Obtaining CE Certification for Medical Devices
CLASSIFICATION OF MEDICAL DEVICES
The classification of a medical device is the most essential part of the certification as this forms the basis for the path to take to conformity. A medical device is a very broad concept, e.g. a band aid is a medical device as well as a pacemaker. These devices all fall under the Medical Device Regulation. In order to distinguish these devices, they are classified in different risk classes. The risk classes are divided in Class I, IIa, IIb and III. A device in Class I is a device with low risk, and a device of Class III has a high risk. The classification is very dependable on the characteristics of the medical device.
Our services
OBTAINING A EC DECLARATION OF CONFORMITY FOR YOUR MEDICAL DEVICE
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Step 1
Identify EU requirements for your product
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Step 2
Assess level of conformity and testing
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Step 3
Assistance and review of the technical documentation
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step 4
CE Mark can be affixed and declaration of conformity is issued
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Step 5
Product is certified and can be traded in the EU
The benefits
Price and timeframe
Price ranges could vary based on the circumstances beforehand and therefore are given on request. The lead time is approximately two till four weeks depending on the given conditions. The timeframe and price are closely intertwined with the following factors:
- The applicable legal framework
- The availability of the technical documentation
- The degree of compliance