Application and notification – according to IVDR

The Investigator's Brochure (IB) shall contain information on the device intended for the performance study and available at the time of application/notification. The IB shall be designed according to Chapter I, section 2 in Annex XIV of the IVDR.

The Swedish MPA provides a template for the list referred to in Chapter I, section 2.7 of Annex XIV to the IVDR. It is not mandatory to use this particular template, it has been developed to facilitate for applicants who are to present the required information.

The IB should also fulfill the requirements in Annex C in the GSP standard ISO 20916:2019.

The Clinical Performance Study Plan (CPSP) shall be designed in accordance with sections 2 and 3 of Annex XIII to the IVDR and should meet the requirements of Annex B GSP standard ISO20916: 2019.

The declaration of conformity of an IVD medical device should be designed according to section 4.1, Chapter I in Annex XIV to the IVDR. The document must be signed by the legal or physical person responsible for the manufacturing of the medical device.

For the performance studies where applications and notifications are made to the Swedish MPA, the permit procedure is coordinated with the Swedish Ethics Review Authority.

In these cases, it is the sponsor (not the research principal) who applies for ethical review.

From 26 May 2022, the ethics application will be sent by the sponsor together with other documents to the Swedish MPA in a single package. This means that the ethics application should not be submitted separately via the Ethics Review Authority's application portal Ethix.

The Swedish Ethics Review Authority has produced an application form that is specific to clinical investigations of medical devices and performance studies. The form is available in Swedish on their website.

Upon receipt of the application or notification, the Swedish MPA forwards relevant parts of the submission dossier to the Swedish Ethical Review Authority as needed for their review according to the act SFS 2021:603 (in Swedish Lag med kompletterande bestämmelser om etisk granskning till EU:s förordningar om medicintekniska produkter).

Evidence showing that the investigators and investigational sites are capable of conducting the performance study according to the clinical performance study plan must be provided by sponsor.

The qualifications of the investigator shall be demonstrated by a CV, this is applicable for the principal investigator at each investigational site.

It should be confirmed by a certificate from the responsible person at each investigational site, that the site is capable of conducting the performance study.

Proof of insurance cover or indemnification of subjects in case of injury should be enclosed for each of the applicable health institutions together with any other specific insurances taken out by the sponsor for the performance study.

Attach the documents to be used to obtain informed consent, including patient information sheets and the informed consent form.

The content shall be designed in accordance with Article 59 of the IVDR and should comply with the requirements of ISO20916: 2019 section 4.5 and Annex F.

The documents must be written in Swedish.

The application dossier must contain a description of how information on protection and confidentiality in the processing of personal data is to be handled. The description shall state in particular:

• the organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed
• a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects.
• a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects.