Registration of operators and devices
- Published: January 25, 2021
- Last updated: May 31, 2021
Until Eudamed is in place, registration of economic operators established in Sweden and their devices must take place with the Swedish Medical Products Agency (Swedish MPA).
E-services
E-services for registration and amendments of the registration can be found under the tabs for each operator below. An e-service for deregistration of operator roles can be found at the bottom of the page.
It is important to read all the information below for a successful registration.
Registration applies to manufacturers and authorised representatives who place medical devices and/or systems or procedure packs on the market in accordance with relevant regulatory frameworks. Operators established in Sweden and other countries shall register the placing on the market of NMI or the making available of devices which have been relabelled or repackaged with the Swedish MPA.
Important note to economic operators outside of Sweden
If you are an economic operator established outside of Sweden, you generally do not need to register with the Medical Products Agency. If you are registered with the competent authority in another member state in the EU/EEA the requirements on registration is fulfilled also when placing devices, or making devices available, on the Swedish market.
If you place national medical information systems (NMI) on the market or make devices which have been relabeled or repackaged (according to the provisions in article 16) available on the market in MDR/IVDR, you shall register with the MPA
Please note that there are other national requirements that may need to be considered, such as information according to paragraph 13 in annex 1 to the MDD/paragraph 23 in annex I to the MDR shall, where applicable, be provided in Swedish.
Introduction
Since 26 May 2020, registration with the Swedish Medical Products Agency has been done via an e-service.
Registration must be done by all operators which run businesses involving medical devices which are subject to registration that comply with the Swedish implementation of the MMD/AIMDD/IVDD directives, EU Regulation MDR/IVDR or national medical information systems (NMI) in accordance with national regulations.
More information can be found further down on which operators and business must register themselves.
No registrations completed before 26 May 2020 have been transferred automatically. To maintain the registration with the Swedish MPA without interruption, all operators should have carried out a registration via the e-service no later than 30 September 2020.
Confirmation of registration will be sent when the registration has been verified as correct.
Registration requirements
Economic operators established in Sweden subject to the requirements on registration:
- manufacturers
- authorised representatives
- anyone assembling systems or procedure packs and places them on the market
Economic operators established in Sweden or other countries subject to the requirements on registration:
- manufacturers of national medical information systems (NMI)
- distributors and importers responsible for relabelling/translation or repackaging according to the provisions in article 16.2-16.4 in MDR
The requirements apply to the following categories of medical devices, accessories to medical devices and products:
- devices CE marked according to MDD
(devices that are subject to the transitional provisions in MDR, “legacy devices”) - devices CE marked according to MDR
(all risk classes) - devices CE marked according to IVDD
(all types) - devices CE marked according to IVDR
(all risk classes) - custom-made devices
- systems or procedure packs
- national medical information systems (NMI).
Registration with the Swedish MPA does not mean that the Swedish MPA has authorised the devices. It is the operators who are responsible for ensuring that the devices covered by the registration comply with applicable requirements in the regulatory framework.
The Swedish MPA is responsible for market surveillance of the medical devices that are placed on the market.
Principles for registration
A separate registration must be made for each role. The various roles are as follows:
- manufacturer of CE marked devices
- person responsible for systems and procedure packs
- authorised representative for manufacturer of CE marked devices
- manufacturer of custom-made devices
- manufacturer of national medical information systems (NMI).
An organisation (legal or natural person) may need to make several registrations if the organisation performs several roles.
It is only possible to have one registration per role and organisation (company registration number). Separate units within an organisation must not be registered separately.
See information specific to regions and municipalities below.
Manufacturers of CE marked devices, authorised representatives and persons responsible for systems and procedure packs must only be registered in the Swedish MPA's register until Eudamed becomes operational, when they will need to register themselves and their devices in this system.
Manufacturers of custom-made devices and national medical information systems (NMI) will continue to register with the Swedish MPA even once Eudamed is operational, which is expected to be 26 May 2022.
