The new Regulations (I) 2017/745 on medical devices, entered into force on 25 May 2017 and repealing the former Directive 93/42 / EEC, It introduces various changes in the regulatory framework governing the placing on the European market for medical devices.
These are significant changes that involve the expansion of the product scope, a best tracking devices, more effective control for technical documentation, as well as better clinical and post-marketing surveillance. These changes correspond new obligations on manufacturers, but also of importers and distributors the medical devices themselves, it being understood that manufacturers of medical devices approved under the old regulation have provided a transitional period of three years – until the 26 May 2020 – to meet the requirements of the new MDR (Medical Device Regulation).
The expansion of the scope of application
The scope of European Regulation 2017/745 coinvolge i medical devices for human use and accessories for such devices, as well as clinical investigations relate to such devices and accessories, when these are carried out within the Union. Included within the scope of Regulation, i products that have no intended medical use, which is dedicated to the entire Annex XVI. It deals with, in particular, of:
- Contact lenses or other elements intended to be introduced into or on the eye.
- Products intended to be totally or partially introduced into the human body using invasive surgical instruments of the type in order to modify the anatomy or for the fixation of body parts with the exception of products for tattoos and piercings.
- Substances, associations of substances or elements intended to be used for filling facial or other skin filling or to the mucous membranes through subcutaneous injection, submucosal or intradermal, except for tattoos.
- Equipment intended to be used to reduce, remove or destroy the fatty tissue, such devices for liposuction, lipolisi on lipoplastica.
- Equipment emitting electromagnetic radiation at high intensity (for example infrared, visible light and ultraviolet) intended to be used on the human body, including coherent and not coherent sources, monochromatic and broad-spectrum, as lasers and light equipment pulsed high intensity for skin rejuvenation, tattoo or hair removal or other treatment dermal.
- Equipment intended for brain stimulation that apply electrical currents
They are considered medical devices – and therefore subject to the application of Regulation – Moreover, products specifically intended for cleaning, disinfection or sterilization of medical devices themselves.
The introduction of “Responsible person” compliance with legislation
The article 15 the Regulations establish that device manufacturers are required to identify a person in their organization who will be responsible for all aspects regarding the compliance with new regulations, except for micro-enterprises and small businesses that may appoint a person outside the organization, having it available in a continuous manner. The person responsible for compliance with legislation responds to the task of ensuring that:
- The compliance of the devices is adequately controlled in accordance with the quality management system according to which the devices are manufactured before the release of a device;
- The technical documentation and the EU declaration of conformity be drawn up and updated;
- Let satisfied the post market surveillance obligations of Article 10, section 10 of the Regulations;
- Are to be satisfied with the reporting requirements described in Articles 87 a 91 of the Regulations;
- In the case of devices under investigation, It is released the statement in Annex XV, Chapter II, point 4.1 of the Regulations.
The transfer of the latter's obligations to importers or distributors
According to specified by Article 16 New Regulations, a distributor, importer or another person or entity assume obligations of manufacturers if put a device available on the market under its own name, their trade name or registered trade mark, except in cases where a distributor or an importer conclude an agreement with a manufacturer according to which the manufacturer is identified as such on the label and is responsible for meeting the obligations of manufacturers under the same Regulation.
The obligations of manufacturers, Moreover, fall on the figure of the distributor or importer, if this change the intended use of a device already placed on the market or put into service or when changing a device already placed on the market or put into service in such a way that its compliance with applicable requirements may be compromised.
Traceability UDI and the Bank EUDAMED Data
The new regulation emphasizes the need for better tracking of devices. For this, It is established in the Articles 25-34, the implementation of’Unique Identification Devices (UDI – Unique Device Identification). Such an arrangement permits the identification and facilitates the traceability of devices, going to produce a UDI (specific to a manufacturer, for a device and for the production) to be affixed on the label or packaging. The UDI will therefore be registered by traders, health care institutions and health professionals and monitored through the establishment of an electronic system for the unique identification of the device.
To assist the provisions of Regulation, the Commission shall establish and maintain a European databank for medical devices («Eudamed»), whose function is to allow the public to be properly informed of the devices placed on the market, clinical investigation, the relevant certificates issued by notified bodies and the economic operators concerned. The Eudamed has, Moreover, a focal role in enabling the unique identification of the devices in the internal market and to facilitate the traceability, and to allow the competent authorities of the Member States and the Commission to perform its tasks in relation to Regulation, strengthening mutual cooperation.
The appointment of Notified Bodies
Each Member State has the task of appointing authority – reassessed three years after the first appointment and then every four years – which it is responsible for the preparation and completion of the necessary procedures for the assessment, designation and notification of bodies and for their monitoring. To meet the requirements for notified bodies, they must have permanently administrative staff, and technical and scientific staff with clinical experience made, where possible, by employees.
The post-marketing oversight
For each device manufacturers ensure schedule, establish, documentation, to apply, maintain and update a post-marketing surveillance system in a proportionate manner to the risk class and appropriate to the type of device. This surveillance system has the function of collecting, recording and analyzing quality data, the performance and safety of a device during its entire life, determining – where necessary – any preventive and corrective actions.
The post-marketing surveillance is an integral part of the management system of the manufacturer's quality, which it has a duty to report to the competent authorities accidents related to devices made available on the Union market and any corrective action taken.
The necessity of meet regulatory requirements for new medical devices and the necessary re-evaluation of the currently approved to adapt to the new Regulation, mean that manufacturers, importers and distributors must be informed and updated on changes contemplated and on the product compliance processes.
I manufacturers, the importers ed i distributors operating in the European market, therefore, They can turn to the experience of Sicom testing to verify and enforce compliance of the devices.
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