CE Marking for Medical Devices

CE Marking of Medical Devices or In-vitro Diagnostic Devices or Active Implantable means theat the manufacturer's declaration of that particular Medical Device complies with the essential requirements of the relevant European health, safety and environmental protection legislation, generally called as Product Directive.

It is the responsibility of the Medical Device manufacturers or distributors to make sure device sold in EU complies with the Medical Device Regulation (MDR) before affixing CE Mark and placing them on the European Market.  Failure to do so can result in sanctions such as removal of products from sale or use and in some cases prosecution.

Important information related to CE Marking of Medical Devices

Medical Device is a broad term used commonly. It includes Equipment, Surgical Equipment, Operation Theater Equipment, Surgical Instruments, Medical Software, Disposables, Home Health Care products, Medical reusable items etcetera.

Medical Device of CE Marking applicable for the following items:

The Devices manufactured for any of the following purposes: diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or replacement or modification of the anatomy, etcetera. It specifically excludes active implantable devices and in-vitro diagnostic devices which are covered by their own directives, but it includes any electronic apparatus such as personal computers (and their software) which are principally used for medical purposes.

The product category of CE Marking of Medical Devices falls apart in three classes:

•          Medical Software.(MD)
•          In Vitro Diagnostics (IVDs) and
•          Active Implantable (AIMDs).
•          Medicinal Products Directive (MP)
More details available when you continue reading our website.

Medical Device CE Marking Vs Medical Device Regulation (MDR) in brief

Like all New Approach Directives, the MDD requires that a medical product complies with a set of essential requirements relating to performance, health and safety. These requirements, focusing on the safety aspects of the design and construction, cover issues such as chemical, physical and biological properties, infection and microbial contamination, Electromagnetic, radiation, mechanical, thermal and electrical risks.

CE Marking of Medical Devices, its Regulation and Routes for Compliance

For all classification types, a Technical File must be prepared demonstrate compliance with MDR essential requirements.  Compliance can be established by showing conformity to the Harmonized Standards for the Medical Device CE Marking Directive. More details about CE Marking of Medical Device can be found in the inner pages when you continue reading website.

More information on Medical Device CE Marking can be found on the left side menu on this website.

Refer flowchart which explains the complete process of Medical Device CE Marking.

To calculate the cost of Medical Device CE Marking please click here

For a detailed quote, please fill the Request for Quote [RFQ] and submit online.


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