Medical devices which are sold within the European Union market must comply with the requirements of one of the Directives:
Based on these Directives all medical devices must meet the applicable essential requirements on safety, performance and labeling and almost all must bear a CE marking. The fulfillment of the essential requirements has to be demonstrated by the manufacturer for all devices whether they are new devices or whether they have already been on the market in former times. Under the MDD there are no provisions for a “grandfathering” approach as known for example in the US.
Another important point of the MDD Directive is a compulsory authorised representative established in EU. Only manufacturers who do not have a registered place of business in Member State of the EU are obligatory to have an authorized representative. The main task of the representative is to liaise between manufacturer and Market Surveillance Authority as well as to keep Technical Files/Design Dossiers available to review by the Authority.
Certification Company is an expert in product certification and can be your authorized representative in EU. Our compliance specialists can perform complete CE certification of your devices in accordance with relevant Medical Directive.
Besides complete CE certification you can also contact us for the following services:
If you have any questions regarding
CE Certification, contact us directly at
+31 (0)36 202 4012 or
Please visit our Library to read more about Medical Device Directives.
The cost of CE Certification for medical varies by the assessment procedure. Request a quote to understand what your certification will cost.