May 2021: Sweden Regulatory Update

Clinical Trials With Medical Devices: Application and Notification (MDR)

The Swedish Medical Products Agency, regulatory agency of Sweden, has posted a bilingual guidance document on May 11, 2021, to support applicants in completion of the application or notification of a clinical investigation of a medical device under the EU regulation 2017/745 on medical devices (Medical Device Regulation).

The document has 5 sections, wherein, Section 2 relates to the Clinical Investigation Description. The different fields covered under this section are scientific opinion, design, design methodology, development stage, objectives and endpoints, synopsis, planned enrollment, duration, population details, scope, investigator contact.

For more details, please refer to Clinical Trials with Medical Devices: Clinical Investigation Application Forms.

Leave a Reply