Statutes and guidance documents

For clinical investigations conducted in order to create supporting documentation for the CE marking, the Act (1993:584) on medical devices, the Ordinance (1993:876) on medical devices, the Swedish Medical Products Agency’s regulations (LVFS 2001:5) on active implants and (LVFS 2003:11) on medical devices are in force. Information in the notification is subject to the Act on Public Access to Information and Secrecy (2009:400).

The investigation must be conducted in accordance with the current version of the Declaration of Helsinki and should comply with the documents adopted as Swedish standard SS-EN ISO 14155:2011 (clinical investigations) and SS-EN ISO 14971:2012 (risk management).

If a medicinal product, or a substance that is considered to be a medicinal product, is included in the investigation, the requirements in the Medicinal Act (1992:859) apply to the section concerning the medicinal product/substance.

If the device is manufactured using tissue that has originated from animals, the specific requirements regarding active implantable medical devices and medical devices in accordance with EU Commission Regulation No 722/2012 dated 8 August 2012 also apply.

Guidance documents that are published on the European Commission website for medical devices:
MEDDEV 2.7/1 Clinical evaluation: Guide for manufacturers and notified bodies

MEDDEV 2.7/2 Guide for Competent Authorities in making an assessment of clinical investigation notification

MEDDEV 2.7/3 Clinical investigations: serious adverse event reporting 

MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies

 
 
 

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