Individual devices are not registered in the Swedish MPA’s register
One change is that information on individual CE marked systems will not be registered. Only the number of devices must be stated in the e-service (at the level corresponding to a UDI-DI in the MDR) for each combination of risk class and category of device, more on this can be found under the role tabs.
Repackaging and translation
Operators (distributors or importers) which repackage and/or translate labelling and/or information in accordance with Articles 16(2) to 16(4) of the MDR must inform the Swedish MPA of this activity via the e-service.
The operators must also continue to be registered in the Swedish MPA's register.
Information for regions and municipalities
Only one registration may be made per organisation (company registration number) and role. This means that different businesses, units or departments that belong to a region or municipality and come under the region’s/municipality’s company registration number must be notified centrally from the organisation concerned.
Operators, such as some hospitals, which have their own organisation number are registered independently from the region/municipality.
If you belong to an operator in a region or municipality, you will therefore need to find out whether the business has its own organisation number or whether you need to coordinate within the region/municipality to ensure that the registration is correct.
Independent operators which are associated via an agreement with the region or municipality must be registered separately.
Registration confirmation
Previous registration certificates are replaced by a confirmation of registration which is dated with a date of issue but has no expiry date. The confirmation of registration does not include a list of the CE marked systems that have been registered.
The confirmation is automatically sent when the registration is correct. The confirmation may be delayed if any information is missing or manual verification is required. If the registration needs to be supplemented, you will be contacted by the Swedish MPA.
Registration and amendments of registration with e-services
Prepare and complete your registration
- Prepare yourself well, with all information for a trouble-free registration and confirmation,
- if you take a break for longer than an hour while filling in the registration, all data which has been entered will be lost,
- the tabs reflect the various roles that exist for registration. If you act in more than one role, you will need to repeat the procedure for each role,
- in each tab you will find the link to the e-service and the information you must enter when registering that role.
- save the confirmation e-mail from the e-service to keep track of the submitted information in order to determine when you need to amend your registration.
Prepare and complete your amendments of registration
You shall keep the registered information up to date and may therefore need to make amendments to the information in your registration. An amendment may entail that you update (change) information, add information or remove information.
You are required to submit basic contact information with your request for amendments: organisation number/personal identity number, company name and name and email address of the person submitting the request.
Furthermore:
- in each tab you will find the link to the e-service which information that can be amended.
- you shall on enter data in fields that shall be amended
- if a field is left empty, the previously registered data is preserved
- entire pages of data fields may have to be left empty if no data are to be amended.
Categories of devices according to EMDN
One aspect which may need to be explained in more detail are the categories of device according to European Medical Device Nomenclature (EMDN). For many of the roles, the category of device must be stated for registration in the Medical Products Agency's register, and this is done using the categories from EMDN.
EMDN will be used for registration in Eudamed and will build on the Italian CND nomenclature. The European Commission is currently working on revising CND in order to create the first version of EMDN. Among other things, they are working on a translation function between GMDN and EMDN which will be integrated into Eudamed.
The Medical Products Agency has chosen to use EMDN as a basis for the categories of device in the national register.
In order to register CE marked devices as a manufacturer or authorised representative, as well as systems and procedure packs in the Medical Products Agency's register, information is required regarding what categories the devices subject to registration belong to. This is indicated by the categories in the highest level of the CND nomenclature. They are described in the document entitled ‘The CND nomenclature’. A full version of EMDN has not yet been published, and there are also no published guidelines.
Considering that several important documents are still missing, the Medical Products Agency understands that it is not always entirely simple to allocate the correct categories of device.
The Medical Products Agency requests that you complete the main content correctly to the best of your ability. Some guidance may be provided by the CND structure in the Excel list of current CND nomenclature. Please note that the list should not be seen as the final EMDN which may look different.
Manufacturers of CE marked devices
Please note that the e-service is adapted both to the directive-based legislation and to the EU’s MDR/IVDR regulations.
As a manufacturer of CE marked devices, you must prepare the information listed below.
Information on the company
Organisation number and company name must be stated exactly as they are registered with the Swedish Companies Registration Office/Swedish Tax Agency. If the information deviates from what is registered, this will lead to manual processing, which will cause the registration to take longer to be confirmed.
