The New Regulations on Medical Devices – the Challenges for Companies

By adoption of the new rules governing the legal regulations on medical devices in the EU market the business faced new challenges which they seem will not manage to respond within the required terms. The Regulation of the EU Parliament on Medical Devices (MDR) became effective on 26 May 2017 with a transitional period of three years – until 26 May 2020. This transitional period aims at giving an opportunity for the companies to bring their business in compliance with the new legislation.
Although this transitional period seems long at first sight, it appears that there are a few companies who are familiar with the new legal amendments, and these who have taken steps on ensuring compliance with MDR are far less in number. It does not concern the business only, but the institutions in Bulgaria too. The lack of publicity about the changes on the part of the governmental authorities may mean bankruptcy for the business of these companies who rely on getting help from the government for consultations in relation to fulfillment of the legal requirements for medical devices.

Which companies are concerned?

The shortest answer is all.

MDR lays under an obligation producers, distributors, importers, authorized representatives to comply with the stricter rules protecting consumers.
In Bulgaria most of the business dealing with medical devices is performed by distributors and importers, as a company often combines both functions. Till now there was no regulation on the importer’s duties as all companies importing medical devices were considered as wholesalers/distributors. Introduction of the figure of “the Importer” enabled the distinguishing of companies dealing with import and such that have as their scope of business distribution services. This distinguishing is useful in terms of allocation of the duties and liability between the companies.

What obligations will the Importer has when the MDR becomes effective?

The Importer is the first party who launched the medical devices in the EU market. Being the first one in the chain, the Importer has the obligation to check:
– Conformity of the Medical Device – if it has a CE marking and a Declaration of Conformity;
– If the producer is identified and if there is an appointed authorized representative;
– If the device is labeled according to the EU and Bulgarian law and if it is accompanied by the required documents, including the newly introduced information about the Importer placed on the device’s label;
– If there is a Unique Device Identification (UDI) determined by the manufacturer according to the Unique Device Identification System (if applicable only);
– Check for device registration and obligation for registration of the Importer in the electronic system for generation of the unique registration number.

Considering the lack of obligations for the importers until adoption of the MDR, what makes an impression here is the clear regulation and the numerous obligations of these parties. The purpose is to ensure traceability of medical devices, diminishing the risk and experience in engaging the responsibility of more parties along the chain.

What obligations will the Distributor has when the MDR becomes effective?

The Distributor has similar obligations to these of the Importer. Before starting marketing a medical device, the Distributor shall check:
– Conformity of the Medical Device – if it has a CE marking and a Declaration of Conformity;
– If the obligatory information that the manufacturer must provide is available;
– If the Importer has fulfilled its obligations for device labeling;
– If there is a Unique Device Identification (UDI) determined by the manufacturer according to the Unique Device Identification System (if applicable only);
– A new thing here is the regulation of the distributor’s duty for cooperation with the governmental authorities – a duty that existed ‘unwritten’ until its regulation by the MDR.

Where is the trick?

The review of the obligations shows that despite of the enhanced engagement of the Importer and the Distributor with respect to the risk control and traceability of medical devices, if they start their preparation on time, most companies may fulfill the MDR requirements.

Then why there is so much noise about that?

If you read carefully Article 16 MDR, it will become clear that the lawmaker has created a fiction affecting a huge part of medical device distributors and importers.
According to the legal regulations, an importer or another individual or corporate entity shall assume the obligations of manufacturers if:
– it markets a device under its own name, registered trade name or registered trademark, except in the cases where the distributor or importer signs an agreement with the manufacturer, whereby the manufacturer is indicated as such on the label and is responsible for fulfillment of the requirements imposed by the manufacturers according to this regulation;
– it changes the purpose of use of a device that has already been launched in the market or put into operation;
– it modifies a device that has already been launched in the market or put into operation so that it may affect the compliance with the applicable requirements.

Introduction of the legal fiction facilitates the governmental authorities to seek responsibility from a larger circle of subjects without the need for proving any connection between them. For example, if the distributor, branded a device purchased from China with its own mark, could so far rely on default by the manufacturer regarding the device conformity, by introduction of the new rule, the responsibility for default in these obligations falls directly on it, because it itself is considered as a manufacturer.
The responsibility of the economic operators affected by the regulation is not limited to a formal check for fulfillment of the obligations of a third party.
This reading of the regulation lays under an obligation the distributors and importers, meeting the respective requirements, to fulfill all obligations of the manufacturer according to the regulation in terms of ensuring device conformity, clinical trials, operating quality system, etc.
The conclusion is clear – a number of distributors and importers will try to go as they did before, hopefully not to get “caught”, and other will dissolve their business. There is an exit – start working now and prepare for the coming changes. We, Petya Noycheva & Partners, will be glad to assist you on the way to the change and to contribute to your successful business.