Conformity Assessment Procedure as per EU MDR 2017/745

  • As we know, medical device products distributed within Europe must comply with the new European Medical Device Regulation (MDR) by 2020 and its replace existing Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD).
  • As per MDR Article 51 and Annex VIII your product will classified in the four categories as per the product’s intended use. The four categories are Class I, IIa, IIb, III. As per MDR article 52 you can found which conformity assessment procedure applicable to your product as per their classification. There are Annex IX, X and XI of MDR which define conformity assessment procedure.

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