Market access for medical devices

EU regulations and Swedish national legislation

Sweden is a member of the EU and thus the two EU regulations on medical devices (”MDR”) and on in vitro diagnostic medical devices (”IVDR”) apply in Sweden. All medical devices to be placed on the market and used in Sweden must fulfil MDR or IVDR , regardless of where they are designed and produced and by whom. This means that they must be CE marked. Regulatory compliance with legislations in other geographical regions or approval on other markets cannot replace CE-marking. 

For products that are manufactured one item at a time, each item becomes available for placing on the market individually. For products that are manufactured in batches, i.e. where several identical items are manufactured at the same time, all items in each batch instead become available for placing on the market at the same time. Placing on the market is therefore not the same as product launch.

There are transitional provisions which apply for medical devices that were placed on the EU market under the previous EU directives MDD, AIMDD or IVDD. This means that devices which were CE marked under the directives may still be placed on the market until the end of each transitional period, on condition that all transitional provisions are fulfilled. 

MDR and IVDR allow member states to have national legislation in certain areas, in addition to the requirements in MDR and IVDR. Sweden has national legislation for language requirements, which apply to all medical devices. The same national language requirements also applied under the previous EU directives.

The EU regulations can be accessed here, available in all official EU languages:

A compilation of all applicable legislation for medical devices in Sweden is available in Swedish:

Is it a medical device?

Determining whether a product is a medical device is called qualification. All products that meet the definition of a medical device according to the MDR or IVDR are medical devices. Products that do not meet these definitions are not medical devices.

Factors that determine the qualification of a product:

• the intended purpose, as expressed by the manufacturer (the person legally responsible for the product)
• the intended users
• to some extent the design, characteristics, functionality and components.

Note that the definitions may differ in some respects from definitions in other legislations. A product which is be registered and marketed as a medical device in other parts of the world may not always be qualified as a medical device in EU. 

Even if a product is not qualified as a medical device, other EU legislations and national legislation may still apply before it may be placed on the EU market, e. g. related to electrical safety, chemicals and general product safety.

Information on legislation for products other than medical devices is available from the National Board of Trade Sweden.

Roles and mandates

MDR and IVDR apply the so called “new approach”, making CE marking the route to market access. This means that the competent authorities do not have any role in review or approval of medical devices before they are CE marked and placed in the market. National registration or registration in the database Eudamed does not mean that any competent authority has reviewed or approved the device. 

The manufacturer is always responsible for regulatory compliance of the devices they place on the market through CE marking. This is called conformity assessment. See below regarding roles. For devices with higher risk classification, the manufacturer must apply to a notified body for conformity assessment, before the device can be CE marked. Devices in the lowest risk class are CE marked under the sole responsibility of each manufacturer, with no external assessment or verification. 

What does the Swedish MPA do?

The Swedish Medical Products Agency (MPA), is the Swedish competent authority for medical devices. Swedish MPA is responsible for market surveillance and supervision of actors who manufacture and/or market medical devices in Sweden and for their products. Swedish MPA is not responsible for decisions or recommendations on which medical devices are used in Sweden, their pricing, reimbursement or how they are used in Swedish healthcare. 

Swedish MPA can cannot provide regulatory guidance beyond general guidance and cannot answer specific questions related to if a certain device is compliant or how to ensure compliance for a specific device or situation.

Economic operators

MDR and IVDR list requirements for economic operators who handle medical devices, i. e. those who develop, produce or market such devices. Most requirements apply to the manufacturer.

Manufacturer

As defined in MDR and IVDR, a manufacturer of medical devices means “a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark”. This is not necessarily the same as the organisation which performs the actual physical production activities. In order to clarify this, the role is sometimes referred to as “legal manufacturer”.

Importer, distributor and AR 

MDR and IVDR also define the roles of importer, distributor and authorised representative (AR) and the responsibilities which come with each role. An organisation may have several roles but can only act in one role for each individual device unit.

The definitions of the roles differ somewhat from how these terms may be used in other settings and in daily language. As an example, the role of importer only applies to actors who import devices into EU/EEA from manufacturers located outside EU/EEA and place them on the union market. They are not necessarily importers in relation the customs legislation. 

The role as authorised representative is the legal EU representative for a manufacturer located outside EU/EEA and should not be misunderstood as related to a sales organisation (e.g. exclusively appointed distributors).

PRRC

All manufacturers and authorised representatives must have at least one person responsible for regulatory compliance (PRRC) within their organisation. Regulatory compliance refers to EU MDR or IVDR. This applies regardless of if the manufacturer is located within or outside of EU/EEA.

Use, users and requirements

MDR and IVDR do not regulate the use of medical devices or which users that may use them. However, during development and conformity assessment of medical devices the intended user(s) is an important factor to consider. Devices  shall be designed for their specific needs and skills, which may imply additional requirements than the ones in the regulation. 

Requirements and documentation

Before a medical device can be CE marked and placed on the market, the manufacturer must assemble documented evidence of compliance with all applicable requirements in MDR or IVDR. This collected documentation is referred to as the technical documentation. The clinical evaluation (MDR) or performance evaluation (IVDR) is an important part of the technical documentation. 

The manufacturer must also develop, implement and maintain a quality management system (QMS) in compliance with MDR or IVDR. Compliance with ISO 9001, ISO 13485 or other legislations is not sufficient in itself. 

Depending on parameters such as the risk classification and the intended users, MDR and IVDR give options for conformity assessment. For devices in higher risk classification, the manufacturer must go through assessment by a notified body, before the EU declaration of conformity is drawn up and CE marking is applied. The EU declaration of conformity must be available in Swedish or English for devices to be placed on the Swedish market.

Registration

Before placing the device on the market, the manufacturer must register the device. This must be done after the manufacturer has compiled all applicable evidence of conformity in the technical documentation, drawn up the EU‍ ‍declaration of conformity and affixed the CE‍‍ marking to the device.

Registration shall be made with the competent authority in the country where the manufacturer, or their authorised representative, is located. Please note that registration is an administrative task and does not mean that the competent authority will review or “approve” the device. 

The European database Eudamed is under development and therefore not yet mandatory to use. Until Eudamed is  mandatory to use, Swedish manufacturers and authorised representatives shall register their devices via the e-service provided on Swedish MPA’s website. Registration with Swedish MPA is mandatory in Sweden and comes with an annual fee. 

It is also possible to register your device in Eudamed on a voluntary basis, but this does not replace registration with the Swedish MPA. If a CE‍-‍marked device is already registered in another EU/EEA‍-‍member country where the manufacturer or authorized representative is located, no further registration with the Swedish MPA is required.

Reimbursement and recommendations on use of devices

The Swedish MPA does not handle decisions on reimbursement of medical devices (including IVD devices), nor do we issue recommendations to the Swedish healthcare system on which devices to use. There is no general nation-wide reimbursement programme for medical devices in Sweden.

Decisions on use and funding or reimbursement of medical devices are made by the regional authorities. Recently, an initiative has been started between the regional authorities for joint assessment and introduction of medical devices. 

For further information, please contact the responsible parties through their websites.

Two categories of medical devices are subject to a nation-wide reimbursement; 

1. devices needed by a patient to administer or control levels of prescription pharmaceuticals 
2. devices for stoma patients. 

Such reimbursements are handled by Dental and Pharmaceutical Benefits Agency (TLV), TLV also assist the regional authorities with health economic evaluations for the joint introduction initiative.

Further information at TLV’s website.