New information obligations for medical device manufacturers according to Art. 10a MDR / IVDR
The Amending Regulation (EU) 2024/1860 of 13 June 2024 has been in force since 10 January 2025. With it, the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746) have received an identical Art. 10a.
Art. 10a requires manufacturers of medical devices and manufacturers of in vitro diagnostic medical devices (class A to D devices, as well as legacy devices) to notify the competent authority in the member state in which the manufacturer or its authorised representative is established in the event of foreseeable supply interruptions or termination of the supply of one of their products. The manufacturer must also inform economic operators, healthcare institutions and healthcare professionals to whom it supplies the product directly. The notification must be submitted electronically in machine-readable form using a form provided by the competent higher federal authority on its website no later than 6 months before the occurrence of the event triggering the notification (cf. Section 7a of the MPDG).
The obligation to notify unavailability is subject to two cumulative requirements:
- Any unavailability must cause either serious damage to the patient’s health, a significant deterioration in the pathological condition or a risk of death. The judgement was based on a reasonable discretionary decision in which only circumstances already known to the manufacturer should be taken into account.
- There is no comparably suitable treatment alternative on the market for affected patients and treating physicians.
Practical tips and recommendations for action
Knowledge of the existence and content of Art. 10a is the key to complying with any duty to inform. It is advisable to create an internal matrix for eligible products based on the requirements of Art. 10a, the required form and the economic operators to be informed:
- Monitoring of (non-)availability in the next 6 months.
- Does unavailability lead to serious disadvantages?
- Are there equivalent treatment options on the market?
Art. 10a is in the light of traditional European consumer protection and is linked to the values of the NIS2 Directive transposed into national law in October 2024. The healthcare industry is critical infrastructure and medical device manufacturers are essential or important facilities. The aim of the amendment is to improve planning by the responsible authorities and stakeholders in the healthcare sector in order to avoid supply shortages. Almost four years of the pandemic have highlighted the susceptibility and vulnerability of supply chains and the resulting availability of necessary medical devices and in vitro diagnostics. It remains to be seen whether this requires a reporting obligation subject to fines or whether the established best practice approach was sufficient. The scope of application is narrow due to the requirements of Art. 10a of the MDR/IVDR. The number of notifications will probably be just as manageable.
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