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EC Clarifies Status of Expert Panels
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to...
MHRA Guidance about No-Deal Brexit
British medical products regulating authority, the MHRA, issued a special guidance describing the impact Brexit could have on medical device regulations. The guidance describes the consequences of Brexit to all parties...
DKMA Consultations on MDR
Danish Medicines Agency (DKMA) announced that they would provide special consultation on the requirements set forth by Medical Device Regulation (MDR 745/2017). These consultations are intended for small and medium...
CE Certificate Renewal Deadline is Approaching
  All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses. CE Certificate...
EU Medical Device Regulations
The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical...
AEMPS Applies for NB Designation
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device...