MDR Medical Devices Regulation (EU 2017/745)

What is the MDR?

Deadlines for implementing the MDR

Who is who?

Overview of obligations for distributors

Distributors must make sure, by representative sampling, that the distributed medical devices are compliant with the obligations described in Art. 14 of the Medical Devices Regulation.

Inspection of device and documentation (according to MDR Art. 14 (2))

• The device has been CE marked.
• The EU Declaration of Conformity is available. If the Declaration of Conformity is missing, it is available for download free of charge from the Beurer website.
• Labels and instructions for use have been provided in the official languages of the Member States in which the device is made available (or in languages accepted by those Member States).
• The manufacturer's name has been indicated on the device or in the accompanying documentation.
• NEW! Where applicable, the device has a UDI (during certain transition periods the device may not necessarily have a UDI but is nevertheless classed as a medical device; see the explanation provided under "Unique Device Identifier – UDI").

Assurance of the storage and transport conditions recommended by the manufacturer (according to MDR Art. 14 (3))

• As was already the case for medical devices under the MDD, the storage and transport conditions have been stated on the decorative box and in the instructions for use and must be complied with.

Reporting procedure & documentation (according to MDR Art. 14 (2) – (6))

• If a device is non-compliant with the respective Regulation, then it is prohibited to sell the device.
• Should there be a reason to suspect that a device deviates from this Regulation, the distributor must inform the manufacturer immediately (see the service addresses).
• Distributors must inform the authorities and other economic operators (manufacturers and other distributors in the supply chain) if they suspect that a device has been falsified or that there is a serious risk to health from the device.
• NEW! Distributors must keep a register of complaints, non-conforming devices, recalls and withdrawals.
• Distributors must cooperate with the authorities and make available all the information, documentation and device samples they have at their disposal.
• Distributors must immediately report to the manufacturer any complaints and reports of suspected incidents related to a device that was made available.

The current reporting addresses for Beurer and Sanitas devices can be found on page 11 in the "Downloads and reporting addresses" section

Documentation of the supply chain

Unique Device Identification

How can I identify a medical device?

Which devices from Beurer/ Sanitas are classed as medical devices?

FAQs

Which Beurer devices are affected by the MDR and what are the key deadlines?

Depending on the duration of use, degree of invasiveness and the extent to which the device can be reused, medical devices are categorised into four classes: I, IIa, IIb and III.
Classes Is, Im, Ir, IIa, IIb and III need to be assessed and certified by an appointed body (known as a "Notified Body"). Certificates issued in accordance with the previous MDD continue to apply in line with their specified term or separate regulations/extensions by the Notified Bodies.
Class I devices have so far not required a certificate. They will need to be compliant with the MDR as from 26 May 2021.

As from May 2021 will I still receive all the devices that I previously purchased?

For manufacturers, obtaining the necessary certification for medical devices according to the MDR entails a great deal of time and considerable expense. As a result of this high outlay in terms of time and cost, distributors may find that familiar devices are no longer available.

Beurer has switched over all Class I devices to the MDR in good time.

All selected devices from a higher class will have been switched over to the MDR in good time, by 31 December 2028 at the latest.

Medical devices in accordance with the MDD, with a valid MDD certificate or separate regulations/extensions by the Notified Body, may then be placed on the market until 31 December 2028 at the latest.

We would be glad to help you if you have any further questions about the MDR. Please don't hesitate to contact us at mdr-info@beurer.de

As a distributor, what exactly do I need to document under the MDR?

For a minimum period of 10 years (MDR Art. 10, Section 8), you must document how your devices have been distributed:

• From whom did I purchase the medical device?
• To which other economic operators was the medical device handed over?

NOTE:

The aforementioned obligation to furnish proof ends when the device is handed over to the patient or a private consumer

• If the device is sold in a pharmacy, the pharmacy is not required to record or save the details of the end customer.

The MDR also stipulates this documentation when handing over the device to health institutions (e.g. clinics, doctors' practices or nursing homes). However, at the present time this has not yet been definitively clarified (Art. 25, Section 2c).

Where can I find more information about the MDR?

Downloads and reporting addresses for Beurer and Sanitas