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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

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 26th, 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.

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Manufacturers, authorized representatives, importers, and distributors are no longer mere subjects in a commercial chain but become active protagonists in ensuring the safety of the device throughout its life cycle.

fabbricante
Manufacturer

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

mandatario
Authorized representative

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

importatore
Importer

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

distributore
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.

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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.

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PMS: Post-Market Surveillance

A genuine post-market surveillance (PMS) system has been introduced, which is one of the fundamental components of the entire system created by the MDR legislator.

Through this surveillance, the manufacturer systematically collects data regarding compliance with essential safety requirements with the aim of making 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.

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Are you one of our Distributors for medical device products?

plettro

Are you a Bericah Exclusive Customer for private label medical device products?

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DO YOU HAVE ANY DOUBTS ABOUT THE MDR REGULATION?
CONTACT US NOW AND ARRANGE A TRAINING SESSION WITH ONE OF OUR REPRESENTATIVES.

We will help you better understand the obligations, responsibilities, risks, and sanctions introduced by the MDR Regulation.

medicale@bericah.it (+39) 0444 240522

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For further information on the MDR or Current Regulations, please contact our Quality Office

+39.0444.240522 qualita@bericah.it

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Summer Break Notice

Our offices will be CLOSED FOR A SHORT SUMMER BREAK from August 11th to August 20th, inclusive.

Please note that for all DELIVERIES to be made by August 8th, the final deadline for order acceptance is August 1st, 2025. All orders received after August 1st, 2025 may be delivered during the week of August 25th to August 29th, 2025.

For any specific needs, please contact our Sales Office.

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