En esta reunión se ha revisado el borrador final de las especificaciones comunes de obligada aplicación para productos de anexo XVI que se espera sean publicadas a primeros de 2022, entrando pues en aplicación en verano 2022 (a los 6 meses de su publicación). Ya veremos si se publica antes dado su avance.
Se publicará como Reglamento de ejecución con este indice:
Article 1 Scope and subject matter
Article 2 Transitional provisions
Article 3 Entry into force and date of application
ANNEX I applies to all the devices covered by Annexes II to VII. Risk Management General Requirements
ANNEX II applies to contact lenses listed in Section 1 of Annex XVI.Specific risks. Information for safety
ANNEX III applies to products listed in Section 2 of Annex XVI.Specific risks. Information for safety
ANNEX IV applies to products listed in Section 3 of Annex XVI.Specific risks. Information for safety
ANNEX V applies to products listed in Section 4 of Annex XVI.Specific risks. Information for safety
ANNEX VI applies to products listed in Section 5 of Annex XVI.Specific risks. Information for safety
ANNEX VII applies to products listed in Section 6 of Annex XVI.Specific risks. Information for safety
Seguiremos informando