Obtaining CE Certification for Medical Devices

Have you finished designing, developing, and manufacturing, and is your product 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 declare that the medical device is in compliance with all legal requirements of the European market. The Medical Device Regulation (EU) 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.

MEETING THE EU MEDICAL DEVICE REGULATIONS

As responsible entity you have to ensure that your medical device and its documentation meet the EU medical device directive. Where do you start? Every case is different and has its own unique characteristics. We have years of experience in medical product certification in the EU and internationally, and  offer swift and tailored certification of your medical device. Our consultants have complete knowledge of the EU’s medical device classification standards, so if you are unsure whether your product is classified as a medical device in Europe, we can confirm for you. With our certification process, we guarantee your medical device and documentation will meet all mandatory provisions. All we need is specific information of the medical device and we will arrange the rest.

Have you finished designing, developing, and manufacturing, and is your product 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 declare that the medical device is in compliance with all legal requirements of the European market. The Medical Device Regulation (EU) 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.

MEETING THE EU MEDICAL DEVICE REGULATIONS

As responsible entity you have to ensure that your medical device and its documentation meet the EU medical device directive. Where do you start? Every case is different and has its own unique characteristics. We have years of experience in medical product certification in the EU and internationally, and  offer swift and tailored certification of your medical device. Our consultants have complete knowledge of the EU’s medical device classification standards, so if you are unsure whether your product is classified as a medical device in Europe, we can confirm for you. With our certification process, we guarantee your medical device and documentation will meet all mandatory provisions. All we need is specific information of the medical device and we will arrange the rest.

 
Product Certification Approval CE Mark
Set the date for your market access

CLASSIFICATION OF MEDICAL DEVICES

The classification of a medical device is the most essential part of the certification as this forms the basis for the path to take to conformity. A medical device is a very broad concept, e.g. a band aid is a medical device as well as a pacemaker. These devices all fall under the Medical Device Regulation. In order to distinguish these devices, they are classified in different risk classes. The risk classes are divided in Class I, IIa, IIb and III. A device in Class I is a device with low risk, and a device of Class III has a high risk. The classification is very dependable on the characteristics of the medical device.

Our services

  • CE Marking process
  • Technical File review
  • Medical Device testing
  • Affiliated Notified Body services
  • EC Declaration of Conformity
  • User manual and Labelling
  • ISO:13485 Implementation

OBTAINING A EC DECLARATION OF CONFORMITY FOR YOUR MEDICAL DEVICE

  • Step 1

    Identify EU requirements for your product

  • Step 2

    Assess level of conformity and testing

  • Step 3

    Assistance and review of the technical documentation

  • step 4

    CE Mark can be affixed and declaration of conformity is issued

  • Step 5

    Product is certified and can be traded in the EU

The benefits

Accelerate market access

We'll do the job on-site around the globe

Short and flexible lead time

Consult our Medical Device experts

Assurance of compliance

Avoid liability risks and legal issues

Knowledge sharing

Gain experience and insight by training

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
 

Receive our offer today

Our team will offer a tailor-made solution based on your specific needs.