Arazy Group: Medical Device Regulation in EU

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How to Get CE Mark of a Medical Device

In order to get CE mark, you need to comply with one or more of the following requirements:

Establish and maintain a Medical Quality Management System (QMS)
Test your product in order to demonstrate compliance with applicable standards
Prepare a Technical File / Design Dossier for each family of products that you wish to obtain CE mark for.
Contract a European Authorized Representative.
Contract a Notified Body who will audit your Quality Management System and Technical Files / Design Dossiers.
Register your company and list your product with at least one European Competent Authority.

The actual requirements for your family of products are subjected to the classification of your devices. This classification is based on the level of risk your device contains.

Here are some examples of devices relating to product classification.

Description	CE Classification
Anesthesia machines	IIb
Bioactive implantable devices	III
Blood oxygen analyzers	IIa
Bone cements, with antibiotic	III
Brachytherapy devices	IIb
Catheters, angioplasty balloon	III
Catheters, with radioisotopes	III
Collagen implants	III
Condoms	IIb
Contact lenses	IIa
Contraceptive intrauterine devices (IUDs)	III
Corrective glasses	I
Crowns	IIa
Defibrillators, external	IIb
EEG and EMG Electrodes, non-invasive	I
Electrodes, neurocortical	III
Examination gloves	I
Extracorporeal Circulation Devices	IIa
Hemodyalizers.	IIb
Hospital beds	I
Incubators for babies	IIb
Infusion cannula	IIa
Infusion pumps	IIb
Lenses, intra-ocular	IIb
Lithotriptors	IIb
Lung ventilators	IIb
Muscle stimulators	IIa
Nebulizers	IIa
Needles, for syringes	IIa
Prosthetic heart valves	III
Scalpels	I
Shunts, carotid artery	III
Sterilizers for medical devices	IIa
Stethoscopes for diagnosis	I
Stomach pumping tubes	I
Stretchers	I
Sutures, absorbable	III
Syringes without needles	I
Ultrasound diagnostic equipment	IIa
Vascular stents	III
Wheelchairs	I
More examples…

If any of these examples is equal or similar to your type of products, take note of its classification and click on the corresponding blue button. If you are not sure, click on the Tell us what you need button and let us do the work for you.