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FAQ – Medical Devices

Yes. A preliminary evaluation of the juridical framework of a product, usually a “feasibility study”, is a very strategic procedure that is more and more preferred by companies that want to understand in time whether a product under development can be classified as a medical device and if so, in which risk class.

The performance of a study of this kind, in the suitable time, allows companies to forecast and plan resources, costs and time required to get to the market, and prevents unnecessary or unforeseenable losses and delays.

No, all medical devices of all risk classes should be accompanied by appropriate technical documentation that should always be prepared before putting the device on the market.

The fact that a Notified Body is either used or not does not affect the obligation of the manufacturer to have technical documentation available.

Once the medical device is registered by the manufacturer and put on the market, and the device is therefore CE-marked, the manufacturer becomes subject to vigilance and surveillance activities by the Competent Authorities of the Member States where the device is marketed.

Consequently, the manufacturer can be requested to show the technical documentation at any time.

The technical dossier is defined based on the conformity procedure that the manufacturer may choose according to the class of the medical device. The content of a technical dossier is established in the annexes of Regulation 2017/745 EU (annexes II and III).

The following can be highlighted among some common and transversal points: the solutions adopted for the conformity with the essential requirements (established in Annex I), the device risk analysis, the device non-clinical and clinical assessment.

Yes. Each extra-EU manufacturer has the obligation to establish one and only one authorised representative, at least for all variants of a same model.

However, if an extra-EU manufacturer put on the EU market different models of medical devices, they can establish more than one authorised representative, each for one and only one model of medical device.

In conclusion, there is an exclusive relation between an authorised representative and a medical device but not between an authorised representative and a manufacturer.

The Italian competent authority for MDs and IVDs is the Ministry of Health. The High Health Institute (Istituto Superiore di Sanità, ISS), although operating also in the field of medical devices, is not the competent authority and plays the role of Notified Body.

A FSC is a document certifying the CE-marking of a medical device intended for exportation to extra-EU countries.

A FSC can be only applied by manufacturers with legal office in Italy and by authorised representatives with legal office in Italy.

A clinical evaluation is a document including and examining the whole set of clinical data on a medical device and on equivalent devices as well as all information on the state of the art in the specific sector where a medical device is used.

It is aimed at evaluating the risk/benefit profile from the clinical point of view of the use of a medical device, and is therefore related to the risk analysis.

It is also aimed at demonstrating that the pertinent essential requirements are met.

The clinical evaluation starts from the performance of a preliminarily planned process and is achieved by drafting a report; it should be updated either periodically or as soon as new information is known that can affect the conclusions of the evaluation itself; it gathers all information coming from the vigilance and surveillance activities; it examines critically the pertinent medical scientific literature and should assess, when present, the clinical investigations carried out with a medical device.

Yes, advertising of devices to the public is subject to the authorisation of the Ministry of Health.

PRRN is an acronym that stands for “person responsible for regulatory compliance”.

This is a professional figure that manufacturers and authorised representatives of medical devices should mandatorily have at their disposal according to Regulation 2017/745 EU.

The PRRN minimum requirements and responsibilities are described in article 15 of the MDR; the guideline MDCG 2019-7 can also be referred to for further regulatory indications.