- organisation number/personal identity number
- company name
- delivery address
- email and telephone number of the company
- name, email address and telephone number of a contact person
- geographical address.
Invoicing information
- Billing address (can be the same as delivery address)
- Peppol ID or GLN and VAN for electronic invoices in Peppol or Svefaktura format.
If the company has previously received invoices from the Medical Products Agency, you must select ‘The Medical Products Agency already has the company’s invoicing information’. If the Medical Products Agency does not have the information, the invoice will be sent to the delivery address.
Number of devices
Number of devices (at the level equivalent to a UDI-ID according to the MDR) of a certain combination of category and class of device. Read more about how the categories of device are stated according to EMDN in the tab above.
If you have devices from one category of device but in several different risk classes, or vice versa, a number needs to be stated for each combination of class and type.
Examples of different combinations of type and class that must be registered separately:
|
Category |
Risk class |
|
L: Reusable surgical instruments |
MDD klass I |
|
L: Reusable surgical instruments |
MDD klass Is |
|
L: Reusable surgical instruments |
MDR klass I |
|
|
|
|
V: Medical devices – various |
MDD klass I |
|
V: Medical devices – various |
MDR klass I |
|
Q: Dental, ophtalmologic and ent devices |
MDD klass I |
|
|
|
|
W: In vitro diagnostic devices |
IVDD generell |
|
W: In vitro diagnostic devices |
IVDD självtest |
|
W: In vitro diagnostic devices |
IVDD lista A |
|
W: In vitro diagnostic devices |
IVDR klass B |
Field in the e-service
In the e-service, there is a field where you can fill in the name of the person responsible for regulatory compliance.
This does not need to be completed in the case of the manufacture and placing on the market of devices according to the MDD/AIMDD/IVDD; continue without filling in the information.
Transfer to MDR/IVDR
If you register devices according to the MDD/AIMDD/IVDD and then start to manufacture and place devices on the market according to the MDR/IVDR, you must remember to:
change the categories and classes of the devices — classes differ between directives and regulations
register a person responsible for regulatory compliance.
Possible amendments
All information on the company, invoicing information and information on the person responsible for regulatory compliance may be changed or added.
Information on the number of devices of a certain combination of device category and risk class may be changed, added or removed. If the number is changed, please state the updated total number.
Link to e-service
Choose the operator role ‘Manufacturer of CE marked devices’ in the e-service.
Authorised representative for manufacturer of CE marked devices
Please note that the e-service is adapted both to the directive-based legislation and to the EU’s MDR/IVDR regulations.
As an authorised representative (AR) for a manufacturer of CE marked devices, you must prepare the following information.
Information on the company
Organisation number and company name must be stated exactly as they are registered with the Swedish Companies Registration Office/Swedish Tax Agency. If the information deviates from what is registered, this will lead to manual processing, which will cause the registration to take longer to be confirmed.
- organisation number/personal identity number
- company name
- delivery address
- email and telephone number of the company
- name, email address and telephone number of a contact person
- geographical address.
Invoicing information
- Billing address (can be the same as delivery address)
- Peppol ID or GLN and VAN for electronic invoices in Peppol or Svefaktura format.
If the company has previously received invoices from the Medical Products Agency, you must select ‘The Medical Products Agency already has the company’s invoicing information’. If the Medical Products Agency does not have the information, the invoice will be sent to the delivery address.
Number of devices
Number of devices (at the level equivalent to a UDI-ID according to the MDR) of a certain combination of category and class of device.
Information on how categories of device are stated according to EMDN can be found in the tab above.
If you have devices from one category of device but in several different risk classes, or vice versa, a number must be stated for each combination of class and type.
