Interested in The Medical Device Regulations? Read more about Obelis webinars on it.
News
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.
The European Medical Device Nomenclature (EMDN): Background and Generalities
The CND classifies medical devices in three different levels – Category (first level), Group (second level) and Type (third level) – following an alphanumeric structure.
New amendments brought by Regulation 2019/1966 on CMR Omnibus
Read more about the New amendments brought by Regulation 2019/1966 on CMR Omnibus