Medical Devices Directive 93/42/EC Evaluation and Testing
Replaced by the Medical Device Regulation 2017/745/EU (MDR)
Manufacturers must comply with the Medical Device Directive, MDD 93/42/EEC, in order to sell their medical products into Europe. F2 Labs can perform the EMC and Safety testing that is required by the Medical Device Directive for medical electrical products. With more than 20 years of experience in navigating the CE/IEC Certification process, you can count on us to get you through the process of Medical Device Directive testing.
Definition of Medical Device – Any instrument, apparatus, appliance, material, or another article, intended by the manufacturer to be used for a human being for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.
Contact F2 Labs today for assistance with required MDD 93/42/EEC certification testing, and get your medical device successfully into the European market.
Common Collateral & Particular Standards*
Medical Electrical Equipment -Part 1-12
* Please note: This is a partial list of collateral standards.