The new Medical Devices Regulation MDR 745/2017, which repeals directive 93/42/EEC and subsequent amendments, came into force on 25 May 2017, and will be definitive at the end of a transition period of three years (until 26 May 2020).
An important part of the many important new aspects introduced by the new Regulation, compared with the previous directive, is the definition and the detailed obligations of all economic operators. In the previous directive, only the Manufacturer and the Agent in the EU were defined and identified in the distribution chain, with specific indication of their obligations and responsibilities, whereas the new Regulation also refers to Importers and Distributors.
It is important to emphasise here that, according to the new Regulation, our customers are identifiable as Distributors, as this is defined in Art. 2 as
any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market, up until the point of putting into service;
The general obligations of distributors are then listed in Article 14:
When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.
Unaware management of the Medical Device is therefore not permitted: distributors have to know the requirements that must be met for the manufacture of the Medical Device and can demand that the manufacturer provides all the documentation needed to prove conformity.
In the first place, it is essential for distributors to learn the general requirements of the new regulation, in order to allow them to recognise serious shortcomings or even clearly non-conforming devices.
In fact, paragraph 2 requires the following of the Distributor:
Before making a device available on the market, distributors shall verify that all of the following requirements are met:
- the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
- for imported devices, the importer has complied with the requirements set out in Article 13(3);
- that, where applicable, a UDI has been assigned by the manufacturers
But, most importantly, it is indicated that
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
It therefore follows that, if a distributor places a clearly non-conforming device on the market, it will be wholly liable for failing to comply with the control requirements laid down by the new regulation.
The distributor must therefore be informed and trained in the documentation needed to demonstrate conformity.
This is even more important for devices that are defined as low risk (Class I), which are not checked and controlled by a Notified Body and are declared as conforming through a self-declaration of the manufacturer.
Paradoxically, it is precisely these devices that are even more risky, due to the presence of products that have not been sufficiently checked unless they are clearly non-conforming.
This is the case of Class I electro-medical devices (beds, electric wheelchairs, disability scooters), which can simply be declared as conforming products through a self-declaration of the manufacturer, but which, in order to be considered as “up to standard”, and therefore “safe”, must comply with electrical safety medical standards.
The retailer is therefore entitled to ask the manufacturer to provide evidence that the products satisfy electrical safety standards, in order to be certain that they are conforming products.
For example, test reports and/or certificates issued by test laboratories in accordance with international standards IEC 60601-1 (Medical electrical equipment safety) and IEC 60601-1-2 (Electromagnetic compatibility of medical devices) are essential to demonstrating compliance with European regulations.
With entry into force of the new MDR 745/2017, the concept of “as long as nothing goes wrong” or “it’s not my problem, someone else manufactured it” no longer applies, and the entire distribution chain is responsible for checking and ensuring product conformity.