Preparing for Europe’s New In Vitro Diagnostic Medical Device Regulation

European Database for Medical Devices (EUDAMED)

As part of the new IVDR, the European Commission developed a secure database called EUDAMED to improve transparency and coordination of information regarding medical devices on the EU market.

The system is comprised of six modules:

1. Actor Registration: Enables economic operators (i.e., manufacturers, authorized representatives, and importers) to register their information
2. Unique Device Identification (UDI): Maintains device-specific information. Economic operators are responsible for managing all UDI attributes and transferring the data to EUDAMED
3. Certificates: Maintains EU certificates for each product group
4. Clinical Investigation: Maintains information regarding the collection and analysis of clinical data
5. Vigilance: Maintains serious incident reports
6. Market Surveillance: Maintains post-market surveillance reports

The Actor Registration module went live on December 1, 2020. Economic operators are encouraged to register with the system and obtain a single registration number (SRN) to meet the requirements of the regulations. The operation of all six modules is necessary for full IVDR implementation and is scheduled for May 2022.

Serious Incident and Corrective Action Reporting

Under the new regulation, manufacturers will need to report all serious incidents and field safety corrective actions to competent authorities via the EUDAMED database.

Serious incidents must be reported within these timeframes:

• Immediately, but no later than 2 days post incident if it represents a serious threat to public health
• Immediately, but no later than 10 days post incident if it involves a death
• Immediately, but no later than 15 days post incident if it has little to no consequence to patient or user (*Note: The reporting period was 30 days under previous regulations)

If necessary, a partial report can be submitted initially to meet these deadlines. Field safety corrective actions must be reported to a competent authority before implementation, unless the safety of the patient is at risk and the corrective action needs to be taken immediately.

Arena QMS Tip:
Quality Templates

Leverage the Arena quality templates to prepare your serious incident and field safety corrective action reports. Once created, they are linked to your product record and show the history of any changes that are made. Documents can be easily exported and included with your technical file.