The new Regulation (EU) 2017/745 on medical devices, which came into force on 25 May 2017 and which repeals the previous Directive 93/42/EEC, introduces various changes to the regulatory framework governing the placing of medical devices on the European market.
These are significant changes that involve the broadening of the product definition, one better device traceability, more effective control for technical documentation, as well as improved clinical evaluation and post-market surveillance. These changes correspond to new obligations for manufacturers, but also of importers and gods distributors of the medical devices themselves, without prejudice to the fact that manufacturers of medical devices approved under the old regulation have a three-year transition period – until 26 May 2020 – to meet the requirements of the new MDR (Medical Device Regulation).
Expanding the scope of application
The scope of application of the European Regulation 2017/745 involves i medical devices for human use and accessories for such devices, as well as clinical investigations relating to such devices and accessories, when these are conducted in the Union. The following fall within the scope of application of the Regulation: products that have no intended medical use, to which the entire Annex XVI is dedicated. Specifically, it involves:
- Contact lenses or other items intended to be inserted into or onto the eye.
- Products intended to be introduced totally or partially into the human body using invasive surgical instruments for the purpose of modifying the anatomy or for fixing parts of the body with the exception of tattoo and piercing products.
- Substances, combinations of substances or elements intended to be used for facial fillings or other skin or mucosal fillings through subcutaneous, submucosal or intradermal injection, except those for tattoos.
- Equipment intended to be used to reduce, remove or destroy fatty tissue, such as liposuction, lipolysis or lipoplasty equipment.
- Equipment emitting high-intensity electromagnetic radiation (e.g. infrared, visible light and ultraviolet) intended for use on the human body, including coherent and non-coherent, monochromatic and broad-spectrum sources, such as lasers and high-intensity pulsed light equipment for skin photorejuvenation, tattooing or hair removal or other dermal treatment.
- Equipment intended for brain stimulation that applies electrical currents
Furthermore, products specifically intended for cleaning, disinfection or sterilization of the medical devices themselves are considered medical devices - and therefore subject to the application of the Regulation.
The introduction of the "person responsible" for compliance with the law
Article 15 of the Regulation regulates that device manufacturers are required to identify a person within their organization who will be responsible for all aspects relating to the compliance with the new legislation, with the exception of micro-enterprises and small businesses which will be able to appoint a person from outside the organisation, having them available on a continuous basis. The person responsible for compliance with the legislation is responsible for ensuring that:
- The conformity of the devices is adequately controlled in accordance with the quality management system under which the devices are manufactured before the release of a device;
- The technical documentation and the EU declaration of conformity are drawn up and updated;
- The post-marketing surveillance obligations referred to in Article 10, paragraph 10 of the Regulation are satisfied;
- The reporting obligations described in articles 87 to 91 of the Regulation are satisfied;
- In the case of devices under investigation, the declaration referred to in Annex XV, chapter II, point 4.1 of the Regulation is issued.
The transfer of the manufacturer's obligations to importers or distributors
According to what is specified in Article 16 of the new Regulation, a distributor, an importer or another natural or legal person assumes the obligations of manufacturers where he makes a device available on the market under his own name, trade name or registered trademark, except where a distributor or importer concludes an agreement with a manufacturer under which the manufacturer is indicated as such on the label and is responsible for compliance with the obligations incumbent on manufacturers pursuant to the Regulation itself.
Furthermore, the obligations of the manufacturers fall on the figure of the distributor or importer, where this is the case change the intended use of a device already placed on the market or put into service or when you modify a device already placed on the market or put into service in such a way that its compliance with the applicable requirements may be compromised.
UDI Traceability and the EUDAMED Database
The new Regulation emphasizes the need for better traceability of devices. For this reason, the implementation of theUnique Device Identification (UDI – Unique Device Identification). This provision allows identification and facilitates traceability of devices, producing a UDI (specific for a manufacturer, for a device and for production) to be placed on the label or packaging. The UDI will therefore be registered by economic operators, healthcare institutions or healthcare professionals and monitored thanks to the establishment of an electronic system for the unique identification of the device.
To assist the provisions of the Regulation, the Commission prepares and manages the European medical device database («Eudamed»), which has the function of allowing the public to be adequately informed about the devices placed on the market, the clinical investigations, the related certificates issued by the notified bodies and the economic operators involved. Furthermore, Eudamed has a focal role in enabling the unique identification of devices in the internal market and facilitating their traceability, as well as in allowing the competent authorities of the Member States and the Commission to carry out their tasks in relation to the Regulation, strengthening the mutual cooperation.
The appointment of Notified Bodies
Each Member State has the task of appointing an Authority - re-evaluated three years after the first appointment and subsequently every four years - which is responsible for the development and implementation of the procedures necessary for the evaluation, designation and notification of bodies and for their surveillance. To meet the requirements relating to notified bodies, they must permanently have administrative, technical and scientific staff and staff with clinical experience made up, where possible, of employees.
For each device, manufacturers shall plan, establish, document, apply, maintain and update a post-market surveillance system in a manner proportionate to the risk class and appropriate to the type of device. This surveillance system has the function of systematically collecting, recording and analyzing data on the quality, performance and safety of a device during its entire life, determining - where necessary - any preventive and corrective actions.
Post-market surveillance is an integral part of the manufacturer's quality management system, which has the obligation to report incidents relating to devices made available on the Union market and any corrective action to be taken to the competent authorities.
The necessity of meet regulatory requirements for new medical devices and the necessary re-evaluation of currently approved devices to adapt to the new Regulation, mean that manufacturers, importers and distributors must be informed and updated on expected changes and product compliance processes.
THE manufacturers, The importers and of distributors who operate in the European market, therefore, can turn to the experience of Sicom testing to verify and implement the conformity of the devices.
Sicom Testing has experience in testing of motorized furniture components and Class I medical devices such as beds, chairs and lifts.
To request further information on this topic, write to firstname.lastname@example.org
or call +39 0481 778931.