MDR, Regulatory

LEGISTRATION OF MEDICAL DEVICES IN ITALY: WHAT’S CHANGING NOW?

For some years now, the medical device sector has been going through a phase of innovation and development that seeks to exploit the best technological solutions for prevention, diagnosis and treatment in healthcare.
In this regard , on 5 May 2017 a new regulation governing this sector was published in the Official Journal of the European Union.
The entry into force of these regulations, which form the Regulation (EU) 2017/745 and the Regulation (EU ) 2017/746 and will replace regulations in force for over 20 years, it was scheduled for May 2020 but, due to the SARS-CoV-2 pandemic, it was postponed to May 26, 2021 with full application of the regulation on medical devices – in vitro diagnostics scheduled for May 26, 2022.
These regulations aim to standardize and aggregate the European medical device market, ensuring its optimal functioning thanks to a solid regulatory framework , clear and transparent, favoring new innovative technologies but always maintaining a high level of safety and quality.

THE CIRCULAR OF NOVEMBER 12, 2021
On November 12, 2021, the General Directorate of Medical Devices and the Pharmaceutical Service published a circular in which the applications of the new regulation are more clearly explained; in particular, the text is intended to expose the following information:

  1. Implementation of the Regulation: the implementation of new regulatory acts, of course, is intended to be mandatory for the whole sector, even if there are pre-existing national regulations that conflict with it, as Community regulations such as this – valid for the whole European Union – have a higher value.
  2. National database of medical devices: the creation of Eudamed, a European database of medical devices, is planned, with the aim of collecting and process information relating to the sector market. At the moment, however, Eudamed is not yet operational: therefore, the pre-existing provisions will continue to be applied.
    When the Database is finally active, time will be provided to comply with the obligations and provisions of the new Regulation.
  3. Manufacturers of bespoke devices: it is important that bespoke devices pass all conformity assessment procedures according to the new regulations.
  4. Legacy devices: new and specific have been defined for legacy devices standards for post-market surveillance, market surveillance, surveillance, registration of economic operators and devices and certification notifications.
  5. Notified bodies: from 26 May 2021, notified bodies are no longer authorized to issue certificates according to Directives 90/385 / EEC and 93/42 / EEC. However, the Notified Body remains responsible for overseeing all devices it certified before May 26, 2021.
  6. Advertising: There are no major changes in the rules relating to advertising, as the matter in the new Regulation is compatible with the pre-existing Art 21 of Legislative Decree 46/97 of 2006.
  7. Use of harmonized standards: only devices that comply with the harmonized standards published in the Official Journal of the European Union are considered to be in compliance with the laws of the new Regulation contemplated by these standards.
  8. Products of Annex XVI: the Regulation also refers to the directives relating to products that have no intended medical use, present in Annex XVI.
  9. Tariffs: each Member State of the EU has the possibility to request tariffs for carrying out the activities envisaged by the new Regulation in question.
  10. Sanctions: the national legislators of the Member States define the sanctions to be applied in the event of violation of the rules; after notifying the Commission of the Sanctions Directives on 25 February 2021, each Member State is required to notify the Commission of any subsequent changes or modifications to them.

Selmedico immediately undertook to comply with the new rules of traceability, transparency and surveillance throughout the purchase process: not only to adapt to the new European regulations, but also to maintain the high quality standard it has always distinguished by the company and its partners.