Manufacturers Responsibility

The term "manufacturer" refers to the natural or legal person responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market. Devices can be placed on the market by the manufacturer himself or by another person on his behalf.

A person who assembles, packages, processes, labels or assigns the intended purpose of a medical device, which is placed on the market on his behalf, is also considered to be a manufacturer.

A device is considered to be placed on the market when it is transferred for the first time, physically or legally, from the manufacturer or importer to the user, or to the person who shall distribute the device, e.g. a retailer, whether the device is new or fully refurbished whether transferred for restitution or free of charge.

When a device is imported for personal use from a country outside EEA, the actual putting into service is considered to be equivalent to placing on the market.

CE-marking

The CE-marking of a device is information primarily directed towards the Competent Authorities and indicates that the device complies with the requirements in relevant legislation.

All medical devices, excepting custom-made devices and devices intended for clinical investigations, must bear the CE-marking in order to be permitted to be placed on the market.

The CE-marking does not mean that a device has necessarily passed assessment by a Notified Body or that the device is of a certain quality or possesses certain characteristics. It is the manufacturer who affixes the CE-marking to a device and whose responsibility it is to demonstrate compliance with the requirements.

The assessment of class I devices is performed by the manufacturer himself. If the device has a higher classification, the assessment must be performed in collaboration with a Notified Body.

Obligation to report

The manufacturer shall continuously monitor the performance of his devices in practical use. He is required to report every serious incident and near-incident caused by CE-marked devices. Serious incidents involving devices, or risk of such incidents, shall be reported by the manufacturer to Medical Products Agency within ten days if a death has occurred and within 30 days in all other cases. The rules and procedures for these reports are to be found in the Regulations LVFS 2001:8, and MEDDEV 2.12/1 Rev 4.

 

 
 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information