What is ATEX Notified Body?
As an ATEX notified body, the Intertek lab in Edmonton is authorized to evaluate, document and certify that equipment and protective systems intended for the EU market meet the relevant applicable provisions of the ATEX Directive.
What is notified body number?
A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required.
What is the name of Turkey’s notified body?
Within the Kiwa Group, Kiwa Italy and Kiwa Turkey are Notified Bodies and can assess if medical devices with medium or high risk meet the legal requirements according to the MDD 93/42/EEC Directive.
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)
Does Turkey require CE?
c) Turkey is neither member of the EU, nor is considered a part of the EEA. However, Turkey has fully implemented many of the European CE marking directives. This means that for many products they also require CE marking.
Is a Notified Body a regulatory 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 BSI an EU notified body?
BSI was informed on 21 January 2019 by the Medicines and Healthcare products Regulatory Agency (MHRA) that its UK notified body is the first in Europe to be designated to the new MDR (EU 2017/745).
Is Dekra a notified body?
DEKRA Certification GmbH is a notified body and certification body for medical devices.
Who is the head of Notified Body 0086?
We are pleased to announce that Dr Suzanne (Suzie) Halliday has accepted the position as the UK Head of Notified Body 0086. Suzie has many years’ experience working in medical devices for BSI, as a Technical Specialist, QMS Assessor, Team Leader and Head of Medical Device Operations and Training.
How will Brexit affect UK Notified Body numbers?
Due to the ongoing Brexit trade negotiations and the unpredictable outcomes, there is an increased risk that products, including medical devices and IVDs labelled with a UK notified body number might face challenges in clearance at the EU border customs after 01 January 2021.
What is a Notified Body?
A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate.
What is notified body CE marking?
Notified Body – Medical Device CE Marking. A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate.