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The Corrigendum has been published.

Possibilities for Members States to send comments until Wednesday March 20th end of day.

For MDR, the part in English is at page 38.

For the MDR : https://data.consilium.europa.eu/doc/document/ST-15409-2018-REV-1/en/pdf

To be noticed some significant changes

  • In Annex VII regarding the fact “ that the entire range of devices covered by the certificate is sampled”
  • In Annex IX regarding “by the assessment of technical documentation for devices selected on a representative basis as specified in Section 4.”
  • In Annex IX regarding ‘The notified body shall assess the technical documentation using staff” with deletion of “emploed by”

For IVDR, the part in English is in page 46

For the IVDR: https://data.consilium.europa.eu/doc/document/ST-15418-2018-REV-1/en/pdf

By | 2019-03-19T09:09:59+00:00 March 19th, 2019|news|0 Comments

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