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?

Get free quote

‘It was a pleasure to work with Certification Experts. After reviewing our documentation, they gave us structured feedback and showed us a way forward to compliance with EU directives.’

Technical Director

‘We found the collaboration with the CE Team very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required. In the future, CE will stay our choice if expert-know-how is needed.’

GM Service & Support

‘The test results during the certification project were comprehensive and detailed. We experienced this as a pleasant and valuable result. In addition, Certification Experts swiftly came up with solutions for obstacles we encountered during the certification process.’

Founder & CTO

“CE is our partner for over 10 years and the relationship is outstanding. The face-to-face meetings are really important and safe us a lot of time.

Engineer Manager

“The team of Certification Experts consists of nice people, it was a good cooperation! For me it was important how they made everything clear and how they thought along the same lines.”

Managing Director

“Personally I am very satisfied with the service and quality of the work of Certification Experts. With future projects, I certainly intend to work with them again.”

CEO

“The collaboration with Certification Experts runs smoothly and they are a valuable partner for us. If Dutch companies require specific technical information about the Comprehensive Economic & Trade Agreement on free trade, Certification Experts is the first to call.”

Trade Commissioner

“The cooperation with CE goes satisfactorily. They were decisive from the start and things were well taken care of. I see the problem-solving capacity of Certification Experts as a strength of the company.”

Quality Coordinator