CE marking for medical devices in accordance with the Medical Device Regulation

Are you finished with designing, developing, manufacturing and ready to enter the market? When trading medical devices on the European market, obtaining the CE-mark is mandatory for every company or entity. With the CE-mark you will declare that the medical device is in accordance with all legal requirements of the European market. The Medical Device Regulation 2017/745 is a set of requirements and processes for you as responsible party. When your medical device is in accordance with this set of requirements, the CE-mark can be affixed and the medical device can be legally introduced to the European market.

Solutions for legal market access

As responsible entity you have to ensure the medical device and its documentation are clear-cut and waterproof. Where do you start? Every case is different and has its own unique characteristics. Therefore, we offer a swift and tailored certification of your medical device. With this certification process Certification Experts guarantees your medical device and documentation meet all mandatory pro

The certification process

We based our process approach on the basic need of our clients. The certification process is a comprehensive set of steps in which we carefully follow our standard guideline for the realization of market access.

  • Step 1

    Identify EU requirements for your machine

  • Step 2

    Assess level of conformity and testing

  • Step 3

    Risk Assessment of the machine  

  • Step 4

    Assistance and review of the technical documentation

  • Step 5

    Machine is certified and can be traded in the EU

Benefits of Service

  • Realizing easy market access
  • Short and flexible lead times
  • Knowledge sharing for future certification

Price and timeframe
Price ranges could vary based on the circumstances beforehand and therefore are given on request. The lead time is approximately two till four weeks depending on the given conditions. The timeframe and price are closely intertwined with the following factors:

  • the applicable legal framework
  • the availability of the technical documentation
  • the degree of compliance

Do you want to know the price and timeframe for the certification of your medical device?

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