MDR Delay!

2020.04.24 In writing and set in stone with the publication on the Official Journal of the European Union. Here is the publication. 2020.04.20 On Frid...

Notified body number 11!

The notified body (NB) designation is moving along. Congratulation to NSAI. We have to note the scope NSAI shows as one of the smaller notified bodies...

For risk class I manufacturer!

  Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to t...

Second Corrigendum to the MDR and IVDR

This update gives certain Class I manufacturer a break. On December 27 the second corrigendum was published in the official Journal of the EU. This up...

MDR Transition!

Plan with your EC REP to get your products ready to market by May 2020. The deadline is approaching quickly and EC REPs resources need to be allocate...

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