Examples of different combinations of type and class that must be registered separately:
|
Category |
Risk class |
|
L: Reusable surgical instruments |
MDD klass I |
|
L: Reusable surgical instruments |
MDD klass Is |
|
L: Reusable surgical instruments |
MDR klass I |
|
|
|
|
V: Medical devices – various |
MDD klass I |
|
V: Medical devices – various |
MDR klass I |
|
Q: Dental, ophtalmologic and ent devices |
MDD klass I |
|
|
|
|
W: In vitro diagnostic devices |
IVDD generell |
|
W: In vitro diagnostic devices |
IVDD självtest |
|
W: In vitro diagnostic devices |
IVDD lista A |
|
W: In vitro diagnostic devices |
IVDR klass B |
The manufacturer that the operator represents
- Name
- country
- email address
- mandate, in PDF format, that proves that your business is an authorised representative for the manufacturer.
Person responsible for regulatory compliance
- Name
- email address
NB! This does not need to be completed in the case of the manufacture and placing on the market of devices according to the MDD/AIMDD/IVDD; you can then continue without filling in the information.
Transfer to MDR/IVDR
If you register devices according to the MDD/AIMDD/IVDD, and the manufacturer for which you are an authorised representative then starts to manufacturer and place devices on the market according to the MDR/IVDR, you will need to remember to:
- change the categories and classes of the devices — classes differ between directives and regulations
- register a person responsible for regulatory compliance.
Possible amendments
- All information on the company, invoicing information and information on the person responsible for regulatory compliance may be changed or added.
- Information on the number of devices of a certain combination of device category and risk class and information on the manufacturer(s) you represent (including the mandate PDF document) may be changed, added or removed. If the number is changed, please state the updated total number.
Link to e-service
Choose the operator role ‘Authorised representative for a manufacturer of CE marked devices’ in the e-service.
Person responsible for systems and procedure packs
Please note that the e-service is adapted both to the directive-based legislation and to the EU’s MDR/IVDR regulations.
As a person responsible for systems and procedure packs, you must prepare the following information.
Information on the company
Organisation number and company name must be stated exactly as they are registered with the Swedish Companies Registration Office/Swedish Tax Agency. If the information deviates from what is registered, this will lead to manual processing, which will cause the registration to take longer to be confirmed.
- organisation number/personal identity number
- company name
- delivery address
- email and telephone number of the company
- name, email address and telephone number of a contact person
- geographical address.
Invoicing information
- Billing address (can be the same as delivery address)
- Peppol ID or GLN and VAN for electronic invoices in Peppol or Svefaktura format.
If the company has previously received invoices from the Medical Products Agency, you must select ‘The Medical Products Agency already has the company’s invoicing information’. If the Medical Products Agency does not have the information, the invoice will be sent to the delivery address.
Number of systems or procedure packs
Number of systems or procedure packs (at the level equivalent to a UDI-ID according to the MDR) of a certain combination of category and class of device.
Information on how categories of device are stated according to EMDN can be found in the tab above.
- For systems, the class is stated as the highest risk class included in the system.
- In the event of doubt of which risk class is the highest among the devices in the system (for example when the system includes devices from different regulatory frameworks for medical devices, e.g. both the MDR and IVDR), as a producer you must make your own assessment of which of the included devices constitutes the highest risk, and choose that device’s risk class as the system’s risk class.
- If you have devices from one category of device but in several different risk classes, or vice versa, a number must be stated for each combination of class and type.
Examples of different combinations of type and class that must be registered separately:
|
Category |
Risk class |
|
L: Reusable surgical instruments |
MDD klass I |
|
L: Reusable surgical instruments |
MDD klass Is |
|
L: Reusable surgical instruments |
MDR klass I |
|
|
|
|
V: Medical devices – various |
MDD klass I |
|
V: Medical devices – various |
MDR klass I |
|
Q: Dental, ophtalmologic and ent devices |
MDD klass I |
Voluntary field in the e-service
In the e-service, there is a field where you can fill in the name of the person responsible for regulatory compliance.
This is voluntary information for systems and procedure packs.
Transfer to MDR/IVDR
If you register systems and procedure packs according to the MDD and then start to manufacture and place devices on the market according to the MDR, you must remember to:
- change the categories and classes of the devices — classes differ between directives and regulations.
Possible amendments
- All information on the company, invoicing information and information on the person responsible for regulatory compliance may be changed or added.
