Aspectos jurídicos de la estrategia sanitaria de la seguridad de los pacientes

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

Where possible, the EU IG and more specifically the data fields and associated business rules present in Chapter 2 –Data elements for the electronic submission of information

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

In medicinal products containing more than one manufactured item (e.g., contraceptive having different strengths and fixed dose combination as part of the same medicinal

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)