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Custom-made devices and Regulation 2017/745

Article 1, section 2 of the Medical Device Directive 93/42/EEC defines as “custom-made device” any device specifically made in accordance with a (…) 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 remained almost unvaried in the shift from the Directive to Regulation 2017/745/EU, but the latter, whose implementation has been recently postponed to May 2021, adds a series of requirements from manufacturers that will directly or indirectly involved all figures taking part to the supply chain until the final user.

The above applies to several commonly used devices, such as dental prostheses, orthotics, or even some types of eyeglasses and hearing aids. These devices are not CE marked, and have their own design that is not standardised as for other medical devices on the market. The respective manufacturers, however, have the obligation to draft the product declaration of conformity to Directive 93/42/EEC. The declaration represents the actual evidence that all essential requirements were met and that, therefore, the medical device was manufactured complying with the essential criteria for the safety of patients and/or final users.

Currently, manufacturers and authorised representatives of MDs located in Italy also have the obligation to register into a dedicated list of the Ministry of Health, and to transmit the data regarding their custom-made medical devices placed on the market. This registration aims at collecting information, ensuring an effective control by the Ministry of Health on the sector of the custom-made medical devices.

The novelties introduced by the Regulation concern especially the traceability system and the post-marketing surveillance. Orthopaedists, opticians, dental technicians are some of the professional figures undergoing changes in relation to the manufacturing of their products that can be classified as custom-made devices.

If a declaration of conformity was sufficient for the Directive to acknowledge their role as manufacturers, the new Regulation adds a series of requirements involving them much more in the whole post-marketing surveillance system, that is integral part of the quality management system. In the post-marketing phase, manufacturers of custom-made devices – even though not bound to transmit any information to notified bodies – should in fact cooperate with competent authorities (when required), complying with their responsibilities on vigilance and correction. And what’s more, in the specific case of custom-made implantable devices of class III, the notified body will intervene on the quality system control (Art. 52 of the Regulation), for which manufacturers shall be prepared.

The Regulation provides for that all medical devices, including custom-made devices, undergo a clinical evaluation process. On one hand, the device evaluation process shall include sufficient clinical data to ensure the safety and performance of the device; on the other hand, it should be part of a specific retrospective evaluation program on performance, including the collection of information on similar devices.

So, for custom-made devices, characterised by definition by the absence of standardisation, it will also be necessary to identify an analysis of the risk/benefit profile in order to release a declaration of conformity based on a technical dossier also taking into account the necessary clinical evaluation. With the Regulation, the manufacturer shall also keep the documentation regarding device of a period of at least 10 years, – 15 in case of implantable devices – (the Directive currently in force provides for 5 years) from the date of its marketing. Such documentation shall be available to national authorities and shall include a series of essential information such as design, manufacturing site and surveillance plan.

Therefore, it is clear that Regulation 2017/745 will define a series of points involving different professionals, from dental technicians to opticians, making them acting parties in the whole post-marketing surveillance process, necessary not only to ensure the conformity of their custom-made devices, but also to maintain such conformity to regulations for the whole life cycle of the device itself.

Written by: Sofia Tabacco