Amendments to the MDR
On 10 January 2025, a new version of Article 10 of the Medical Device Regulation (MDR) came into force. Paragraph a of this article now introduces a notification requirement for manufacturers. From now on, manufacturers must notify the competent authorities of any interruption or termination of the supply of their products.
We have summarised the main changes for you below. We also refer you to a comprehensive statement by the German Medical Technology Association (download link) on the content and impact of this newly introduced information requirement.
What will Change?
From 10 January 2025, manufacturers will be obliged to report any interruption or termination of the supply of medical devices. Specifically, ‘[...] the competent authority of the Member State [...], as well as economic operators, health institutions and health professionals to whom the device is directly [supplied] [...]’ shall be informed of the expected interruption or termination of supply (EU MDR, Art. 10a, §1).
The period for notification is also specified: six months before the first suspension of delivery, manufacturers are to announce the probable unavailability of their product.
Furthermore, the severity of the consequences of non-arrival for patients is to be announced. Manufacturers will be obliged to provide an assessment of the general health risk posed by the absence of the product based on their own knowledge. However, the expert opinion of the German Medical Technology Association (BVMed) states that relevant harm to public health ‘[...] can only be assumed for certain critical products of particular importance, e.g. life-saving or life-sustaining products [...]’.
In order to record these rather complex changes in a systematic and verifiable manner, the amendment to the MDR also provides for an expansion of the quality management systems (QM systems) of manufacturers. QM systems should reflect and define the processes necessary for compliance with the notification requirement, in particular for the early detection of an interruption or termination of the supply of a device.
What difficulties will manufacturers face?
While this new regulation poses challenges for many manufacturers, its intended goal is clear: to protect patients from the sudden loss of an essential product. It also enables a higher degree of transparency in the medical device market, optimises supply chains and provides legal certainty for both manufacturers and their customers.
However, developing an effective QM system that integrates the new requirements means more work at first. To do this, mechanisms must be implemented that can recognise supply bottlenecks at an early stage, for example. Furthermore, communication channels and a responsible person, according to MDR, should be defined to be responsible for forwarding information.
Furthermore, in practice it is completely open how the responsible authority is to be informed about the upcoming delivery stop and how such a stop is to be recognised in DMIDS, for example.
A strong partner can help manufacturers to meet these new regulatory challenges professionally! BEO BERLIN is familiar with the duties of a Responsible Person as an EU or CH-REP, with creating and optimising QM systems and with communicating between authorities and manufacturers.
If you have any questions about the specific changes to Article 10 of the MDR or if you are interested in our services, please send us an email – BEO BERLIN looks forward to hearing from you!
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