Medical devices incorporating a medicinal substance

Request to initiate a new initial consultation application

The Notified body will complete a request form and submit to the Medical Products Agency by email for all new initial consultations, MDR-reassessments and transfers. If a pre-submission meeting or a teleconference is requested, this should be specified in the form together with issues for discussion. The notified body is expected to take part in the presubmission meeting.

The MPA will respond by e‍-‍mail whether the request can be accepted (based on the availability of required expertise). The response will include:

• information when the MPA is prepared to receive the documentation
• estimated assessment time
• classification of the application
• fee
• information about meeting arrangements, if applicable.

The timetable is valid provided the documentation is submitted according to the agreed date. In case of delay, a revised timetable should be discussed with the MPA.

Request form for consultation

The form should be sent by email to registrator@lakemedelsverket.se

Application for consultation - the process

To start the consultation procedure an Application form should be completed and scientific documentation attached. The application including documentation, preferably as electronic‍-‍only submission, should be sent via CESP (Common European Submission Portal) or Eudralink alternatively by email to RIC@lakemedelsverket.se. Using the Non-eCTD electronic Submission (NeeS) format is strongly recommended, where the documentation is submitted in smaller files divided in folders following the Common Technical Document (CTD) structure which is used for medicinal product Marketing Authorisation applications. Presentation of the data in line with CTD principles will facilitate an efficient review by the MPA. A NeeS guidance document can be found on the eSubmission website, though bear in mind not all topics therein are relevant to these submissions, e.g. technical validation. All study reports/literature references (full text) should be included in the documentation.

Application form for initial consultation, reassessment or transfer

Application form for variation/supplementary consultation

After registration of the application, a coordinator for the consultation procedure will be appointed by the MPA. A new reference number will be assigned and communicated to the Notified Body. In subsequent correspondence concerning the consultation process, this reference number should be specified.

A 210‍-‍day procedure is normally applied for new applications and the assessment report with opinion will be sent to the Notified Body. The estimated time to primary assessment is 110 days for new applications. In case of concerns, a request for supplementary information or clarification will be sent as part of the assessment report to the Notified Body. 

The Notified Body will, shortly after registration of the application for consultation, receive an invoice specifying the fee in accordance with the information in the table below.

Fees

The Swedish government decides the fees for medical devices in Sweden and introduces them into national legislation.

Supplementary consultations

Before any change is made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the manufacturer shall inform the notified body of the changes. That notified body shall seek the opinion of the medicinal products authority consulted, in order to confirm that the quality and safety of the ancillary substance remain unchanged. This opinion is called a supplementary consultation or application for variation. Supplementary consultations are classified as major or minor by analogy to the variations regulation for medicinal products (Commission Regulation (EC) 1234/2008). If the MPA was the initially consulted competent authority a request for consultation form does not need to be submitted before a variation application is submitted. For both major and minor variations a 60-day timeline with 40 days to primary assessment applies.

Guidance with example of changes

The example below is related to changes and consultations previously evaluated by the MPA. Examples not requiring consultation are also specified.

Examples of changes classified as major and where a supplementary consultation should be requested

• Change of the drug release profile of the coated coronary stent, resulting in a change of the accepted specification limits for drug release.
• New manufacturer of the drug substance, i.e. change or addition of a drug substance manufacturer.

Examples of changes classified as minor and where a supplementary consultation should be requested

• Extension of shelf life of the stent
• Reduced sample size for specification testing.
• Minor change in specification parameter, for example, reduced testing frequency.
• Test method optimization.

Examples of changes generally not requiring a supplementary consultation or a notification

• Extension of shelf life for a new strength of the stent up to the shelf life of the already assessed/approved strengths. changes to the developmental section, change in characterization tests (note: not to mix up with specification test).
• Changes concerning the excipients relating to e.g. change of or addition of vendor, tightened specification limits, test method modification/optimization, inclusion of alternate storage conditions or extension of a retest period.
• Changes of the manufacturing process of the coated stent which do not affect the quality of the drug substance.
• Changes in the drug substance specification in order to be in compliance with the current specification for the substance (from the same manufacturer) that is used in a medicinal product on the EU market. (It is assumed that the manufacturer of the medical device applies the same approved drug substance specification as the manufacturer of the medicinal product).

