Which notified bodies are designated for MDR?
Below is an updated list of all the Notified Bodies currently designated under EU MDR:
- UDEM Adriatic d.o.o. (Croatia)
- GMED (France)
- Eurofins Expert Services Oy (Finland)
- SGS Fimko Oy (Finland)
- DEKRA Certification GmbH (Germany)
- DQS Medizinprodukte GmbH (Germany)
- MDC Medical Device Certification GmbH (Germany)
What is a Notified Body for medical devices?
A notified body (NB) is an organization in charge of the conformity assessmentof medical devices before they are placed on the market or put into service. These actions include obtaining one or more CE marking certificates, which attest devices conformity to European regulatory standards.
What type of organization is a Notified Body?
More generally, a notified body is an independent, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and regulations, the accrediting body may allow a notified body to provide verification and certification services.
Is DQS a notified body?
DQS is the 16th MDR-designated notified body, and sixth from Germany, which has the largest share of any single country.
Is UL a notified body?
Under Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDD), UL has taken the decision to restrict its designation as a Notified Body. This means that effective from September 01, 2019, UL will only hold designation to IVD 0308 under the IVDD.
Is TUV A notified body?
TÜV SÜD Product Service is among the world’s first certification bodies to receive designation as a Notified Body for the new Medical Device Regulation (MDR) by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
Is a notified body a regulatory authority?
Notified Bodies are responsible for assessing medical devices (MDs) and diagnostics (IVDs). They are an indispensable part of the regulatory system since they grant a CE mark to each device before it can be placed in the EU market.
What is DQS Med?
DQS Medizinprodukte GmbH emerged from one of the oldest and most experienced service providers of certification and assessment of management systems and processes in Germany, the DQS GmbH and enjoys an excellent reputation with the public, institutions and financial backer.
What is UL and CE?
The letters CE means that the product meets the European Union’s safety standards and other requirements for sale. UL means the product meets the standards of Underwriters Laboratories, a private safety testing organization, and FCC means the product meets the standards of the Federal Communications Commission.
Is UL accepted in Europe?
UL’s Marks for Europe apply to both electrical and electronic products and components intended for use in Europe.
Which is the first notified body under iVDR?
TÜV SÜD is the first notified body designated under IVDR this year and joins fellow Germany-based firm Dekra Certification and the U.K and Dutch wings of BSI on the small list of bodies cleared to handle IVDR certifications.
Where can I find list of Notified Bodies?
The Commission strives to maintain an up-to-date list of bodies notified by EU countries and make the necessary information available to all interested parties. Lists of Notified Bodies can be found on the NANDO website (New Approach Notified and Designated Organisations).
How many notified bodies are designated to MDR?
Part of conformity planning, of course, it to contract with a Notified Body designated to these regulations to meet current and future regulatory obligations. As of 10 July 2020, there are 15 Notified Bodies designated to MDR and four (4) designated to IVDR, with at least nine (9) additional NBs pending designation.
How are notified bodies carried out in the EU?
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. How Can RegDesk Help?