Table of Contents
Is Intertek a Notified Body?
Our laboratory is accredited by SWEDAC and a Notified Body (No 0413) under the following EU directives: the EMC Directive, the Radio Equipment Directive and the Medical Device Directive. In addition, Intertek is one of the leading National Certification bodies in the CB scheme.
What is a CE Notified Body?
A Notified Body is a conformity assessment body that has been notified by a member state of the European Commission to carry out conformity assessment activities for a given directive. A Notified Body is assessed by the competent state authority in the directive for which it is notified.
What does Intertek ETL stand for?
Electrical Testing Laboratories
ETL stands for Electrical Testing Laboratories, the certification division of Intertek Testing Laboratories, who are also part of the NRTL program and provide assurance, testing, inspection, and certification services for a huge range of industries.
Why do you need a Notified Body?
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.
Do I need a Notified Body?
Generally speaking, a Notified Body assessment is usually required for products that need higher and stricter safety standards, or that weren’t build according to harmonized EN standards.
How can I check my CE certificate?
You can use the Nando database to search for a notified body that can certify your product. If your product doesn’t need to be verified by an independent body, then it is up to you to check that it complies with the technical requirements.
What is Intertek used for?
Intertek provides product safety testing and certification services for companies spanning multiple industries, markets, and applications.
Who is the Notified Body for medical devices?
Notified Bodies (NBs) – A Key Pillar of the Medical Technology Regulatory System. 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 Intertek medical notified body?
WHAT DOES THIS MEAN? Intertek Medical Notified Body (IMNB) offers certification to MDR. Information regarding the MDR application process is provided below. WHO CAN APPLY?
What is medical device CE marking?
After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Manufacturers can choose any notified body for conformity assessment (audit) regardless of which country the notified body is accredited. Medical device CE Marking consists of two stage audit.
Why choose Intertek for CE marking?
Intertek provides comprehensive Testing and Certification services and guidance through every step of the CE Marking process for Medical Devices In order for your products to be placed on the European market, they must meet the requirements of the relevant product directives.
Is our laboratory accredited by SWEDAC or Intertek?
Our laboratory is accredited by SWEDAC and a Notified Body (No 0413) under the following EU directives: the EMC Directive, the Radio Equipment Directive and the Medical Device Directive. In addition, Intertek is one of the leading National Certification bodies in the CB scheme.