Medical Device Regulation

How does Medical2day BV comply with the MDR?

Medical2day BV places great importance on the quality, safety and traceability of medical devices. In our capacity as a distributor, we comply with the applicable obligations under European Regulation (EU) 2017/745 on medical devices, also known as the Medical Device Regulation (MDR).

Our role as a distributor

Medical2day BV acts as a distributor of medical devices, rather than as a manufacturer or importer. In this capacity, we carry out the applicable checks required under Article 14 of the MDR.

These checks include verifying that:

the device bears the CE marking and the required declaration of conformity has been drawn up;
the necessary product information and instructions for use are provided;
the importer’s details are indicated, where applicable;
a Unique Device Identifier (UDI) has been assigned, where applicable.

MDR and transitional provisions

The MDR has applied since 26 May 2021. We supply medical devices that meet the applicable legal requirements. This also includes devices that may still lawfully be made available under the previous Medical Devices Directive (MDD), in accordance with the statutory transitional provisions.

These transitional provisions apply only when the relevant conditions are met. The applicable deadlines depend, among other factors, on the device’s risk class and certification status.

If we have reason to believe that a device does not meet the applicable requirements, we suspend its supply until the non-conformity has been resolved. If a product becomes unavailable as a result, we inform the customers concerned as soon as possible and, where possible, discuss a suitable alternative.

CE certificates and declarations of conformity

We require our suppliers to make the necessary declarations of conformity available, together with certificates issued by a notified body, where applicable.

Do you need documentation for a specific product? On request, we will provide the available documents or obtain them from the relevant manufacturer or supplier. Please include the product name and reference number whenever possible.

Storage, transport and traceability

While medical devices are under our responsibility, we ensure that storage and transport conditions comply with the manufacturer’s requirements.

We retain the information needed to trace devices within the distribution chain. Depending on the product, this includes product reference numbers, batch or lot numbers and/or serial numbers. In the event of a safety notice or recall, we cooperate with the manufacturer, the other parties involved and, where necessary, the competent authorities.

Complaints, non-conformities and incidents

Do you have a complaint or wish to report a non-conformity or suspected incident involving a medical device supplied by us? Please notify us as soon as possible at [email protected].

Where possible, please include:

the product name and reference number;
the UDI and/or batch, lot or serial number, if available;
a detailed description of the complaint, non-conformity or incident;
the purchase or delivery date and your contact details;
any photographs that help illustrate the issue.

We record and assess your report and inform the relevant manufacturer and, where applicable, the authorised representative and importer. Where necessary, we assist with appropriate corrective action.