- Information on the number of systems or procedure packs of a certain combination of device category and risk class may be changed, added or removed. If the number is changed, please state the updated total number.
Link to e-service
Choose the operator role ‘Person responsible for systems and procedure packs’ in the e-service.
Manufacturer of custom-made devices
As a manufacturer of custom-made devices, you will need to prepare the following information.
Information on the company
Organisation number and company name must be stated exactly as they are registered with the Swedish Companies Registration Office/Swedish Tax Agency. If the information deviates from what is registered, this will lead to manual processing, which will cause the registration to take longer to be confirmed.
If you belong to a region or municipality, see the information on coordinating registration above.
- organisation number/personal identity number
- company name
- delivery address
- email and telephone number of the company
- name, email address and telephone number of a contact person
- geographical address
Information on the person responsible for regulatory compliance
- name and email address
NB! This does not need to be stated for devices that are released according to the MDD
Invoicing information
- Invoicing address (can be the same as delivery address)
- Peppol ID or GLN and VAN for electronic invoices in Peppol or Svefaktura format.
If the company has previously received invoices from the Medical Products Agency, you must select ‘The Medical Products Agency already has the company’s invoicing information’.
If the Medical Products Agency does not have the information, the invoice will be sent to the delivery address.
Information on fields in which the manufacture of custom-made devices takes place
- One or more of the fields:
- disability aids
- implantable devices (non-dental)
- orthopaedic aids and prosthetics
- dental technology including dental implants
- other.
If you select ‘implantable devices (non-dental)’ as a field, you will have to answer the question ‘Are products in risk class III handled?’. This question only applies to manufacturing according to the MDR. If you release products according to the MDR, you must answer ‘No’ to the question. If you answer ‘Yes’ to the question, you will need to upload the certificate as below.
Certificate from a notified body
If you manufacture and release custom-made implantable devices in class III according to the MDR, you must have a certificate from a notified body. This must be uploaded in conjunction with the registration of the manufacturing. You will need the following information for registration:
- the four-digit identification number and name of the notified body
- certificate number
- the certificate’s expiry date
- the certificate in PDF format.
Transfer to MDR/IVDR
If you are to continue manufacturing custom-made devices after 26 May 2021, this must take place in accordance with the MDR and, if applicable, the registration must be supplemented with information on a person who is responsible for regulatory compliance.
Possible amendments
- All information on the company, invoicing information and information on the person responsible for regulatory compliance may be changed or added.
- Information on the fields where manufacturing is performed may be changed. Please enter all concerned fields, even those previously registered, in a change request.
- The information whether implantable devices in class III products are handled may be changed.
- Certificates of conformity from a notified body for implantable devices in class III may be added.
Link to e-service
Choose the operator role ‘Manufacturer of custom-made devices’ in the e-service.
Manufacturer of national medical information systems (NMI)
As a manufacturer of national medical information systems (NMI), you must prepare the following information.
Information on the company
Organisation number and company name must be stated exactly as they are registered with the Swedish Companies Registration Office/Swedish Tax Agency. If the information deviates from what is registered, this will lead to manual processing, which will cause the registration to take longer to be confirmed.
- organisation number/personal identity number
- company name
- delivery address
- email and telephone number of the company
- name, email address and telephone number of a contact person
- geographical address
Information on the person responsible for regulatory compliance
- name and email address
This is voluntary information for manufacturers of national medical information systems (NMI).
Invoicing information
- Billing address (can be the same as delivery address)
- Peppol ID or GLN and VAN for electronic invoices in Peppol or Svefaktura format.
If the company has previously received invoices from the Medical Products Agency, you must select ‘The Medical Products Agency already has the company’s invoicing information’. If the Medical Products Agency does not have the information, the invoice will be sent to the delivery address.
Information on NMI products
- product name
- software version
- EMDN code (see tab above) or a short description of the products
Possible amendments
- All information on the company, invoicing information and information on the person responsible for regulatory compliance may be changed or added.
- Information on the NMI products may be changed, added or removed.
