Why You Need Article 10a Compliance
Legal background
Failure to comply with Article 10a can result in serious regulatory consequences and harm to public health. By managing your obligations effectively, you:
- Protect patient health by avoiding shortages of critical devices.
- Avoid regulatory penalties and maintain market access.
- Build trust with authorities, healthcare professionals, and customers.
- Fulfill legal obligations with timely notifications (six months in advance).
Ensure your Article 10a compliance today.
Both EU-based and non-EU manufacturers must adhere to Article 10a. For non-EU companies, all notifications must go through an EAR such as Obelis. Transparent, timely communication is essential for regulatory trust and continuity of care.
Supply Notification Interruption: How Obelis Supports You
Speak to our experts and avoid regulatory risks. Request a quote from our regulatory experts.
Obelis provides a complete support package to ensure your supply notification interruption is filed accurately and efficiently:
- Preparation & Submission of Article 10a notifications.
- Liaison with Authorities for smooth communication and clarification.
- Regulatory Advice to ensure accurate and complete documentation.
- Continuous Support to help you stay compliant with evolving requirements.
With Obelis, you secure your compliance and ensure an uninterrupted supply of essential medical devices in the EU market.
FAQ
Frequently Asked Questions
An Interruption of Supply Notification is an official communication to the relevant EU authorities indicating a temporary or permanent disruption in the availability of a medical device or product on the EU market. This notification helps ensure transparency, supply chain monitoring, and continued patient safety, especially for critical or high-risk products.
A notification is required under the Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 when a manufacturer becomes aware of a supply disruption, withdrawal, or cessation of a device that is critical for public health or patient care. Timely communication is essential to allow authorities and healthcare systems to take appropriate contingency measures.
The responsibility lies with the manufacturer or their EU Responsible Person (if based outside the EU). For non-EU manufacturers, the notification must be submitted through their authorized EU representative, ensuring that all regulatory obligations are fulfilled accurately and promptly.
Obelis Group, acting as your EU Responsible Person, ensures that all required interruption notifications are submitted to the relevant authorities in line with EU regulations. We provide full support with documentation, communication, and regulatory guidance, helping you stay compliant while maintaining trust with regulators and the market. Our proactive approach minimizes regulatory risks and ensures business continuity.
