MDCG publishes IVDR surveillance guidelines MDCG 2022-6, regarding the transitional provision under Article 110(3) of the IVDR – published at cemarking.net – May 5, 2022
To Whom it Applies
The aim of this guidance document is to provide clarification on the concept of “significant changes in the design and intended purpose” under IVDR Article 110(3). It applies to producers of devices that comply with Directive 98/79/EC. Furthermore, they are placed on the market or put into operation after May 26, 2022, during the transition period. It must also be in accordance with Article 110(3) IVDR, regardless of whether those devices required notified body involvement under the IVDD at the time.
To Whom it Does Not Apply
The process for manufacturers submitting and notified bodies assessing changes to the approved design or substantial changes to the approved quality system or the line of products covered that are part of the conformity assessment process and surveillance defined by the appropriate notified body under the IVDD is not covered in this guidance document.
What is Included?
- The determination of whether alterations are “substantial changes in the design or intended purpose” in accordance with IVDR Article110(3).
- Changes not concerning the design or the intended purpose
- Changes that do concern the design or the intended purpose
- CHART A – Changes in the intended purpose
- CHART B – Changes in the design
- CHART C – Changes in the software
- CHART D – Changes related to an ingredient or material
- CHART E – Changes in the design
The Assessment of Changes
Devices should not undergo any major changes in design or intended purpose after the date of application of the IVDR (that is 26 May 2022), in order to benefit from the transition periods established in Article 110(3) IVDR. This condition consists of two elements:
- there is a change in the design or intended purpose and
- that change is non-significant.
Article 110(3) IVDR does not apply to adjustments that do not affect the design or intended function of the product. Changes to the design or intended purpose, on the other hand, are only covered under Article 110(3) IVDR if they are considered “substantial.” The manufacturer is always responsible for demonstrating that adjustments do not have an impact on the design or the intended purpose. When a modification is likely to influence the device’s design or intended purpose. Furthermore, the relevance of the change should be evaluated on a case-by-case basis. Also, this must be accompanied by evidence to support the assessment’s conclusion. When the changes are considered insignificant, the maker must be able to justify their decision. Importantly, when a competent authority requests it, the justification must be documented and made available.
Moreover, there are additional considerations for devices covered by a certificate issued by a notified body. These are further explained in the document as you can find in the link below this article.
Changes Not Concerning the Design or Intended Purpose
Even if they have to be incorporated in the information to be supplied with the device, changes in the manufacturer’s organization (administrative changes) or changes in the manufacturing process should not be considered changes in the design or intended purpose within the scope of Article 110(3) IVDR (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 authorized 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 in the QMS have little effect on the design or intended purpose, as long as the conditions for which the conformity assessment certification was issued are met.
Changes That do Concern the Design or the Intended Purpose
This paragraph in the guidelines addresses several subjects. First of all, it addresses the design and the intended purpose. Secondly, it explains the significance of changes. Thirdly, it clarifies some general considerations. These are further described in the document as you can find in the link below this article.
MDCG 2022-6 Annex and Chart A:
MDCG 2022-6 Chart B and Chart C:
MDCG 2022-6 Chart D and Chart E:
To analyze the flowcharts we kindly refer to the guidance document MDCG 2022-6 as listed below this article.
MDCG publishes IVDR Surveillance Guidelines – MDCG 2022-6: Sources, Links and Downloads
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