MDCG Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.
Article 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as amended by Regulation (EU) 2022/1121 , states that under certain conditions the following devices may be placed on the market or put into service after the date of application of the IVDR, i.e. 26 May 2022, until the end of the different transition periods specified in Article 110(3) IVDR:
- Devices which have a valid certificate issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), and
- Devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified body.
In line with Q&A 9 of the CAMD’s FAQ – IVDR Transitional provisions, the certificates covered by Article 110(3) of the IVDR include all certificates which are commonly issued by notified bodies3 with reference to the IVDD.
The conditions for the application of the transitional provisions in Article 110(3) IVDR are that the
- devices continue to comply with the IVDD
- and that there are no significant changes in the design or intended purpose of the device after the date of application of the IVDR.
Therefore, it is important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’ under Article 110(3) IVDR.
To the extent that devices subject to the transitional provisions in Article 110(3) IVDR are covered by certificates issued by a notified body in accordance with the IVDD, it is essential for IVDs to be placed on the market that those certificates remain valid following changes that are not significant with regard to design or intended purpose and that the required appropriate surveillance is carried out by the notified body that issued the certificate. Manufacturer and respective notified body should agree on the latter on a contractual basis.
This guidance document is based on MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. Where appropriate, this guidance document is adapted to the IVD sector and it takes into account experience gained with the application of MDCG 2020-3.
It is important to highlight that no issuing of new IVDD certificates is allowed under IVDR Article 110(3). In particular, if the manufacturer wishes to make a ‘significant change in design or intended purpose’ within the meaning of IVDR Article 110(3), the implementation of such a change would prevent the manufacturer from placing the device on the market under the IVDD in accordance with that provision.
In order to benefit from the transition periods provided in Article 110(3) IVDR, devices may not undergo any significant change in the design or intended purpose after the date of application of the IVDR, i.e. 26 May 2022.
This condition consists of two elements:
- there is a change in the design or intended purpose and
- that change is non-significant. That means that changes that do not concern the design or intended purpose are out of scope of Article 110(3) IVDR. Equally, changes that concern the design or intended purpose only fall under Article 110(3) IVDR if they are considered ‘significant’.
The manufacturer always remains responsible for providing evidence that changes neither affect the design nor the intended purpose. When a change is likely to affect the design or the intended purpose of the device, the significance of such a change should be assessed case-by-case providing evidence for the outcome of the assessment. The manufacturer must be able to justify their decision when the changes are considered to be non-significant. The justification shall be documented and made available to a competent authority when requested.
If a change is not a significant change in design or intended purpose under IVDR Article 110(3), the implementation of such a change is allowed during the transitional period without the need for certification under the IVDR. In such cases, the manufacturer needs to comply with the documentation requirements of the IVDD, i.e. the updated technical documentation must allow assessment of the conformity of the product with the applicable requirements.
Additional considerations for devices covered by a certificate issued by a notified body
In line with the agreed arrangements for notification of changes between the manufacturer and the notified body according to the IVDD (e.g. contractual relationships, approved procedures), changes and their implementation will be verified by the notified body as part of the surveillance activities, or following a manufacturer’s submission for prior approval. The outcome of this verification will determine whether a certificate in accordance with the IVDD remains valid according to Article 110 IVDR. In case of doubt as to whether a given change is significant, manufacturers should ask their notified body.
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The certificate should not be amended. However, the notified body that issued the certificate in accordance with the IVDD may confirm in writing, after having reviewed the manufacturer’s description of the (proposed) change, that the implementation of the change does not represent a significant change in design or intended purpose under IVDR Article 110(3) and that the related IVDD certificate remains valid after the date of application of the IVDR, but no longer than its expiry date or 26 May 2025, whichever comes first.
Such written confirmation corrects or complements information on an existing certificate but does not represent the issuance of a ‘supplemented certificate’, since this is prohibited as mentioned in Section 3 of the publication. In case of requests from authorities, the manufacturer should number such letters received from the notified body and submit them together with the certificate.
Where the conformity assessment procedure under the IVDD requires the quality management system (QMS) to be approved by a notified body, the manufacturer must observe that the conditions for which the certificate was granted are maintained. In any case, changes to the QMS continue to be subject to the agreed notification procedure between manufacturer and notified body.
Changes not concerning the design or intended purpose:
Changes concerning the manufacturer’s organisation (administrative changes) or changes concerning the manufacturing process should generally not be considered changes in the design or intended purpose within the meaning of Article 110(3) IVDR, even if they need to be reflected in the information to be supplied with the device (e.g. label or instructions for use).
This includes for example:
- changes of the manufacturer’s name, address or legal form, including a merger or acquisition involving the manufacturer;
- changes in relation to the authorised representative;
- relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers;
- changing the supplier of a material, ingredient or component, provided the specifications of the new material, ingredient or component do not change;
- adding or replacing a new material number for logistic reasons without changing the material;
- changes to outer packaging (e.g. size, material, layout) that do not adversely affect the stability, sterility or microbiological state of the device;
- new process validation as part of manufacturing improvements or scale-up of manufacturing.
Changes of the QMS, such as changes in the monitoring and control of production and operations environment, generally do not impact the design or intended purpose either, provided that the conditions for which the conformity assessment certification was granted are maintained.
Changes in the design or intended purpose:
As the devices that are placed on the market in accordance with the transitional provision laid down in Article 110(3) IVDR need to be in compliance with Directive 98/79/EC, the benchmark for determining their design and intended purpose, as well as any possible change, should be the IVDD.
While the IVDD does not define the ‘design’ of a device, the ‘intended purpose’ means “the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials” (Article 1(2), point (h), of the IVDD).
Not all changes concerning the design or intended purpose would automatically have to be regarded as ‘significant’. Whether or not a change is significant has to be assessed case by case.
These charts serve as a guide for understanding the significant change!
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