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Combination products - examples

#1
Dear readers,

combination products are defined in MDR Article 1 (8) and MDR Article 1(9).

products within the second sub-paragraph of Article 1(8) are combination prodcuts that will be regulated as medicines. See article below

Article 8:

"Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation.

2n paragraph -->"However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 1 ), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned "

Can someone provide me an example of these types of combination products? I haven't been able to find any example!!!

Thanks in advance!
 
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