(An implementing act clarifies the "how" to implement)
(A delegating act clarifies the "what" needs to be further specified)
The entire LIST OF GUIDANCE DOCUMENTS published by the European Commission can be found on the "DOCS ROOM".
The MDR introduced a lot of changes, the most important are:
The EU-Commission plans to use the Italian CND for the technical coding of medical devices for entry into the EUDAMED database as well as for further aspects e.g. for the sampling of the technical documentation.
The CND nomenclature will be further aligned with the existing GMDN nomenclature in order to reach further harmonization.
The European Unique device identifier (UDI )composes of two visible parts:
and one non-visible part:
The B-UDI-DI is never used on the labelling
The B-UDI-DI is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics and is used for reference in:
2021-05-26 (UDI Carrier on label) and
2023-05-26 (Direct marking for reusables)
2023-05-26 (UDI Carrier on label) and
2025-05-26 (Direct marking for reusables)
2025-05-26 (UDI Carrier on label) and
2027-05-26 (Direct marking for reusables)
For the so called "legacy devices" (Devices being certified by a notified body under the MDD) you may make use of the prolonged transition (sometimes called "grace period") time which is depending on the validity of the existing MDD certificate and will end on 2024-05-26.
The only condition is your "legacy products" are not subject to a change.
If you intend to change the "legacy product" you may have to apply the MDR, depending on the kind of change.
For further information please CONTACT us.
|Content of this website was last updated 2019-10-22|
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