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Review of the EU legislation for 27/01/2025

Two significant EU regulations have been introduced:

1. Medical Devices Joint Scientific Consultations Regulation:

This regulation creates a structured system for scientific consultations on medical devices and in vitro diagnostic devices across the EU. It mandates at least three consultation periods annually and establishes an IT platform for submission of requests. The system involves experts, stakeholders, and patient representatives in the consultation process. Documentation requirements, confidentiality protocols, and data retention periods up to 15 years are specified. The Coordination Group must establish consultation periods for the following year by November 30th.

2. Amendment to Plant Protection Products Regulation:

This regulation modifies the specifications for aqueous extract from germinated seeds of sweet Lupinus albus used in plant protection products. It sets precise technical parameters: BLAD protein content must be 195-210 g/kg, and quinolizidine alkaloids are limited to 0.05 g/kg, with lupanine specifically capped at 0.035 g/kg. The regulation removes the provisional status of technical specifications and includes a grace period of up to 15 months for existing authorizations to comply with new requirements.

Review of each of legal acts published today:

Commission Implementing Regulation (EU) 2025/117 of 24 January 2025 laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices

This Regulation establishes detailed procedural rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices in the EU. It sets up a framework for cooperation between Member States, health technology developers, and expert panels to exchange information and provide guidance on clinical studies and assessments of medical devices.The Regulation’s structure includes provisions on:

  • Setting request periods for joint scientific consultations (at least 3 per year)
  • Submission and handling of consultation requests through an IT platform
  • Selection and involvement of experts, stakeholders and patient representatives
  • Exchange of information between different bodies involved in the consultation process
  • Requirements for documentation and briefing packages
  • Rules for meetings and discussions between parties
  • Personal data processing and confidentiality requirements

Key provisions include:

  • The Coordination Group must set consultation request periods by November 30th each year for the following year
  • Health technology developers can request consultations through a dedicated IT platform using standardized templates
  • Individual experts must sign confidentiality agreements before participating
  • Specific procedures for parallel consultations with expert panels for medical devices
  • Requirements for documentation exchange and meeting organization between all involved parties
  • Personal data retention periods of up to 15 years for consultation participants

Commission Implementing Regulation (EU) 2025/119 of 24 January 2025 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the low-risk active substance aqueous extract from the germinated seeds of sweet Lupinus albus

This Regulation amends the conditions of approval for the low-risk active substance aqueous extract from germinated seeds of sweet Lupinus albus, which is used in plant protection products. The amendment specifically addresses the technical specifications and maximum content levels of certain compounds in the substance.The Regulation establishes specific requirements regarding the purity and content of compounds in the active substance. It sets the BLAD protein content at 195-210 g/kg and establishes maximum levels for quinolizidine alkaloids at 0.05 g/kg, with lupanine as a marker compound set at 0.035 g/kg. The amendment removes the provisional status of the technical specification that was previously in place.Key provisions include:

  • Detailed specifications for the technical material’s composition and purity levels
  • Requirements for Member States to amend or withdraw authorizations for plant protection products containing this substance if they don’t comply with the new specifications
  • A grace period for existing authorizations, which should not exceed 15 months after the regulation’s entry into force
  • Special attention to labeling instructions regarding foaming and stability of dilutions

The regulation maintains strict control over the substance’s composition while ensuring its continued availability as a plant protection product. Member States are required to implement these changes in their authorization processes and ensure compliance with the new specifications.