The manufacturer is responsible for documenting that the regulatory requirements are met before a medical device can be placed on the market. This is called Conformity Assessment. A medical device that meets the requirements will have the CE mark as a visible proof that conformity assessment is performed.
The way to CE marking and placing on the market of a medical device
The Blue Guide gives a guidance on the implementation of EU product rules.
Is the product a medical device?
Evaluate whether the product meets the definition of a medical device (ref. Regulation on medical devices § 1-5 a) (lovdata.no)). Then, determine whether the product is a medical devices, in vitro diagnostic medical device or active implantable medical device.
Classify the medical device in accordance with applicable regulation. Active implantable medical devices are not classified.
Before a medical device can be placed on the market, the manufacturer must conduct a conformity assessment. Mainly this means to provide adequately documentation that the product is in conformity with the requirements of the regulation. The extent of the conformity assessment depends on the risk class of the medical device.
For a medical device in risk class higher than Class I the manufacturer must use a Notified Body to perform a conformity assessment. A Notified body is appointed by a national authority to conduct conformity assessments. Notified Body issues a certificate if the documentation for the medical device is sufficient. The certificate is part of the manufacturer documentation on the safety of the device.
A risk analysis for a medical device is the manufacturer’s basis for a systematic control of the risk related to the device. Construction, manufacturing method, labeling and instructions for use of the device are the basis for a risk analysis. This is also a tool to improve security after the product is placed on the market.
Norwegian language requirement
The label and the instructions for use shall be in Norwegian.
A Post Market Surveillance system for the medical device shall be established. The system must ensure that information about the medical device is systematically handled after placing on the marked. This makes it possible to identify need for product improvement. In addition a manufacturer surveillance system shall ensure that serious incidents and safety related corrective incidents are reported to the authorities.
Register in the Medical Device Database
Norwegian manufacturers and authorised representatives shall register all medical devices in the Medical Device Database before it is placed on the market.
CE marking and Declaration of conformity
Issue a written Declaration of Conformity that the product is in conformity with the regulation. The CE-marking is applied the medical device as a symbol that the product complies with the regulation.