EU Regulation 2017/745, known as the Medical Device Regulation (MDR), has introduced significant changes to the rules governing the production and marketing of medical devices in the European Union.
The first 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/EC. These directives aimed to raise the standards of quality and safety for medical devices and increase patient safety. In 2017, Regulation (EU) 745 was enacted.
These new provisions have a significant impact on the industry and require a comprehensive understanding from all stakeholders involved.
In this article, we will explore the key implications of the MDR and how they affect medical device manufacturers, distributors, and consumers.
Definition of Medical Device and Risk Classification
One of the first challenges that manufacturers must face is determining whether a product falls within the definition of a Medical Device according to the MDR and if its risk classification has changed.
The MDR has expanded the definition of Medical Device, including a wide range of products that were not previously considered as such.
This includes products such as non-corrective contact lenses, liposuction equipment, and laser hair removal devices.
Furthermore, the MDR has provided a clearer and more detailed definition of nanomaterials and established specific rules for the risk classification of devices incorporating such materials.
Medical Devices that use nanomaterials can present unique risks, and it is therefore essential to apply appropriate risk classification and implement necessary safety measures.
New Definition of Medical Device under the MDR
Any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used alone or in combination for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation, or compensation for an injury or disability;
- investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state;
- providing information via in vitro examination of samples derived from the human body, including donated blood and tissues, and which does not achieve its principal intended action on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means.
The following products are also considered medical devices:
- devices for contraception control or support;
- products specifically intended for the cleaning, disinfection, or sterilization of devices referred to in Article 1, paragraph 4, and those referred to in the first sentence of this point.
The MDR pays particular attention to the identification and responsibilities of economic operators involved in the supply chain of medical devices.
In addition to the manufacturer, who has the primary task of ensuring compliance and safety of the devices, the regulation also involves authorized representatives, importers, and distributors.
In the past, authorized representatives, importers, and distributors mainly played a role of intermediaries in the commercial chain.
However, with the entry into force of the MDR, these actors become active protagonists in ensuring the safety of devices throughout the product’s lifecycle.
Medical Device Traceability through the UDI System
One of the important innovations introduced by the MDR is the implementation of the Unique Device Identification (UDI) system to ensure traceability and improve the safety of medical devices.
The UDI system strengthens incident reporting and facilitates the withdrawal of devices that pose a safety risk.
Manufacturers must assign a UDI code to each medical device and include it in the product labeling.
Understanding and correctly implementing the UDI system is crucial to ensuring compliance with the provisions of the MDR and the safety of medical devices on the market.
Eudamed - The European Database on Medical Devices
A fundamental aspect for the success of the MDR is the implementation of Eudamed, the European Database on Medical Devices.
Eudamed provides a comprehensive overview of the lifecycle of medical devices available in the European Union, improving transparency and information coordination.
This unique database is based on six interconnected modules that allow for the collection, storage, and sharing of important information on medical devices.
Proper implementation of Eudamed is essential to ensure compliance with the MDR and facilitate monitoring and surveillance of medical devices on the market.
The Role of PRRC
The MDR introduces an important change in the medical device industry by requiring the appointment of a Person Responsible for Regulatory Compliance (PRRC) within manufacturing companies.
The obligation to appoint a PRRC lies with the manufacturer. The PRRC plays an internal “guarantor” role and is responsible for ensuring oversight of the manufacture of medical devices and post-market surveillance.
The responsibilities of the PRRC are outlined in Article 15 of the MDR and include monitoring compliance, risk management, surveillance of medical devices on the market, and handling incident reports.
Furthermore, a post-market clinical follow-up (PMCF) system has been introduced for the systematic collection of data on the safety of medical devices and for identifying any necessary improvements.
PMS: Post-Market Surveillance System
Another important innovation introduced by the MDR Regulation is the Post-Market Surveillance System (PMS).
This system represents a key element of the entire framework created by the legislator to ensure the continuous safety of medical devices.
The PMS involves the systematic collection of data on the manufacturer’s compliance with essential safety requirements.
These data are used to make continuous improvements to medical devices and to manage any risks or issues that may arise after marketing.
The PMS is a dynamic process that requires constant monitoring and a commitment to the safety of medical devices.
Our Support for the MDR
Do you have any doubts about the MDR?
Contact us for a training session with our experts.
If you are a distributor of medical devices or a customer interested in Exclusive (DM) products in Private Label, it is crucial to fully understand the obligations, responsibilities, risks, and sanctions introduced by the MDR.
We offer specialized support to help you navigate through the complex implications of the regulation.
Contact us now to arrange a training session with our experts and ensure compliance and safety of marketed medical devices.
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In conclusion, the MDR represents an important step forward in the regulation and surveillance of medical devices in the European Union.
Its provisions aim to ensure high standards of quality and safety to protect the health of patients.
It is essential that manufacturers, authorized representatives, importers, and distributors fully understand the new regulations and comply with them to ensure compliance and safety of medical devices on the market.
Choose safety and compliance for the success of your medical devices.