The latest Medical Devices Virtual Talk was dedicated to Emoled, a start-up resulting from research in the field of photonics; the company is known on the market for the homonymous medical device, a photobiomodulation system that uses blue light for the therapy of skin lesions of various kinds, both acute and chronic.
In recent years, Emoled has experienced a strong commercial development, especially at an international level: this has led the company to measure itself not only with the new 2017/745 regulation, but also with the laws and requirements of non-EU countries.
As an active device, Emoled has been classified and certified in accordance with Regulation 9 of Directive 93/42/EEC and is currently in Class Iia. In addition, in 2018 the company obtained the ISO 13485:2016 certification.
Generally the “registration” procedures of a medical device vary depending on the state of destination; in some cases a Free Sale Certificate is sufficient, while in others it is necessary to provide a more substantial documentation. There is also the possibility that the classification rules of the device are different from those of Europe, so, in any case, the first step is the verification of these rules, because its outcome depends on the type of procedure to be followed for the registration of the device itself.

Emoled story

Recently established (2016), Emoled is a collaboration between LENS (European Laboratory for Non-linear spectroscopy), IFAC (the institute of applied physics of CNR) and Life4tech. In particular, the latter is the company that has cured the transition from research to the actual market, thus giving rise to the homonymous medical device.
In order to comply with the regulatory requirements, specific to each State in which the marketing takes place, Emoled relies on local distributors, who provide regulatory referents as a guide for the path to follow and the documentation to be provided.

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”.

3. CE marking in accordance with the directives: what was the most difficult challenge in the transition to the new regulation? “Surely the production of a technical documentation conforming to Annex II and the drafting of the PSUR (Periodic Safety Update Report), because, for the DM does not exist a template. However, what will have the greatest impact, will be the adaptation to all the harmonised standards, applicable to the Ministerial Decree, expected by 2024; integrating these standards into our documents will be a great challenge”.
4. How can the situation in the UK be described? “UK is no longer part of the European community, therefore the MDR does not remain in force in this country: consequently, it is necessary to follow the same approach as for a third country, preparing a new certification. However, even the UK provides for a transitional period for German marks already on its market, in addition to a person responsible for compliance with the legislation”.

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:

  1. registration of economic operators
  2. UDI device recording
  3. certified bodies
  4. post-market surveillance and surveillance
  5. clinical investigations
  6. 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.