MDR-reassessment for products subject to previous consultation under MDD

In April 2017 new EU regulation on medical devices was adopted, Regulation (EU) 2017/745 on Medical Devices (MDR). It entered into force in May 2017 and the transitional period ends in May 2021. The previous legislation was council Directive 93/42/EEC (Medical Devices Directive, MDD).

In order for the notified body to issue the first certificate for a given device under the MDR, a full conformity assessment covering all requirements has to be carried out even if the device has been certified under the MDD. For devices containing ancillary substances, this includes the consultation of the medicinal products authority as per Article 52 (9) of the MDR. In order for such a device to be certified, a medicinal products authority needs to be consulted again for an opinion of the ancillary substance under MDR prior to certification as per MDCG 2020‍-‍12. This opinion is at the MPA called an MDR-reassessment.

Reassessment procedure 

To consult the MPA on a device which has previously undergone a consultation for ancillary substances under MDD at the MPA now to be certified under MDR, submit a request form to registrator@lakemedelsverket.se. In case the consultation under MDD was performed by another National Competent Authority than the MPA, please state in the form that it is both a transfer and an MDR‍-‍reassessment that is requested.

After the MPA has accepted the request for reassessment the full documentation package should be submitted including the previous opinion of the competent authority under the MDD/AIMDD (initial and/or supplementary), as well as for each device a consolidated list of changes, if any, including the judgement of the notified body of if the changes may have an impact on previous consultations assessed by the authority in the following:

• the ancillary substance,
• its manufacturing process,
• the way the substance is incorporated into the device,
• design, manufacturing of the device which could influence the quality, safety or usefulness of the ancillary substance, and/or
• the parts of the technical documentation related to the above aspects.

If there were no changes to some or any of the above, the package may be accompanied by a declaration by the notified body to this effect, stating the elements that have remained identical. If there have also been no changes to the assessment of this documentation by the notified body, this may be included in the declaration. Should there be only administrative changes to the above (e.g. changes of names or addresses, changes in document layout, etc.), these should be clearly detailed in the declaration. Please submit with the documentation an application form for a new consultation and state that it concerns an MDR‍-‍reassessment.

The MPA will review the application and issue its opinion in 210 days at the latest. The depth of the review will depend on how recent the previous consultation was and the extent of the changes since the previous consultation. This will also affect the time required for the assessment.

We recommend that the request is submitted 3 months before planned start date of the consultation. Since the reassessment can take up to 210 days (excluding clockstop) we recommend to plan the start date at least 9 months before the certificate expires.

Fee for reassessment

The fee for an MDR‍-‍reassessment is 150 000 SEK as it is seen as an opinion on a known active substance in an established therapeutic area by the MPA. Products within the same product family (i.e. same ancillary medicinal substance and manufacturing) can be consulted on together, unless there are significant differences between the products.

It is possible to request a reduction of the fee for products where the MPA (and not another competent authority) was consulted under MDD, or if a certificate stating that the product is identical to the product previously assessed under MDD is included.

The request for reduction of the fee should be stated in the application form and included when the documentation package is submitted.

Transfer from the current NCA to MPA

To request a change of national competent authority a please submit the request for consultation form (see above) to the MPA to registrator@lakemedelsverket.se. If a transfer is requested for a product certified under MDD and not under MDR, it is recommended to also initiate the MDR consultation process at the same time. In that case, please state in the form that an MDR-reassessment is also requested. The transfer and MDR‍-‍reassessment will be handled in parallel.

If the MPA accepts the transfer, the full documentation assessed by the previous NCA should be submitted. All reports from the previous NCA should also be enclosed. The transfer itself is an administrative process that does not result in a new scientific opinion by the MPA.

Webinar

Below you will find the recording and presentation from the webinar on consultation procedures for medical devices with an ancillary substance that took place in November 2024.

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