Submission Guidelines for EU Reference Laboratory Applications

Laboratories in Spain seeking designation as European Union Reference Laboratories for in vitro diagnostic medical devices must follow the application process outlined in Regulation (EU) 2017/746. This document provides updated guidelines for the second call for designation, managed by the Spanish Agency for Medicines and Medical Devices (AEMPS).

Application Process

• Regulatory Basis – Applications must comply with Article 100 of Regulation (EU) 2017/746.
• Submission Phases – The process includes validation, verification, and final designation.
• Role of AEMPS – The agency assesses preliminary documentation and ensures compliance with EU criteria.

Key Updates in This Version

• New deadlines for submission and publication dates.
• Additional guidance for consortium members.
• Expanded legislative references for clarity.
• More detailed documentation requirements compared to previous versions.

Required Documentation

Laboratories must submit:

• Certification & Compliance – Proof of regulatory adherence.
• Personnel & Equipment Details – Staffing qualifications and laboratory infrastructure.
• Reference Materials & Standards – Use of internationally recognized standards.
• Administrative & Financial Reports – Organizational and funding structure.
• Confidentiality Policies – Data protection and security measures.
• Externalization of Tests – Policies on outsourcing testing activities.

This designation process ensures that selected laboratories meet the highest standards for testing and verification of in vitro diagnostic medical devices in the European Union.

Source: https://www.aemps.gob.es/investigacionClinica/medicamentos/Instrucciones-laboratorios-referencia.pdf
Region: Europe