Navigating Medical Device Registration & Post-Market Surveillance in Sweden
Updated on: 23/01/2024
Overview:
Regulatory Authority:
The Medical Products Agency‘s goal is for users of medical devices to have access to safe devices that are suitable for their intended use.
The agency’s task is to carry out monitoring to ensure that relevant legislation in the medical device field is complied with. This monitoring will continue to take place via market surveillance through, inter alia:
The Medical Products Agency is responsible for reviewing planned clinical trials. The agency also conducts ongoing oversight of the designated notified bodies based in Sweden to ensure they are performing effectively and are retaining the necessary competence to undertake their designated activities.
The National Board of Health and Welfare is responsible for:
The Health and Social Care Inspectorate (IVO) supervises:
Link for Regulatory Authority: https://www.lakemedelsverket.se/en
Local Regulation:
Classification: Class I, IIa, IIb, III
Listing or Registration Requirements:
https://www.lakemedelsverket.se/en/medical-devices/manufacture/registration#hmainbody8
Special Labelling Requirements: Every user of a medical device in Sweden shall have access to information written in Swedish on the labelling and in the instructions for use. Information provided to the Authority shall be either in Swedish or English.
Reporting adverse reactions, events, and incidents
The National Board of Health and Welfare mandates that healthcare providers in Sweden report incidents involving medical devices to the Swedish Medical Products Agency (MPA). Reporting should be timely, rather than waiting for a comprehensive investigation. The initial report can be amended with latest information at a later stage, ensuring that the Swedish MPA and manufacturer are informed of any potential risks.
A notification shall be submitted if any of the below has led to, or could have led to, death or serious deterioration in someone’s health:
If you are unsure whether an event falls within the reporting requirements, you should inform the manufacturer and the Swedish Medical Products Agency of the occurrence anyway.
Notifications are submitted with an e-service. The e-service is only available in Swedish.
The healthcare provider must retain the device for further investigation, including its UDI/batch number/LOT number, usage instructions, and packaging. The manufacturer must have access to the device for investigation. If necessary, the provider must provide additional information to the manufacturer and the Swedish Medical Products Agency.
Additional Comments:
Who should make this communication:
When to make this communication: Before placing a medical device into the market.
How OMC Medical can assist you with the process
Why Choose Us
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
To launch a medical device in a country, medical devices must comply with the local country’s regulatory requirements. Let us be your trusted partner in bringing your medical devices to the Global market. Contact us today to learn more about how we can assist you in every step of the way.