MDCG publishes two guidances for products without intended medical purpose

The European Commission’s Medical Device Coordination Group (MDCG) has published two guidances on how manufacturers of products without an intended medical purpose can conform to the Medical Device Regulation (MDR).

On 14 December, MDCG published the documents that outline how products such as colored contact lenses, brain stimulation devices and certain plastic surgery products listed in Annex XVI of the MDR can conform to the regulation. Specifically, the guidances detail how such products an conform to the Commission Implementing Regulation (EU) 2022/23463, also known as the common specifications (CS).

The MDCG 2023-5 guidance lays out how products without an intended medical purpose can meet the qualification and classification requirements under MDR. The document provides explanations and examples that detail the groups thinking on the matter for manufacturers submitting applications to meet the conformity assessment requirements in the regulation.

“The examples provided do not imply that the products are a priori qualified as devices,” said MDCG.

“Classification rules apply after the qualification of the product as a device has been established,” the group added. “This guidance document should be used in conjunction with the MDCG 2021-24 on classification of medical devices and take into consideration Commission Implementing Regulation (EU) 2022/2347 on reclassification.”

The guidance states that the qualification of a device should be based on information in Annex XVI and in the scope sections of the CS. It notes those qualifications include details such as the type of product, the functioning modalities and the intended body part that is being addressed by the product. It also notes that the regulation requires that the products need to be similar to analogues medical devices in terms of how they function and their risk profile.

“This guiding principle is reflected in Article 1(2) of the MDR to take into account the state of the art, and in particular existing harmonized standards for analogous devices with a medical purpose, based on similar technology,” the guidance states. “Similarities with analogous medical devices can therefore also be considered as a guiding principle for the qualification of the product as a device.”

While accessories for products without an intended medical purpose are not defined in Article 2 of the MDR, the guidance states that they do fall within the regulation if they meet the description in Annex XVI and fall under the definition of a regulated product in the CS. Furthermore, if the accessory can be used in combination with the product it can be allowed on the market as a piece of the product, but if it can be used on its own, it can be considered a stand-alone product.

The second guidance, MDCG 2023-6, addresses how to demonstrate a product without an intended medical purpose is equivalent to a product already on the market based on relevant data.

“Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety and performance of devices for the purpose of CE marking, clinical data can also be sourced from data of a device for which the equivalence to the device in question can be demonstrated,” the guidance states. “In such cases, equivalence shall be demonstrated according to the MDR requirements.”

When demonstrating equivalence, the guidance breaks down the product categories into three types. In the first category, when a product without an intended medical purpose is compared to another product on the market without an intended medical purpose, the clinical data should demonstrate the equivalency of the products based on the technical, biological and clinical characteristics.

“The technical and biological criteria listed in the MDR can be directly considered to compare characteristics of products without an intended medical purpose,” the guidance states. “The criterion for the clinical characteristics should be considered taking into account that some of them are specifically referring to a medical purpose.”

In the second category where products without an intended medical purpose are compared to those that are analogous medical devices, MDCG says a comparison is not possible because not all the clinical characteristics can be compared.

“In particular, the characteristic ‘similar severity and stage of disease’ would be defined and available for the medical device while it would not be defined and available for the product without an intended medical purpose,” the guidance states. “As a consequence, the demonstration of equivalence cannot be completed and established between a device without an intended medical purpose and an analogous device with a medical purpose.”

In the final category, MDCG says equivalency between a product without an intended medical purpose and a device with both a medical and a non-medical purpose can be demonstrated but must be based on the characteristics of the non-medical purpose of both devices. RAPS.org