Glossary
MEDDEV 2.12
What is MEDDEV 2.12?
MEDDEV 2.12 is a set of guidelines within the European Union’s regulatory framework for medical devices, focusing specifically on post-market surveillance and vigilance. It provides comprehensive instructions for manufacturers on monitoring the performance of medical devices after they have been released to the market, reporting incidents and adverse events, and ensuring continuous improvement of device safety and performance. These guidelines are essential for maintaining compliance with the Medical Devices Directive (93/42/EEC) and the In Vitro Diagnostic Devices Directive (98/79/EC).
What are the critical responsibilities of MEDDEV 2.12?
It outlines the obligations of EU member states to report and investigate incidents and the reporting requirements for manufacturers. It includes reporting any malfunction, deterioration, or inadequacy in a device that could lead to death or serious deterioration in health.
It provides guidelines on the timelines for reporting serious incidents. Reports are required within 15 days for serious incidents, ten days for incidents leading to death or serious deterioration, and two days for public health threats.
It covers the requirements for manufacturers to implement field safety corrective actions for devices on the EU market that are affected by a safety risk, and to notify the competent authorities.
How does MEDDEV 2.12 ensure regulatory compliance?
MEDDEV 2.12 ensures regulatory compliance by providing structured guidance on the following:
- Post-Market Surveillance (PMS): It mandates that manufacturers implement a PMS system to systematically collect and analyse data on device performance, identifying potential issues early.
- Incident Reporting: It outlines specific procedures and timelines for reporting incidents and adverse events to the relevant authorities, ensuring timely regulatory response.
- Risk Management Integration: It ensures that PMS activities are integrated with the manufacturer’s risk management processes, facilitating ongoing compliance with safety standards and regulatory requirements.
