MDR - Bericah

EU Regulation on Medical Devices

MDR Regulation

EU Regulation 2017/745 (MDR Regulation, acronym for Medical Device Regulation) has modified the rules regarding the production and marketing of medical devices.

The initial regulation for medical devices dates back to the 1990s when three directives were issued on the subject: Directive 90/385/EEC, Directive 93/42/EEC, and Directive 98/79/EEC.

The need to revise these directives led to the issuance of EU Regulation 2017/745.

MDR Regulation strengthens conformity assessment procedures and market surveillance of medical devices, while introducing provisions to ensure their traceability.

It sets high standards for the quality and safety of medical devices to meet the safety requirements associated with such products.

Finally, the MDR places particular attention on identifying the economic operators involved in the supply chain of medical devices and their respective responsibilities.

This regulation has been applicable since May 26^th, 2021.

What you need to know:

One of the first activities that the manufacturer must carry out is to determine whether, in light of the MDR (Medical Device Regulation), a product falls within the definition of a medical device and to understand if the risk class has potentially changed.

In this regard, it should be noted that Regulation 2017/745 contains a broader definition of a medical device compared to the past.

As a result, it applies to a range of products that may not have a medical purpose but have been included in the concept of a medical device for safety reasons (for example, non-corrective contact lenses, liposuction equipment, hair removal lasers, etc.).

Furthermore, the MDR provides a better definition of nanomaterials and regulates in much more detail the risk class of devices that incorporate nanomaterials.

One of the major innovations of the MDR is the more precise regulation of the obligations and responsibilities of the so-called economic operators: manufacturers, authorized representatives, importers, and distributors.

Una delle prime attività che il fabbricante deve svolgere è decidere se, alla luce del regolamento MDR, un prodotto rientra o meno nella definizione di dispositivo medico e capire se è cambiata, eventualmente, la classe di rischio.

A tale proposito va evidenziato che il regolamento 2017/745 contiene una definizione di dispositivo medico più ampia rispetto al passato.

Esso si applica così ad una serie di prodotti che non hanno una destinazione di uso medico ma che, per ragioni di sicurezza, si è preferito includere nella nozione di DM (per esempio: lenti a contatto non correttive, apparecchiature per la liposuzione o laser per la rimozione dei peli ecc.).

Inoltre il regolamento MDR definisce meglio cosa si intende per nanomateriale e regola in maniera molto più dettagliata la classe di rischio dei dispositivi che incorporano i nanomateriali.

Una delle maggiori novità del regolamento MDR è poi la regolamentazione, molto più precisa, degli obblighi e responsabilità in capo ai cosiddetti operatori economici: fabbricante, mandatario, importatore, distributore.

Manufacturer

A manufacturer commercializes a medical device in accordance with the MDR under their own name or brand.

Authorized representative

An authorized representative carries out the activities defined in the mandate on behalf of a manufacturer located outside the EU.

Importer

An importer places a medical device on the EU market that is compliant with the MDR and originates from a third country.

Distributor

A distributor makes a medical device available on the EU market in compliance with the MDR, until the moment of its being put into service.

The UDI System

Another important innovation is the traceability of medical devices through a new identification system called the Unique Device Identification (UDI) system.

It involves a unique code (numeric or alphanumeric) associated with a medical device that allows for clear and unambiguous identification of devices placed on the market and facilitates their traceability.

The identification consists of two main elements: the Device Identifier (UDI-DI) and the Production Identifier (UDI-PI).

Both elements provide access to useful information about the device.The unique identification of devices enhances incident reporting, facilitates the potential recall of devices posing a safety risk, contributes to the fight against counterfeiting, and increases patient safety. The unique identification of devices will work alongside the current labeling requirements for medical devices without replacing them.

EUDAMED: The New European Database for Medical Devices

A fundamental aspect for achieving the objectives of the regulation is the European database for medical devices (EUDAMED).

Its goal is to provide an updated snapshot of the lifecycle of medical devices available in the European Union.

This unique database is based on the creation of six interconnected modules that, once completed, will certainly improve transparency and coordination of information.

PMCF: Post-Market Clinical Follow-up System

A proper post-market clinical follow-up (PMCF) system has been introduced, which is one of the key elements of the entire system created by the MDR legislator.

Through this surveillance, the manufacturer systematically collects data on compliance with essential safety requirements in order to make any necessary improvements.

PRRC: Person Responsible for Regulatory Compliance

The MDR Regulation also includes another crucial change: the requirement to appoint within the medical device company a person responsible for regulatory compliance (PRRC).

The regulation stipulates that this obligation lies with both the manufacturer and the authorized representative.

But what does the PRRC actually do? They act as an internal “guardian” who ensures the supervision of device manufacturing, oversees post-market surveillance of medical devices, and exercises vigilance.

All the tasks of the PRRC are outlined in Article 15 of the MDR Regulation.