La fijación del tiempo en el cual debe señalarse la audiencia única en el procedimiento monitorio y su incidencia frente al retardo injustificado.

If certification of devices under the MDR has not been finalised before expiry of the Directive’s certificate, and where the device does not present an unacceptable risk to health

In addition to the requirements set out in Chapter VII MDR, also other MDR requirements should apply to ‘legacy devices’, provided that those requirements

The notified body that issued the AIMDD or MDD certificate may confirm in writing (after having reviewed manufacturer’s description of the (proposed) change) that the

Cedulario se inicia a mediados del siglo XVIL, por sus propias cédulas puede advertirse que no estaba totalmente conquistada la Nueva Gali- cia, ya que a fines del siglo xvn y en

que hasta que llegue el tiempo en que su regia planta ; | pise el hispano suelo... que hasta que el

The 'On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services' document must be considered the reference guidance, as this document includes the

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in

This section provides guidance with examples on encoding medicinal product packaging information, together with the relationship between Pack Size, Package Item (container)