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Dictionary:

Specific rules for medical devices

Does the study need to be notified to the Medical Products Agency?

Some clinical studies that involve medical devices need a permit from the Medical Products Agency. More information is available in the sections with specific rules for studies involving medical devices under the Idea and Planning tabs.

Some documents in the applications to the Ethical Review Authority and the Medical Products Agency shall be “mirrored”, such as the clinical trial plan (CTP). This means that these public authorities must approve the same version of these documents.

When a clinical study involving medical devices needs to be notified to the Medical Products Agency, the agency recommends that it follows “good clinical practice”. For medical devices, there is a harmonised standard, ISO 14155. More information on good clinical practice and ISO 14155 can be found under the Idea and Planning tabs.

Detailed application instructionsexternal link, opens in new window are available on the Medical Products Agency’s website. Application form and mandatory appendices shall be submitted electronicallyexternal link, opens in new window.

The appendices to the application are defined in the application form; in some cases it is recommended that they are designed according to ISO 14155. The standard includes required headings and contents for a number of documents. Among other things, the documents shall show that the trialled device is ready for a clinical study, that is to say the product fulfils the significant requirements in addition to the aspects covered by the study.

One of the appendices – “Declaration of conformity” – must be issued by the manufacturer. For a trial device, this means that the document must be designed according to Item 2.2 of Appendix 8 (Swedish Medical Product Agency’s regulations 2003:11 on medical devices). This is a confirmation that the device in question corresponds to the significant requirements (Appendix 1 of the Medical Products Agency’s Regulation LVFS 2003:11, or alternatively Annex 1 of the Medical Devices Directive), in addition to the aspects that constitute the purpose of the trials and that, in consideration of these aspects, all precautions have been taken to protect the health and safety of patients, users and other persons. Please note that his document is a different declaration of conformity than the one produced by the manufacturer for CE marking.

The Medical Products Agency then assesses whether the application is complete, and invoices an application feeexternal link, opens in new window. If the application is complete, the first administrative stage starts. This takes around one month, and thereafter the Medical Products Agency may ask for answers to a number of questions, and ask for additional information or changes. The application then goes through a second administrative stage, and is approved or rejected after no more than 60 days.

Corresponding requirements also apply in other countries – that is to say, a permit for the study must be applied for to the ethical review body of the country in question, and possibly to the country’s “authorised authority”. In addition, there are also other notifications, registrations and applications, just as in Sweden.