Regulatory framework for performance studies – according to IVDR

European and national legislation needs to be read together for a complete picture of the legislation in Sweden. The guidance documents and international standards published are intended to facilitate the interpretation and practical application of the legislation.

European legislation

Performance studies of IVD – according to IVDR

Since 26 May 2022, an EU-common regulation for in vitro diagnostic medical devices (IVD) and accessories for in vitro diagnostic medical devices, 2017/746 (In Vitro Diagnostic Regulation, IVDR) applies. This Regulation contains the basic legislation that is common to all EU Member States and countries that are part of the European Economic Area (EEA).

The provisions applicable to performance studies of IVD medical devices are found in Chapter VI (Articles 56 to 77) and Annexes XIII and XIV to the IVDR. Several of the definitions in Article 2 of the IVDR are also important to known for a correct application of the regulatory requirement.

Medical devices – according to MDR 

Information on the regulatory framework that apply to clinical investigations of other medical devices based on EU Regulation 2017/745 on medical devices (MDR):

National legislation 

The IVDR allows the EU and the EEA countries to regulate certain aspects nationally. The Swedish Parliament has adopted on amendments to several laws to adapt Swedish law to IVDR.

Most important for performance studies are (all documents are in Swedish):

Act 2021:600 in turn allows the Swedish 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 (MPA) has also issued provisions. The following acts will be updated shortly.

For the performance studies started before 26 May 2022, the Swedish MPA regulations (LVFS 2001:7) on medical devices for in vitro diagnostics apply. There are currently no requirements in these regulations for any performance studies of IVD products to be reported to the MPA.

The Declaration of Helsinki 

According to the IVDR, each part of the performance study shall be performed in accordance with accepted ethical principles. The ethical principles referred to are contained in the Declaration of Helsinki.

International standards

ISO 20916:2019 (clinical performance studies) and SS-EN ISO 14971:2020 (risk management) available via Swedish Standards Institute (SIS).

Guidance documents 

Safety reporting in performance studies

Q&A – In vitro diagnostic medical devices in clinical trials

Clinical evidence for IVD medical devices