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The European Commission talks
The European Commission has posted brand new guidelines in Q&A structure for getting CE Mark official certification and putting commercial items including medical products regarding the European market in the eventuality of a no-deal Brexit.
On January22, 2018 the Commission that is european published Notice to Stakeholders about the withdrawal associated with the British through the European Union (EU) (i.e., Brexit). The notice explained that Brexit will have a significant effect on use of medical products manufactured, imported and/or certified in britain towards the Single marketplace. Recently, on February 1, 2019 the European Commission has granted a Q&A document about the official certification and placing in the marketplace of commercial items. This document is relevant if a no-deal Brexit situation comes to pass through, in which particular case you will have no (transformation) arrangements.
The thought of â€œplacing available on the marketâ€
You should completely understand what exactly is meant by â€œplacing available on the marketâ€ to be able to know very well what items is lawfully used and distributed into the EU after Brexit. First, you should realize that this idea means each product that is individual not to ever forms of services and products. Which means two shipments of identical items will each individually be considered.
The 2nd crucial point is about ownership. If an item happens to be offered, the area of this brand new owner will see whether the item happens to be added to the EU market. Leggi tutto “European Commission needs for Marketing Medical Devices in a No-deal Brexit Scenario”