Yes. The manufacturer of a medical devices can entrust a third party with the total or partial management of a clinical trial.
Clinical trials with medical devices that are not CE-marked or that have been changed according to their intended use, can be carried out only at health facilities indicated in the Ministry Decree 12 March 2013. Clinical trials with CE-marked medical devices used according to their intended use can instead be carried out at any public or private health facility, that is suitable for the type of device.
Yes. The sponsor is bound to have the positive opinion of the Ethics Committee locally competent for Ce-marked and non CE-marked medical devices.
The first step is backwards. The MD software is still a MD that must comply with all essential requirements applicable by law. In ordinary cases this involves the use of the harmonized norm EN 62304. This helps the manufacturer in his path to make the software starting from the design phase. For this reason, it is appropriate and advisable to use the norm before making the software and not after, when the requirements of the norm and its consequences will have already affected the timetable of the design.
The legal provision defies all software as active medical devices. Of course a software, still more if it is a stand-alone software, is an immaterial object only working inside an electronic processor, that is a material object. It’s up to the manufacturer whether to specify which are the electronic processor of third parts (including hardware, OS, etc.) by which it is possible to use their MD software.
The certification for the CE marking follows the usual conformity procedures established for the different MD classes, as well as for IVDs. The presumption of conformity to the essential requirements, ensured by the application of the harmonised norm EN 62304 both for MDs and IVDs, dose not require the standard certification, even if some bodies offer this service.
Yes, only if more FSCs are required with the same content and intended for the exportation to the same country. Otherwise, different requests are required.
The FSC can be requested only by manufacturers with legal office in Italy and by authorised representatives with legal office in Italy.
Its being compulsory depends on the exportation country, that may request this documentation.
The FSC is a document stating the CE marking of the medical device that the manufacturers intends to export to extra-EU countries.
The “nomenclatore tariffario” contains a list of healthcare procedures and devices reimbursed by the Italian National Health System in the framework of the assistance to disabled people. This has been recently updated after many years, within the new essential levels of assistance fixed by a decree of the Italian Prime Minister.
No. In the case of high-risk or highly technological medical devices, for instance, often it is not enough to carry out an assessment of the literature clinical data reporting it in the Technical Dossier, but it could be necessary to carry out a new trial.
The new Medical Device Regulation provides for the submission of more grounded clinical data to support the CE marking of the Medical Device. The requirements of the clinical assessment will be stricter and there will be the need to give evidence of the clinical benefits of the device and provide rigorous evidence of equivalence if the assessment is based on comparable devices.
It is therefore expected that the new regulation will bring an increased need of clinical trial to obtain and maintain CE markings for high-risk devices, including some class IIb devices. For lower- risk devices, instead, clinical trials shall be carried out if the clinical assessment on existing clinical data is not sufficient.
The clinical assessment is a document containing and analysing the set of clinical data on the medical device or on equivalent medical devices as well as all information on the state of the art in the specific sector where the medical device is used. This is aimed at assessing the risk/benefit profile of the use of medical device from a clinical point of view, as it is aimed at giving evidence of its meeting the pertinent essential requirements.
Clinical assessment starts from the performance of a process previously planned and it is realized in the drafting of a report document; it must be periodically updated or as soon as information is available that can affect the conclusions of the assessment itself; it collects all information from vigilance and surveillance activities; it critically analyses the pertinent medical and scientific literature and shall assess clinical investigations carried out with the medical device, if any.
For manufacturers, vigilance is the set of activities managing all processing steps regarding the (occurred or potential) incidents that have been reported or one is aware of, following the marketing of the medical device.
Surveillance is instead a set of activities for the collection and management or all information regarding the medical devices marketed and all similar or equivalent medical devices.
The manufacturer’s surveillance can also include the design, manufacturing and control of the conformity of the CE marked medical devices.
Yes, device advertising to the public is subject to an authorisation by the Ministry of Health.
No, only the devices that can be sold without prescription or which use does not need the assistance of a doctor or other health professional.
Yes, a company like Renzo Regulatory Affairs can perform and assist the Post-Marketing Surveillance activities, with the support of the manufacturer.
The manufacturer of the medical device is always responsible for this activity.
Beside being a legal obligation, Post-Marketing Surveillance (PMS) is an essential source of information that can be used for different scopes. The manufacturer has in fact other obligations, including the update of the clinical assessment, market vigilance and risk management.
By appropriate PMS the manufacturer may obtain information on the safety and performance profile of his device or similar devices on the market that can be used for the risk management plan and for the clinical assessment. Finally, the set of information from an appropriate PMS can be used in the further development of the medical device, providing a strategic advantage to the manufacturer versus the competitors.