Link to e-service
Choose the operator role ‘Manufacturer of national medical information systems (NMI)’ in the e-service.
Distributor/importer responsible for relabelling/translation or repackaging
As a distributor/importer responsible for relabelling/translation or repackaging, according to article 16.2-16.4 in the MDR, you must prepare the following information. For amendments, you only need to prepare the amended information.
Information on the company
Organisation number and company name must be stated exactly as they are registered with the Swedish Companies Registration Office/Swedish Tax Agency. If the information deviates from what is registered, this will lead to manual processing, which will cause the registration to take longer to be confirmed.
- organisation number/personal identity number
- company name
- delivery address
- email and telephone number of the company
- name, email address and telephone number of a contact person
- geographical address
Information on the person responsible for regulatory compliance
- name and email address
This is voluntary information for distributors/importers responsible för relabelling/translation or repackaging.
Information on the devices that are handled with relabelling/translation or repackaging
Mandatory information:
- device name
- legal manufacturer, or authorized representative, of the device
Voluntary information:
- device category according to the EMDN
- UDI-DI of the device
- VAT-nummer of the legal manufacturer or the authorized representative
Certificate issued by a notified body
As a distributor/importer responsible för relabelling/translation or repackaging, according to article 16.2-16.4 in the MDR, you must have a certificate issued by a notified body from the assessment of the quality management system. At least one certificate shall be uploaded when you register. You need to the following information:
- the four-digit identification code and the name of the notified body
- the identification code of the certificate
- the validity date of the certificate
- the certificate in PDF format.
Possible amendments
All information on the company, invoicing information and information on the person responsible for regulatory compliance may be changed or added.
- Information on the devices that are handled with relabelling/translation or repackaging may be changed, added or removed.
- Certificate(s) issued by a notified body from the assessment of the quality management system may be added.
Link to e-service
Choose the appropriate operator role from ’Distributor/importer responsible for relabelling/translation according to article 16’ and ’Distributor/importer responsible for rr repackaging or repackaging’ in the e-service.
Deregistration
Deregistration of an operator role is made when you completely stop the activities within that role. Please note that deregistration of single device categories, fields of devices or NMI:s is made as an amendment as described above. Deregistration needs to be completed for one role at a time. Hence, you may need to use the e-service more than once if you have registered more than one operator role with the Swedish Medical Products Agency.
All data field in the e-service need to be completed. The information that needs to be submitted is:
- organisation number/personal identity number
- company name as registered with Swedish Companies Registration Office – NB! Be careful to state it exactly as registered, including “AB” and such suffixes.
- the operator role to be deregistered – NB! You can only deregister one (1) role at a time in the e-service
- name and email address of the person submitting the deregistration request
When the handling of the deregistration request have been completed, a confirmation of the deregistration will be sent to all email addresses that have been registered for the concerned operator role.
Registration in EUDAMED
Registration when EUDAMED is fully functional
Operators that shall be registered in EUDAMED
- manufacturers of CE marked devices and accessories
- authorised representatives (AR) for manufacturers of CE marked devices and accessories
- importers
Manufacturers and AR:s established in Sweden shall only be registered with the MPA until EUDAMED is fully functional. Importers shall not be registered with the MPA, they shall register in EUDAMED.
When EUDAMED is fully functional, the aforementioned operators and their devices/accessories shall be registered in EUDAMED. There will be transitional provisions for registration in EUDAMED.
Operators that shall not be registered in EUDAMED
- manufacturers of custom-made devices
- manufacturers of national medical information systems (NMI)
- distributors and importers responsible for relabelling/translation or repackaging according to the provisions in article 16.2-16.4 in MDR
These operators shall be registered with the MPA also when EUDAMED is fully functional.
Voluntary registration in EUDAMED
The operators that shall be registrered in EUDAMED (manufacturer, AR, importer) may already register to obtain a single registration number (SRN). Such registration is voluntary until EUDAMED is fully functional.
Further modules of EUDAMED will be made available in due course.
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Contact us
Department of Medical devices
Telephone: +46 (0)18-17 46 00
Email: registrator@lakemedelsverket.se