Q&A: JSB Solutions questions to Emoled
1. Regarding the clinical aspect, what are the main differences that you have found between the various states and/or between the Italian regions? “Emoled has interacted mainly with Italian structures: both between regions and within the same region, the differences are many and may concern structural aspects and competence. However, the main difference is made by the Ethics Committees, as some facilitate the sponsor in carrying out its activities and provide answers in a short time, while others are less proactive. In Tuscany, fortunately, most ethics committees are very efficient”.
2. What difficulties do you encounter in registering in foreign countries? What was the most difficult challenge? “The main difficulty in registering in foreign countries is the need to produce many documents and this can be a problem when it happens to have to realize new ones. This, however, depends very much on the Member States, and the most complex case, which has been going on for a year, is that of Taiwan: the authorities of the country, in fact, are attentive to many aspects; for labeling, for example, they want a declaration from the manufacturer that the texts supplied in the local language are the same as those approved by the ON (Notified Body). In addition, they pay great attention to the validation of software and firmware, the latter a very important aspect for Emoled”.
Our focus on the EUDAMED database
The cornerstone of the new MDR – Medical Device Regulation (EU 2017/745) is EUDAMED (European Databank for Medical Devices), the European database on medical devices, developed by the European Commission for better coordination of information and safety.
The project was created to make it possible to monitor the life cycle of each medical device, to catalogue it and to manage product non-conformities or expired documentation.
In detail, the platform will allow:
- the public to be adequately informed about devices placed on the market, their certificates issued, the economic operators concerned and clinical investigations
- single identification of devices in the internal market and facilitation of traceability
- manufacturers to fulfil information requirements
- the competent authorities of the Member States and the Commission, to carry out their activities in relation to the new Regulation
- to the public to be adequately informed about clinical investigations
- sponsors of clinical investigations ,to meet the obligations set out in the new regulation.
EUDAMED consists of six modules:
- registration of economic operators
- UDI device recording
- certified bodies
- post-market surveillance and surveillance
- clinical investigations
- market surveillance
In particular, the Electronic Catalogue (UDI Unique Device Identification), will include all medical devices on the market in Europe and will be available for consultation by all interested parties.
The database should record the UDI-DI codes, identifiers of the specific device, and the Basic UDI-DI codes, primary indicators of a family of devices that identify a group of belonging.
Despite the postponement to 2022 of the establishment of the European database with the activation of all modules EUDAMED, from 26 May 2021, with the new Regulation (EU) 2017/745 is made the obligation to assign to each device a UDI identification code.