CE Certification for Medical Devices

Medical Device Directives

Medical devices which are sold within the European Union market must comply with the requirements of one of the Directives:

• the Medical Devices Directive (MDD) 93/42/EEC,
• the Active Implantable Medical Device Directive (AIMD) 90/385/EEC,
• the In Vitro Diagnostic Device Directive (IVD) 98/79/EC.

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.

How can we help you?

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:

• Classifying your medical device;
• Performing Risk Assessments;
• Determining the applicable essential safety and health requirements for your medical devices;
• Product conformity testing;
• Conducting Factory Production Controls (FPC);
• Compiling and verifying Technical Files;
• Compiling and verifying User Instructions manual;
• Verifying and drafting EC Declarations of Conformity;
• Providing instructions on affixing the CE marking correctly;
• Conducting registration process for all Member States of the European Union.

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 +31 (0)36 202 4012
info@certification-company.com