Application and notification
- Published: December 16, 2019
- Last updated: May 27, 2024
According to the MDR the sponsor is to submit applications and notifications to the authorities via the European database on Medical Devices (EUDAMED). This functionality in EUDAMED is however not yet available. In the meantime, applications and notifications of clinical investigations are therefore handled nationally.
In Sweden, applications and notifications regarding clinical investigations of medical devices shall be sent to the Swedish Medical Products Agency (Swedish MPA).
The submission should be done in electronic format, preferably by the online e-service. Email, USB or DVD/CD may also be used.
Regardless if an investigation shall be notified or if an application is required for an authorisation from the Swedish MPA, the same documentation shall be submitted to the Swedish MPA.
Technical prerequisites
Submission by email has a size limit of 20 MB per message.
Documents are to be submitted as separate files, regardless of transmission method used. Documents must be in English or Swedish.
- Files in the following formats may be submitted: pdf, doc, docx, xls, xlsx, tif, gif, txt, zip and jpeg. The files must not be password protected.
- All pdf files should be created from electronic text documents (for example Word).
- To facilitate the review, applicants should ensure that all pdf files allow text to be copied and are fully editable.
- All files should be fully searchable, in other words, the search function in applications such as Acrobat, Word and Excel can be used.
- Exemptions to searchability applies to scanned pages with signatures.
E-service for application and notification
E-service for application:
Clinical Investigation Application Forms
The application form shall be used both for applications and notifications of clinical investigations to the Swedish Medical Products Agency.
The Swedish Medical Products Agency has written a bilingual guidance document to support applicants in completion of the form.
Certain sections of the application form are provided as separate files, to be used if needed:
Section 3 – Additional investigational device(s): The main application form has room for only one investigational device. If there is more than one investigational device in the clinical investigation, details have to be provided on each of them. Use as many additional section 3 forms as needed.
Section 4 – Additional comparator device(s): The main application form has room for only one comparator device. If there is more than one comparator device in the clinical investigation, details have to be provided on each of them. Use as many additional section 4 forms as needed.
Section 5 – Additional investigation site(s): The main application form has room for only seven investigation sites. If there are more than seven sites in the clinical investigation, use as many additional section 5 forms as needed.
Required documents
Investigator’s Brochure
The investigator's brochure shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of submission. The Investigator’s Brochure shall be designed according to MDR section 2 in Chapter II, Annex XV.
A template for the list referred to in section 2.7 of Chapter II, Annex XV of the MDR can be downloaded from an EU guidance document that is published on the EU Commission’s website (the template ‘GSPR and list of standards applied' is located in the Annex of the guidance).
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 investigator’s brochure also should fulfil the requirements in Annex B in the GCP standard SS-EN ISO14155:2020.
Exception: If the clinical investigation concerns a CE marked device which is being studied within the scope of the intended purpose, the Investigator’s brochure may be replaced by the Instructions for use issued by the manufacturer.
Clinical Investigation Plan
The clinical investigation plan should be designed according to MDR section 3 in Chapter II, Annex XV and should fulfill the requirements in Annex A in GCP standard SS-EN ISO14155:2020.
There shall be a synopsis of the Clinical Investigation Plan in Swedish.
Declaration of conformity
The declaration of conformity of an investigational product should be designed according to MDR section 4.1 in Chapter II, Annex XV. The document must be signed by the legal or physical person responsible for the manufacturing of the investigational product.
Exception: If the clinical investigation concerns a CE marked device which is being studied outside the scope of the intended purpose, a sponsor who is not the manufacturer of the device may be exempted from the requirement to submit a Declaration of conformity signed by the manufacturer.
Such an exemption is only allowed if the Investigator’s brochure fulfils the particular requirements that are provided in the Swedish MPA provisions (Läkemedelsverkets föreskrifter (HSLF-FS 2021:32) om kompletterande bestämmelser till EU:s förordning om medicintekniska produkter – available in Swedish only).
Application to Swedish Ethical Review Authority
The Swedish MPA and the Swedish Ethical Review Authority coordinate the national authorisation procedures for all applications related to clinical investigations of medical devices.
From the 26th of May 2024 the national coordinated procedure applies also for all notifications related to clinical investigations, irrespectively if the investigation is falling under article 74(1) or article 82 of the MDR. The ethics application is submitted by sponsor together with the application to the Swedish MPA in a combined submission dossier. The ethics application should therefore not be submitted via the Ethical Review Authority’s system Ethix.
What the ethics application should contain can be found on the Ethical Review Authority’s website (in Swedish):
There is also the specific application form to be used for clinical investigations of medical devices available.
Upon receipt of the application or notification, the Swedish MPA forwards relevant parts of the submission dossier to the Ethical Review Authority as needed for their review according to the act SFS 2021:603 (Lag med kompletterande bestämmelser om etisk granskning till EU:s förordning om medicintekniska produkter).
Documentation regarding investigator and investigational site
Evidence showing that the investigators and investigational sites are capable of conducting the clinical investigation according to the clinical investigation 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 clinical investigation.
Proof of insurance coverage or indemnification
Proof of insurance cover available at each of the applicable health institutions should be enclosed together with any other specific insurances taken out by the sponsor for the particular investigation.
Patient information and informed consent form
The content shall be designed according to MDR article 63 and should fulfill the requirements in SS-EN ISO14155:2020 sections 5.8.4 and 5.8.5.
The documents must be written in Swedish.
Description of personal data protection
The clinical investigation plan or a separate document shall describe in particular:
- 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.
Invoice details
Investigations involving biological samples from humans
If a clinical investigation involves use of biological samples from humans, the Swedish MPA will forward relevant documents in the application/notification dossier to the concerned biobanks/Regional biobank centres. This concerns situations where the Swedish Biobank Act (2023:38) is applicable to the clinical investigation.
The purpose with this sharing of information is that a regional biobank centre can assess the underlying documentation related to biological samples from humans in parallel to the review made by the Ethical Review Authority and the Swedish MPA. If there is a need from a biobank perspective to amend the application/notification, this can be dealt with during the authorisation procedure, so that basically only formal sign off of the biobank agreement remains once the investigation has been approved by the Ethical Review Authority and/or the Swedish MPA.
It is important that the biobank application, if applicable, is submitted to the Regional Biobank Centre at the same time as the application/notification of a clinical investigation is made to the Swedish MPA.
Information and support in relation to the biobank process (in Swedish):