Interested in The Medical Device Regulations? Read more about Obelis webinars on it.
News
MDR Seminar: Updates & Implementation
Updates & Implementation on Medical Devices Regulations
MDR WEBINAR – UPDATES & IMPLEMENTATION
Are you interested in the Medical Devices Regulations? Check out our webinars on these topics.
Finnish Medicines Agency Takes Over Medical Device Regulation
Fimea, the Finnish Medicines Agency, took over the supervision of medical devices, operators and device trials from Finland’s National Supervisory Authority for Welfare and Health (Valvira).
IFRA Standards – 49th Amendment
In the light of the major changes, the transitional compliance period has been exceptionally prolonged after the notification date, i.e. January 10, 2020.
Parallel trade under the MDR
Parallel imports under the MDR, when, who and how:
EUDAMED POSTPONED, CONSEQUENCES FOR COMPLIANCE?
So which actions do Manufacturers have to take to be MDR COMPLIANT for the EU market?
Read more about it here.
SWEXIT OR NEW MRA?
If a “worst-case scenario” was actually to happen, Swiss manufacturers will have to meet third country requirements.
What is the difference between Safety Testing and Safety Assessment?
safety test, safety assessment, cosmetics, cosmetic industry, cosmetic compliance, ensure cosmetic compliance, safety of the cosmetic product
Incidents with medical devices: novelties
If you wish to have more information about the new Nomenclature, Obelis Experts will assist you in ensuring compliance of your IVD medical devices.