When a medical device is CE-marked this is an assurance by the manufacturer that the device will perform as stated and that the clinical benefit of the device outweighs any side effects when it is used for the intended purpose and in the intended way.
The documentation underlying this assurance shall include a clinical evaluation. The evaluation shall be based on clinical data obtained from relevant scientific literature and/or clinical investigations.
Clinical investigations shall be undertaken only when necessary information concerning the performance, safety and clinical benefit of the device cannot be obtained by other means than testing it on human beings. At the same time clinical investigations may be necessary irrespective of the risk classification of the device.
In case of uncertainty on the obligation to notify, please consult the Agency.
Regulations and guiding documents applicable to clinical investigation of medical devices
The legal requirements relating to clinical investigations conducted in order to establish support for CE-marking are set out in the Swedish Medical Devices Act ( SFS 1993:584) and Medical Devices Ordinance (SFS1993:876), the Medical Products Agency statutes books LVFS 2001:5 (the Swedish implementation of Directive 90/385/EEC) and LVFS 2003:11 with amendment LVFS 2004:11 (the Swedish implementation of Directive 93/42/EEC) and legislation regulating the work of healthcare professionals in Sweden.
Information in the notification documents is covered by the Swedish Confidentiality Act ( SFS 1980:100).
The investgation shall be carried out in accordance with the latest edition of the Helsinki Declaration and should follow as Swedish standard adopted SS-EN ISO14155-1 & 2 (clinical investigations) and SS-EN ISO 14971 (risk management).
When a medicinal product or a substance perceived as a medicinal product is involved in the investigation, the Swedish regulations on medicinal products apply in parts that concern the medicinal product/substance.