Sweden Medical Device Registration

Navigating Medical Device Registration & Post-Market Surveillance in Sweden

Overview

1. Applicability

• Registration is required for manufacturers, authorized representatives, and those assembling systems or procedure packs.
• Economic operators in Sweden and other countries must register if placing medical devices on the Swedish market or if relabeling or repackaging devices with the Swedish MPA.
• Economic operators outside Sweden do not need to register if already registered with a competent authority in another EU/EEA member state.

2.  Registration Requirements: Applicable to various categories of medical devices, including those CE marked according to different directives and risk classes, custom-made devices, systems, procedure packs, and national medical information systems (NMI).

3. Principles for Registration

• Separate registration for each role (manufacturer, authorized representative, etc.).
• Only one registration per role and organization (company registration number).
• Manufacturers, authorized representatives, and persons responsible for systems and procedure packs will transition to Eudamed when operational.
• Custom-made device manufacturers and NMI manufacturers will continue to register with the Swedish MPA even after Eudamed is operational.

4. Device Information

• Individual devices are not registered in the Swedish MPA’s register.
• Information on CE marked systems is not registered; only the number of devices at the UDI‍-‍DI level is stated.

5. Repackaging and Translation: Operators repackaging or translating must inform the Swedish MPA via the e-service and remain registered.

6. Registration Confirmation

• Confirmation of registration is sent automatically when the registration is correct.
• The confirmation does not include a list of CE marked systems.

7. Registration and Amendments

• E-services are used for both initial registration and amendments.
• Amendments may include updates, additions, or removal of information.
• Deregistration is required for operators completely stopping specific roles.

8. Deregistration

• Deregistration is done when activities within a specific role cease.
• It must be completed for one role at a time.

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:

• Follow-up of incidents and serious incidents (MDR)
• Follow-up of adverse events and serious adverse events (IVDR)
• Supervisory activities aimed at manufacturers and other economic operators

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:

• regulations on the use of medical devices in healthcare
• regulations on in-house medical devices.

The Health and Social Care Inspectorate (IVO) supervises:

• how medical devices are used in healthcare and in-house manufacture of medical devices.

Link for Regulatory Authority

https://www.lakemedelsverket.se/en

Local Regulation for Sweden Medical Device Registration

• Swedish Medical Devices Act
• EU MDR 2017/745
• EU MDR 2017/746

Classification of Medical Devices

Class I, IIa, IIb, III

Listing or Registration Requirements

• Economic operators outside Sweden do not need to register with the Medical Products Agency, and those registered with a competent authority in another EU/EEA member state must fulfill registration requirements when placing or making devices available in the Swedish market.
• If you sell national medical information systems (NMI) or repackaged devices in MDR/IVDR, you must register with the MPA.
• Since 26 May 2020, registration with the Swedish Medical Products Agency has been done via an e-service.

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:

• Malfunctions
• Deterioration in a device’s performance
• Inaccuracies in a device’s labelling or instructions for use

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.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk