Regulatory framework for clinical investigations of medical devices

European legislation

The basic legislation is the same throughout EU and available in the EU regulation 2017/745 on medical devices (MDR).

The provisions that apply for clinical investigation of medical devices since 26 May 2021 are mainly found in MDR chapter VI (articles 62-82) and annex XV. Several of the definitions in article 2 of the MDR are also important to know for a correct application of the regulatory requirements.

In vitro diagnostic medical devices – according to IVDR

Information on the regulatory framework that applies to analytical and clinical performance studies based on EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR):

National legislation

The MDR allows the EU member states to regulate certain aspects nationally. The Swedish Parliament has adopted several laws to adapt national legislation to the MDR. Those most important for clinical investigations are:  

The act 2021:600 allows the government to regulate some aspects in more detail or delegate the responsibility to different authorities to issue provisions on these matters. The Swedish government has subsequently adopted such provisions in a national regulation and the Swedish Medical Products Agency has also issued provisions:

Previous national legislation, which to some extent is still applicable to clinical investigations authorised under the previous legislation:

The Act 1993:584 on medical devices

The Swedish Medical Products Agency’s regulations on active implants LVFS 2001:5

The Swedish Medical Products Agency’s regulations on medical devices LVFS 2003:11

The Act on Public Access to Information and Secrecy 2009:400.

The Declaration of Helsinki

Each step in the clinical investigation shall, according to the MDR, be carried out in accordance with recognised ethical principles. The recognised ethical principles are available in the Declaration of Helsinki. 

International standards

SS-EN ISO 14155:2020 (clinical investigations) and SS-EN ISO 14971:2020 (risk management) available via SIS (Swedish Standards Institute).

The European Commission guidance documents

Questions and answers regarding clinical investigations

Safety reporting in clinical investigations

Investigator’s Brochure

Clinical Investigation Plan

Summary of the clinical investigation report

Clinical evaluation