Medical Devices Joint Scientific Consultations Regulation
The regulation creates a structured EU-wide system for scientific consultations on medical devices and in vitro diagnostic devices. It requires at least three annual consultation periods and establishes an IT platform for submissions. Key elements include:
- Coordination Group must set consultation periods by November 30th for following year
- Standardized templates and procedures for consultation requests
- Involvement of experts, stakeholders and patient representatives
- Strict confidentiality protocols
- Data retention periods up to 15 years
- Detailed documentation requirements
Plant Protection Products Amendment
The regulation updates specifications for aqueous extract from germinated sweet Lupinus albus seeds used in plant protection. Key technical parameters:
- BLAD protein content must be 195-210 g/kg
- Total quinolizidine alkaloids limited to 0.05 g/kg
- Lupanine specifically capped at 0.035 g/kg
- Removes provisional status of specifications
- 15-month grace period for existing authorizations to comply
