UDI direct marking
Is it possible to use an "adhesive label" for the direct product marking?
The annex IV of the MDR does not further specify the phrase "permanent and readable".
GS1 states for Direct Part Marking (DPM): The process of marking a symbol directly onto an item using an intrusive or non-intrusive method instead of applying a label or using another indirect marking process.
PRRC
Can the "person responsible for regulatory compliance" (PRRC) be the same for the non-EU manufacturer and his EC-Rep?
According to the MDCG Guidance: No, both need to be independent and are responsible for different tasks.
SOURCE: MDCG 2019-7
SRN
When can manufacturers apply for the Single Registration number (SRN) ?
As per publication of the German DIMDI a generation of the SRN prior to the operational implementation of the EUDAMED isa not forseen.
The single registration number will be assigned automatically by the Eudamed system after your competent authority has registered your adress there.
The registration in Eudamed will be possible on schedule from 26.03.2020.
SOURCE: DIMDI
Declaration of Conformity
Do manufacturers have to ship a Declaration of Conformity with every shipment / product?
1. Regulatory interpretation:
Unlike other European directives or regulations the MDR does NOT require the manufacturer to send a DoC together with every product / shipment.
But for non-EU manufacturers it is required to supply the EU-Representative with the DoC and the subsequent updates (Art. 11, 3 c) .
And the manufacturer is obliged to provide to the competent authorities UPON REQUEST the DoC (translated into that C.A.'s member state official language. ( Art. 19 and ???)
2. Practical aspects:
Sending the DoC along with the other paperwork in the shipment may support custom controls to identify the products are free to enter the EU market.
Further Questions
By the time we will add further FAQ's to this section.
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| Content last updated 2019-10-23 |