Yes, always. It is compulsory that every manufacturer sets up a Post-Marketing Surveillance (PMS) system for each medical device and regardless its risk class. Although the PMS responsibility is always of the manufacture, he is free to consult and be supported by a provider for the definition, implementation, execution and update of the PMS.
Yes. Every extra-EU manufacturer has the obligation to appoint one single authorised representative, at least for all versions of the same model. However, if the extra-EU manufacturer markets different models of medical devices in the EU, he can appoint more than one authorised representative, each for one single model of the medical device. In conclusion, the exclusive relation is between authorised representative and medical device, and not between authorised representative and manufacturer.
Medical devices imported from extra-EU countries can be marketed in the EU provided that they are ECE-marked, that the manufacturer has appointed an authorised representative for that specific medical device residing in one of the EU countries and, finally, that the manufacturer or the authorised representative has duly registered the medical device.
No. It is not always possible to market a CE-marked medical device in a Member State. Depending on the Member State and the class of the device, national implementations of the European directive regarding the registration of medical devise present different provision. It is better that the manufacturer check in time the obligation to register into the national system provided by the Union Member States where the he intends to market the device.
Yes. A preliminary assessment of the legal framework of a product, usually a “feasibility study”, is a very strategic procedure, more and more selected by companies wishing to check in time if a product under development can be framed as a medical device and the risk class it belongs to.
The carrying out of this type of study, at the suitable time, allows companies to budget and schedule resources, costs and time required to achieve the marketing without unnecessary or predictable losses and delays
No, all medical devices of all risk classes should be accompanied by appropriate technical documentation that must always be prepared before its marketing. The employ of a Notified Body does not affect the obligation of the manufacturer to prepare a technical documentation.
Once the medical device has been registered by the manufacturer and marketed and is therefore CE-marked, the manufacturer becomes subject to vigilance and surveillance by the Competent Authorities of the Member States where the device is marketed. Consequentially, the technical documentation can be requested to the manufacturer at any time.
The technical dossier is defined based on the conformity procedure that the manufacturer can select depending on the class of the medical device. The contents of a technical dossier are established in the annexes of directive MDD 93/42/EEC as amended (annexes II to VIII, considering tailor-made devices) and can be different depending on the annex selected.
The common issues between the classes are: solutions adopted for the conformity to the essential requirements (established in annex I), the risk analysis of the device, the pre-clinical and clinical assessments of the device.
Yes, the High Health Institute (ISS), is also a Notified Body that can certify most types of medical devices.
Certainly. One should only check that the Notified Body is authorized for the assessment of the conformity of the type of medical devices the manufacturer’s device belongs to.
For class I medical devices a CE conformity declaration by the manufacturer is sufficient, without prejudice to the obligation to draft, store and update a technical dossier based on the appropriate conformity procedure (Annex VII, MDD 93/42/EEC as amended) and the obligations regarding the vigilance and surveillance activities in the marketing phase.
It is necessary to employ a Notified Body in case the CE marking is to be included on tailor-made class I, sterile class I, class IIa, IIb and III medical devices, and when the manufacturer is not sure about the classification of his device to check the appropriate classification.
A Notified Body is a Certification Body appointed by a Member State for the assessment of the conformity and the release of the CE certificate of a medical device and for the surveillance of some obligations of the manufacturer during the validity of the certificates. Also extra EU certification bodies are included based on mutual recognition agreements
The CE marking can be included independently by the manufacturer for class I devices or following the certification by a Notified Body for tailor-made class I, sterile class I, class IIa, IIb and III medical devices. In all cases the manufacturer has the obligation to draft, store and update a technical device based on the appropriate conformity procedure.
It is not always easy to establish if a software is to be considered as a medical device. Some simple cases may be of help: software developed for specific IVD applications, software analysing the data acquired from a MD to provide data for a diagnosis, software controlling the functions of a MD. A valid decisional tool is given by diagram processes of MEDDEV 2.1/6, both for MDs and for IVDs.
Criteria and methods for the registration of MDs are provided for by Decree 21 December 2009 “Modifiche e integrazioni al decreto 20 febbraio 2007 recante Nuove modalità per gli adempimenti previsti per la registrazione dei dispositivi impiantabili attivi nonché per l’iscrizione nel repertorio dei dispositivi medici” (Changes and integrations to Decree 20 February 2007 containing new methods for the compliance with the provisions on the registrations of active implantable devices as well as of the inclusion in the medical device national catalogue).