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Custom-made medical devices and Regulation 2017/745

What are custom-made medical devices? A custom-made medical device is defined as follows:

any device specifically made in accordance with a written prescription […] which gives […] specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs”.

This definition has remained almost unvaried in the shift from the Directive to Regulation (EU) 2017/745, however the latter – whose complete implementation took place in May 2021 – has added a series of requirements for manufacturers involving either directly or indirectly all figures taking part in the supply chain.

Several commonly used products are categorised as custom-made devices, such as dentures, plantars, and also some types of eyeglasses and hearing aids. These are characterised by a design that is not standardised such as for other medical devices on the market.

According to annex XIII of Reg. (EU) 2017/745 manufacturers of medical devices have the obligation to draft a declaration of conformity stating the conformity of the products with the legal provisions.

How are custom-made devices classified?

Custom-made medical devices are not CE-marked, and have specific conformity assessment procedures. Contrary to what you could think, they also follow the classification as per article 51 of Regulation (UE) 2017/745, and are thefore divided into class I, IIa, IIb and III  based on their intended use and involved risks.

The obligations of custon-made MD manufacturers

The novelties brought by the Regulation regard in particular traceability and post-market surveillance system.

Orthopaedists, opticians, prosthodontists are only some of the figures affected by regulatory changes. The Regulation has in fact added a series of requirements that involve them more in the whole post-market surveillance system that is integral part of the quality management system.

In the post-market phase, custom-made device manufacturers should cooperate with the competent authorities (when necessary), complying with all their responsibilities on vigilance and correction.

Not only; in the specific case of class III implantable custom-made devices, notified bodies intervene on the very control of the quality system (Art. 52 of the Regulation) that the manufacturer has the obligation to set up.

Clinical Evaluation Process

The Regulation provided for that all medical devices are subject to a clinical evaluation process, including custom-made devices.

The device evaluation process should, on one hand, include sufficient clinical data to ensure the device safety and performance, on the other be part of a specific performance post-evaluation program, including the collection of information on similar devices.

Therefore, a risk/benefit profile analysis as well as drafting a technical dossier  relying on a clinical evaluation is also required for custom-made devices to be able to release a declaration as per Annex XIII.

According to the Regulation, the manufacturer should also store the documentation regarding the device for a period of at least 10 years, 15 in case of implantable MDs (the Directive provided for 5 years) from the date of marketing.

Such documentation must be available for authorities and should include a

Series of essential information such as the design, manufacturing place, and surveillance plan.

It is clear that Regulation EU 2017/745 has defined a series of issues involving several professional figures, making them active part in the whole post-market surveillance process, required not only to ensure the conformity of their own custom-made devices, but also to maintain such conformity to the regulations for the whole life-cycle of the device itself.

The new Italian registration system for custom-made medical devices

MD manufacturers and authorised representatives with a legal office in Italy have the obligation to register into the list of the Ministry of Health and to transmit the data on their marketed custom-made devices.

Such registration has the goal of collecting information, ensuring an effective control by the Ministry of Health on the sector of custom-made medical devices.

The Decree of the Ministry of Health of 9 June 2023, has established the method to transmit and store manufacturers’ data and the list of custom-made medical devices available on the national territory, according to Regulation (EU) 2017/745.

As provided for by article 7 of legislative decree 5 August 2022, no. 137, that data indicated in the registration application should be updated within thirty days in case they are amended, or in case the type of manufactured devices has changed.

Moreover, in case a custom-made device manufacturer goes out of business, they have to inform the Ministry of Health within thirty days.

The Decree of 9 June 2023 provided for transient provisions for the online registration of manufacturers already registered in the lists of the Ministry of Health set up based on the Directive: initially, 6 months were granted to allow manufacturers and authorised representative to transmit their data via the online platform and obtain a new ITCA number.

On request of some trade associations, however, the Ministry of Health have informed that the deadline to comply is not 1st September 2023, but 1st May 2024. In fact, it should be considered that the online service became operative only on 25 September 2023.

As of 2nd May 2024, however, the pre-existing lists of MD manufacturers and authorised representatives with legal office in Italy will be disactivated.

Di Renzo Regulatory Affairs also support and assist custom-made medical device manufacturers, helping them to comply with legal requirements such as those introduced for the registration in the national list.

Written on 04/03/2024 by Riccardo Del Signore