To sell in the European Union, manufacturers must have and keep up-to-date the technical documentation for their medical devices. This applies to all manufacturers of medical devices and IVD medical devices, whether based in the EU or not.
The technical documentation has to include all elements relevant for the device set out in the Medical Devices and IVD Medical Devices Regulations (MDR and IVDR) to demonstrate conformity with the applicable Regulations. A compliant technical file is a key aspect when aiming to obtain the CE marking for the European markets.
Our solution
Interruption of supply notification
Article 10a of the MDR and IVDR requires manufacturers to notify EU authorities of significant supply interruptions or discontinuations of medical devices. This ensures their continued availability to protect public health.
Non-EU manufacturers can rely on its authorised representative to inform the competent authority of supply issues.
As your European Authorised Representative (EAR), Obelis will manage the notification process, liaise with authorities, and provide them with the required documentation to ensure compliance with Article 10a.
Good to know
About Article 10a
Article 10a of the Medical Devices Regulation (MDR) and In-Vitro Medical Device Regulation (IVDR) establishes the obligation for manufacturers to notify the competent authorities of any significant supply interruption or discontinuation of medical devices that could seriously compromise patient health or public health. This notification to the authorities should be performed at least 6 months before the projected discontinuation or interruption takes place.
Manufacturers of medical devices and IVDs circulating on the EU market are primarily responsible for complying with Article 10a. Non-EU manufacturers should submit the relevant notification to the Competent Authority where their EAR is based.
Additionally, manufacturers should communicate the supply issue to the entities to which they directly supplied the device, e.g., importers, healthcare professionals. These notified entities are obliged to ensure downstream information flow to reach healthcare professionals.
Comply with Article 10a today
If you need to notify under Article 10a, Obelis will:
- Prepare and submit the Article 10a notification to the competent authority.
- Liaise with the competent authority to ensure a comprehensive understanding of the supply interruption or discontinuation.
- Assist in providing additional documentation or clarifications requested by the authority.
- Advice on regulatory compliance issues.
Over 35 years of Obelis expertise ensures that your company meets the requirements of Article 10a promptly and efficiently, safeguarding the availability of essential medical devices in the EU market.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
