Medical Devices product certification

CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives and is a legal requirement to place a device on the market in the European Union.

As a Notified Body under the Medical Device Directives, BSI has the technical expertise and experience to provide CE marking services.

Conformity assessment service for medical device CE marking

The CE marking process can be a challenge for both smaller companies and global manufacturers. The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives in the EU.

In order to receive the designation in a timely manner and meet your market deadlines, you need a partner that understands how to help you build reliability into your CE marking project planning – resulting in efficient certification and speed to market.

There are four paths to obtaining the CE mark, and choosing the wrong one can be very costly and time consuming. Because we understand the conformity assessment process so well, we can determine which pathway is the most cost-effective solution for your device. And to add further efficiencies to the process, we can set up specific days for assessment or conduct an on-site review.

As a Notified Body under the Medical Devices Directives, we have one of the broadest scopes of any Notified Body.

  • The Medical Devices Directive (MDD) - all products
  • The Active Implantable Medical Devices Directive (AIMDD) - all products
  • The In Vitro Diagnostics Directive (IVDD)

This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is now a legal requirement, BSI has the technical expertise to assist and provide appropriate conformity assessment services.