Notification and forms

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 Notification of clinical investigations

 Notification form

 Required appendices

 Other appendices

 Processing the notification

Good clinical practice

The Swedish Medical Products Agency (MPA) recommends that a clinical investigation of a medical device is carried out in accordance with the harmonised standard SS-EN ISO 14155:2011 Clinical investigation of medical devices – Good clinical practice. The standard describes a quality system that includes conduct, documentation and reporting. The fact that the standard is harmonised means that if it is followed there is, according to the EU Commission's decision, an assumption that the requirements in the Medical Device Directive are met in relation to the sections that the standard covers (see Annex ZA/ZB in the standard)

If the manufacturer/sponsor opts not to follow the standard, this must be justified and the documents in the investigation notification must report how an equivalent or higher level of quality is otherwise achieved.

As for clinical investigations of medical devices, the MPA applies the equivalent terminology in SS-EN ISO 14155:2011 regarding the various concepts for the investigators:

Principal investigator

Qualified person responsible for conducting the clinical investigation at an investigation site.
If a clinical investigation is conducted by a team of individuals at an investigation site, the principal investigator is responsible for leading the team.

Investigator
Individual member of the investigation site team designated and supervised by the principal investigator at an investigation site to perform critical clinical investigation-related procedures or to make important clinical investigation-related decisions.

Coordinating investigator
Investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation.

Notification of clinical investigations

A notification of a clinical investigation should be sent to the MPA in electronic format. Use online e-service (see link to the right) to electronically submit the notification form and the attachments directly to the MPA. The e-service is a pilot project within the MPA and only currently applies to clinical investigations of medical devices. The notification may also be submitted either as an attachment to an e-mail (limited size, 20 MB), DVD/CD or USB. The e-mail address for the MPA is registrator@mpa.se.

The files must not be password protected. Files in the following formats may be attached: pdf, doc, docx, xls, xlsx, tif, gif, txt, zip and jpeg. Only pdf versions from 1.4 to 1.7 are accepted. All pdf files should normally be created from electronic text documents (e.g. 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, i.e. the search function in applications such as Acrobat, Word and Excel can be used. Exemptions apply to those pages that have signatures that have been scanned.

Notification documents are submitted preferably in separate files as listed below, in terms of both the e-service and the files submitted by other means.
Notification documents must be in English or Swedish (see exceptions) and include the following elements:

Notification form

The form ”Notification form – Clinical investigation of medical devices” does not support the use of a Mac computer. Therefore the use of a PC computer with Microsoft Office Word version 2007 or later is required when filling in the form.

The information in the notification form is used by the MPA to determine whether the notification documents are complete and details the work that is necessary to review the notification. For a notification form and instructions, see the links to the right .

If the clinical investigation has been previously notified to the MPA or equivalent authority in another EU/EEA country and what is known as a CIV ID number (CIV-YY-MM-XXXXXX) has thereby been obtained from the EU Commission database for medical devices (EUDAMED), this number must be indicated on the notification form. If the investigation had not previously been assigned a CIV ID number, this will be given as part of the administration procedure at MPA and be notified to the manufacturer/sponsor.

Some of the information in the notification form will be entered into the EUDAMED database. For more information on EUDAMED see the link to the right.

The notification form is to be submitted in two different formats.

  1. Electronically completed form as document format docx (which allows forwarding of data to EUDAMED).
  2. The completed form is signed and scanned as a pdf (indicating sponsor/manufacturer/authorised representative's commitment concerning the clinical investigation).

Signatures including dating (scanned, not as original) are needed for the following documents:

  • Notification form (see above) signed by the manufacturer or the authorised representative or sponsor.
  • Declaration of conformity with the essential requirements signed by the manufacturer (chief executive officer or manager responsible for compliance with the essential requirements).
  • Investigation plan signed by the sponsor and the principal investigator or the national coordinating investigator if it is a multicentre clinical investigation. The signature pages may be scanned in this respect. (The investigation plan in its entirety is attached in a searchable format.)

Required appendices

  • Invoice documentation
  • Clinical investigation plan
  • Clinical investigator's brochure
  • copy of insurance coverage/information on insurance protection for the test subject
  • patient information, form for the test subject's consent to participate in the investigation as well as forms for the test subject's consent for the disclosure of medical record data (all parts in Swedish) 
  • copy of the Ethical Review Board's statement and details of the aspects covered, if they are available when the notification is submitted. Otherwise, a copy of the application to the Ethical Review Board is submitted.
  • list of the Swedish investigation site(s) and principal investigator(s), if not specified in the investigation plan
  • evidence of competence of the coordinating investigator and the principal investigator for each investigation site
  • declaration of conformity with essential requirements

Other appendices

The MPA also regularly asks for the following documents:

  • intended labelling of the investigation device
  • user manual for staff (Swedish/English text) and/or as required for test subjects (Swedish)
  • a copy of the application to the Ethical Review Board

Documents where applicable or that the MPA may request:

  • results of the risk assessment or assessments (usually included in the investigator's brochure) or specific risk assessment or assessments with associated reading instructions/code keys including documentation of the risk management
  • list of standards applied in full, and a description of deviations from the standard where the standard is a harmonised EN standard (usually included in the investigator's brochure)
  • design drawings, and diagrams of components, sub-assemblies, wiring diagrams, etc., and intended methods of manufacture, in particular in respect to sterilisation
  • documentation in accordance with the Commission Regulation (EU) No 722/2012 if the investigated device is manufactured of tissues from animals
  • documentation if the investigated device contains substances derived from human blood
  • documentation if the investigation device contains, as an integral part, a substance which, if used separately, can be considered as a medicinal product (copy of scientific opinion that the notified body has received from a competent authority for the substance in question)
  • documentation of the medical devices/medicinal products/substances which the investigational medical device will be used together with or compared to in the clinical investigation (usually included in the investigation plan)
  • form for recording data (Case Report Form)
  • evaluation form to be completed by the test subject or staff (in Swedish)

Processing the notification


Initially, the MPA makes a review of the attached documents. This is a validation confirming that all the documents required in a notification have been submitted. The validation is made within three working days. If any documents have been omitted, this must be justified in full. The processing time (maximum 60 days) is counted from the date the notification is deemed valid. If the MPA finds that the notification is incomplete, the sponsor will be notified to this effect. The processing time is counted from the date on which all additional documents have been registered with the MPA and the notification has been deemed valid.

The MPA acknowledges receipt with a letter containing a reference number and when the processing time begins. The invoice is sent from the Department of Finance and Budget at the MPA.

During the processing time, any discrepancies in the notification are identified. The MPA gives the sponsor one opportunity of submitting a supplementation to correct the discrepancies. This supplementation must be with the MPA within ten days. If the sponsor requires more than ten calendar days, there is the option of withdrawing the notification in order to submit a new notification later.

In the renewed notification (resubmission), the MPA's requirements for additions and amendments must be met and complete documentation must be resubmitted. A new processing time of 60 days begins and the investigation notification gets a new reference number.

If the MPA in its assessment finds that the clinical investigation can begin, the MPA notifies the sponsor of its position. Special commissioning decisions are not issued beyond this.
If the notification still contains discrepancies after the supplementation that warrant that the investigation cannot be accepted, the MPA will notify the negative decision within 60 days of the notification being deemed valid.

The investigation may start when the MPA has notified that there are no objections to the investigation beginning, and that the Ethics Review Board has approved the investigation.

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information