The new MDR

22/10/2021

The new MDR European Regulation for Medical Devices

Euronda is one of the first Italian companies to obtain MDR certification for all its Medical Devices (class I, IIa and IIb). In order to understand the importance of this milestone, the implications of the new Regulations for the entire medical supply chain, from manufacturer to patient, are briefly discussed below.  

What is the EU MDR 2017/745?

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 stems from the need to adapt medical device legislation to the needs of the future, so as to provide an appropriate, robust, transparent and sustainable regulatory framework that provides a consistent standard for the functioning of the EU internal market. 

The new regulation supplements the previous Directives 90/385/EEC and 93/42/EEC, and provides for stricter requirements and measures in line with the evolution of the global medical device market. 

It came into force on 25 May 2017, and was fully implemented on 26 May 2021, replacing the previous directives. 

MDR EU 2017/745: the need for a new regulation on medical devices

The MDR stems from the intention to give authorities and supervisory bodies more control over companies, in order treinforce the surveillance and post-marketing tracking of devices and avoid the placing on the European market of medical devices that are potentially dangerous for operators or patients. 

Why it is important for dentists and patients

The new Regulation aims to offer better and increased protection for the patient or user of the medical device, ensuring transparency and guaranteeing information. 

The new rules aim to ensure: 

  • better protection of public health and the safety of patients and users. The requirements to be met for proper pre-clinical and clinical evaluation have been strengthened, and stricter rules have been introduced on the use of hazardous substances (SVHC and endocrine disruptors); 
  •  comprehensive EU database on medical devices (EUDAMED) that will contain a living picture of the life cycle of all products available on the EU market. To ensure accessibility and transparency, much of the information on medical devices will be made publicly available;
  • a new device identification system based on a unique device identifier (UDI) that will facilitate the traceability of medical devices, facilitating the rapid recall of devices that present a safety risk;
  • a robust financial mechanism to ensure that patients are compensated if they receive defective products.

Euronda’s Quality Department has always strived to ensure that its medical devices conform to applicable standards in order to readily respond to changing regulations and to protect customers, operators and patients. Euronda Class I medical devices have conformed to the new Regulations since May 2021.

For higher-class medical devices, the company obtained certification in September 2021 of all Pro System autoclaves (EXL, E10, E9 and E8).

The most significant new points of the MDR regulation for manufacturers and distributors

Manufacturers

The main changes introduced by the MDR Regulation are aimed at increasing user and patient protection, by increasing the obligations manufacturers and distributors are subject to. The most important include: 

  • introduction of changes to the classification and reclassification rules of some medical devices, while maintaining the 4 risk classes present in the previous regulation (I, IIa, IIb, III);
  • strengthening of clinical investigations and post-sales surveillance, thus reducing risks from unsafe devices;
  • increased production of technical documentation and evidence;
  • identification of a Person Responsible for compliance with the Medical Devices Regulation MDR 2017/745 and all aspects of compliance with the requirements of the new regulation, documenting the specific qualifications of the person for the required activities;
  • definition of the role and responsibilities of Economic Operators involved in the import and distribution of medical devices: Manufacturers, Agents, Importers and Distributors;
  • 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. They will also be required to verify that the activities carried out by the manufacturer are compliant with the MDR, by: 

  • checking the label of the device and the instructions for use, in the official language of the Member State where the device is to be marketed;
  • checking that the UDI is correctly applied to the medical device and, in the case of products imported from non-EU countries, checking that the importer’s name and contact details are present on the device or packaging and in the accompanying documentation;
  • maintaining a register of claims regarding non-compliant medical devices, recalls or 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.

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 has always placed protection and quality at the top of its list of priorities, and has therefore enthusiastically embarked on the complex process of certification, as part of its mission to guarantee the total safety of the instruments, the dental environment and, above all, the operators and patients. 

Categories

Top