Device notification / registration with competent authority

#1
Can anyone please help me understand the requirements for device notification / registration with the competent authority in EU?

Non EU manufacturer
Class 1 self certified and custom made devices
Appointed EC REP in an EU country, EC REP has registered the Class 1 device with the CA of the country in which EC REP is established.

Question1: Do we need to register the Class 1 device with the CAs of other EU countries to market the product? If yes, who can do that, EC REP or local distributor?
Question 2: What are the conditions for custom made devices ? If registration is required, who can do that, EC REP or local distributor?
 
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chris1price

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#3
You ask about custom made devices - first make sure you meet the definition of a custom made device:

"custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices"


I believe registration of the product is required. MHRA (of course UK is different from EU) clearly indicate this (Register medical devices to place on the market). I can't find the equivalent on EU country sites, but I would expect it to hold true for there as well.
 
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