bodies relating to medical devices verify that the requirements of the specific legislation for a device is fulfilled.
In the 90’s the Directive 90/385/ECC and the Directive 93/42/ECC were put in place to standardize the requirements relating to the placing active implantable medical devices and medical devices, respectively, on the European market. Twenty years later, a new regulation was drawn up, Regulation (EU) 2017/745, that would replace these two directives. The new Regulation aims to ensure that safe product is put on the European market and, at the same time, consolidate research in the European Union and promote the EU as a world leader in the medical device sector. Besides, several important issues with the Directives were addressed, such as:
- Eliminating differences in interpretation of the directives
- Completing the gap between the old directives and new technologies
- Addressing the criticism related to PIP silicone breast implant scandal
The legal difference between “Directive” and “Regulation” is that a “Directive” is a legislative act setting objectives that all EU countries must reach and translate into their national legislation within a defined time frame. However, it is up to the individual states to determine how to achieve these goals by implementing them in their local laws. As a consequence, a Directive may be enforced in different manners in the EU Member States. A “Regulation” is defined as a binding legislative act. It is immediately applicable in its entirety in all Member States, and it overrules national laws.
The new Regulation came into force in 2017, with a 3-year implementation period, until the 26th of May 2020, when the Regulation would replace the Directives. However, due to the COVID-19 pandemic, the application of this law has been postponed until the 26th of May 2021.
There are specific Notified Bodies (NBs) dedicated to performing the conformity assessment of medical devices, precisely 56 NB under Directive 93/42/ECC. However, there are many fewer NBs designated to perform conformity assessment under the Regulation (EU) 2017/745. Here we show you the 19 Notified Bodies that currently have received their designation under this Regulation.
BSI Assurance UK Ltd:
Notified Body of the BSI group based in the United Kingdom. It is under 15 different legislations. BSI was the world’s first National Standards Body and was formed in 1901.
BSI Group The Netherlands B.V.:
This is another Notified Body of the BSI group. In this case, located in the Netherlands. It is designated under 9 legislations.
CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.:
Accredited certification body established in 2011 in Hungary. It is specialized in medical devices and is under 4 different legislations.
DARE!! Services B.V.:
This is an entity of a Norwegian company with more than 25 years of experience. As a Notified Body is under 3 legislations.
DEKRA Certification B.V.:
Notified Body belonging to the DEKRA group, one of the largest and oldest, founded in 1925. This Notified Body is based in the Netherlands and is designated under 8 legislations.
DEKRA Certification GmbH:
Another Notified Body of the DEKRA group, located in Germany and under 3 legislations. It is specialized only in medical devices and in vitro diagnostic medical devices.
DNV GL Presafe AS:
Notified Body founded in 2011 with headquarters in Norway dedicated to Medical Devices and Hazardous Area Equipment. It is characterized by being designated under 4 legislations.
The DQS Medical Devices Competence Center was approved as a notified body by the ZLG / ZLS as early as 1995 and has therefore been active in the field of medical device approval and management system certification in the healthcare sector. It is designated under 1 legislation concerning medical devices.
GMED is a Notified Body based in Paris and focuses on the certification of medical devices. It is designated under 1 legislation.
IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.:
IMQ is an Italian company focused on the conformity assessment sector with and experience of almost 70 years. This Notified Body is widely specialized, being designated under 13 legislations.
Intertek Medical Notified Body AB
Intertek is a leading provider of Total Quality Assurance for industries worldwide with over 130 years of experience. It has been the 14th Notified Body under the Regulation (EU) 2017/745 in fact, it is the only legislation under which it is designated.
MDC MEDICAL DEVICE CERTIFICATION GMBH:
MDC is founded in 1994, is one of the first Notified Bodies in Germany recognized by the European Medical Devices Directive 93/42 / EEC. It is specialized in medical devices and it is under 3 legislations.
MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH:
German Notified Body established in 1994. It is one of the largest Notified Bodies in Germany in the field of the medical technology industry. It is designated under 3 legislations concerning medical devices.
National Standards Authority of Ireland (NSAI):
Notified Body based in Ireland and with more than 20 years of experience. It is characterized by the fact that it is designated under 7 legislations.
SGS is a leading inspection, verification, testing, and certification company based in Helsinki. It is designated under 1 legislation on medical devices.
A global leader in independent inspection services founded 145 years ago in Germany. It is a highly specialized Notified Body because it is under 12 legislations.
TÜV SÜD Product Service GmbH Zertifizierstellen:
TÜV SÜD is a technical inspection association that was born in the late 1800s during the industrial revolution. It has more than 150 years of experience and as a Notified Body is designated under 13 legislations.
Udem Adriatic d.o.o:
UDEM Adriatic is a company specialized in System Certification which started its business in Zagreb, Croatia, in 2015 for Conformity Assessment activities. It is designated under 2 legislations.
Istituto Superiore di Sanità:
Istituto Superiore di Sanità (ISS) is an Italian public institution that leads a technical-scientific body of the Italian National Health Service and performs research, trials, control, counseling, documentation, and training for public health. It is designated under 3 legislations.
Eurofins Expert Services Oy:
Eurofins Expert Services is part of the Eurofins Group based in Espoo, Finland. It is designated under 1 legislation on Medical devices. NB Nº 0537
KIWA CERMET ITALIA S.P.A.:
Kiwa is a company specialized in Testing, Inspection and Certification (TIC). It is designated under 8 legislation on Medical devices. NB Nº 0476
Eurofins Product Testing Italy S.r.l.:
Eurofins Product Testing is part of the Eurofins Group based in Torino, Italy. It is designated under 8 legislation on Medical devices. NB Nº 0477
TUV Rheinland Italia SRL:
TUV Rheinland Italia SRL. It is designated under 3 legislation on Medical devices. NB Nº 1936