MDR: the new Medical Device Regulation

Euronda is one of the first Italian companies to obtain MDR certification for all its (class I, IIa and Iib) Medical Devices. To understand the importance of this achievement, provided below is an explanation of the main implications of the new Regulation for the entire medical supply chain, from the manufacturer to the patient.

• What is the MDR Regulation (EU) 2017/745, and what has changed?
• The need for new European legislation on medical devices
• Why it is important for dentists and patients
• The most significant new points in the MDR for distributors
• MDR and the UDI system: Identification and Traceability

The new Regulation (EU) 2017/745 or MDR (Medical Devices Regulation) is the European regulation that defines the standards and requisites that all manufacturers and distributors must comply with in order to place a Medical Device (MD) on the European market. 

The MDR arises from the need to adapt legislation on medical devices to the requirements of the future, so as to prepare a sound, appropriate, transparent, sustainable regulatory framework and to harmonise the functioning of the internal market of the European Union.

The new Regulation came into force on 25 May 2017 (with full implementation from 26 May 2021). As well as supplementing and replacing the previous Directives 90/385/EEC and 93/42/EEC, it establishes more stringent requisites and measures, aligned with the evolution of the medical device market at international level. The Regulation is a legislative act that is immediately binding and mandatory for all public or private entities, which are obliged to comply with EU law. This means that – unlike the previous Directives – all EU Member States are obliged to comply with it in full without a national transposition measure.

The MDR regulation derives from the intention to give the pertinent authorities and entities greater control over companies, in order to strengthen monitoring and traceability subsequent to the sale of the devices, and to prevent the entry into the European market of medical devices that are potentially dangerous for operators and patients.

The new Regulation seeks to offer improved protection for patients and users of medical devices, guaranteeing transparency and information. For dentists and dental clinics, this offers the advantage of an informed choice to ensure safe, traced and controlled solutions, and there is also the obligation to check very carefully that the devices used are MDR compliant and CE marked.

The regulation places the responsibility for verification on all operators in the chain, with legal consequences and penalties for those who produce, market and put into service a device without the CE marking or certificate of conformity.

The new rules aim to ensure:

• improved protection of public health and the safety of patients and users. The requirements that must be met for proper preclinical and clinical evaluation have been strengthened, and stricter rules have been introduced regarding the use of hazardous substances (SVHC and endocrine disruptors);
• a comprehensive public EU database on medical devices (EUDAMED) that will offer a picture of the life cycle of all products available on the EU market;
• a new identification system based on a unique device identifier (UDI) that will make it easier to trace medical devices and to promptly withdraw devices that present a safety risk;
• a sound financial mechanism to ensure that patients receive compensation in the event that they receive faulty products.

Euronda’s commitment

The Euronda Quality Department has always endeavoured to guarantee the compliance of its medical devices, in order to respond promptly to regulatory changes and to protect customers, operators and patients. Euronda class I medical devices have been compliant with the new Regulation since May 2021. The company obtained certification in September 2021 for all the higher-class medical devices, including all the Pro System autoclaves (EXL, E10, E9 and E8).

Manufacturers

The changes introduced by the MDR Regulation mean that manufacturers and distributors will have to fulfil more obligations. Among the most important innovations for manufacturers:

• Introduction of changes to the classification and reclassification of a number of medical devices, although the 4 risk classes established by the previous regulation (I, IIa, IIb, III) have been maintained;
• Strengthening of the system for clinical investigations and monitoring subsequent to sale, thus reducing the risks posed by unsafe devices;
• Production of more technical documentation and findings;
• Identification of a Person Responsible for compliance with the Medical Devices Regulation MDR 2017/745 and all the aspects regarding compliance with the requisites of the new regulation, documenting the specific qualifications of the person with regard to the activities required;
• Definition of the role and responsibilities of the Economic Operators involved in the import and distribution of medical devices: Manufacturer, Authorised Representative, Importer and Distributor.
• More restrictions on own brand labelling (OBL), promoting the clear indication of the original equipment manufacturer (OEM) on the label of the medical device.

Distributors

Distributors will also play an important role in maintaining the traceability of medical devices. They will be called upon to cooperate with manufacturers or agents in order to ensure an appropriate level of trackability of medical devices.

For distributors, the same applies as for operators: they too are required to verify that the devices placed on the market are compliant and CE marked and that the activities carried out by the manufacturer are in compliance with the MDR:

1. Checking of the label and instructions of the device, in the official language of the Member State in which the device is to be sold;
2. Verification of the proper application of the UDI to the medical device, and for products imported from non-EU countries, verification that the name of the authorised representative and their contacts are present on the device or its packaging and on the accompanying documentation;

Keeping of a register of complaints regarding non-conforming devices, recalls and withdrawals. All information shall be made available to the other Economic Operators to enable them to handle reports and non-conformities as effectively as possible.

A relevant feature introduced by the new regulation is the Unique Device Identification (UDI) system (Article 27 MDR and Article 24 IVDR), which will apply to all medical devices placed on the EU market.

The UDI will be a barcode, Datamatrix code or any other machine-readable code, used to improve the identification and traceability of devices, as well as the effectiveness of post-sale activities related to security and monitoring by the competent authorities.

The UDI shall be used to identify devices uniquely and unambiguously, either as single units or as devices packaged with other units, or in the case of reusable devices, by direct marking of the device itself. Where possible, each medical device and, as appropriate, each level of their packaging will have a UDI indicated on the labels. UDIs will be added to labels gradually, so that the process can be completed by 2027, depending on the risk class of the device.

The MDR is a major challenge for the entire medical supply chain in terms of compliance and investment. At the same time, it is also an opportunity to create a more rigorous, transparent market that offers doctors, dentists and consumers a guarantee of protection.

Euronda always puts protection and quality first. We have therefore embarked with enthusiasm on the complex process of certification, because it is part of our mission: to guarantee the complete safety of instruments, the dental environment and above all of operators and patients.