Europe adopts new measures to respond to COVID-19 outbreak, including measures to speed up MD & IVD device EU market introduction and free info on EU standards.
Medical devices and healthcare
Withdrawal of notified body services: MHRA takes over
Updates from the Medicines and Healthcare Products Regulatory Agency on the withdrawal of several UK-based notified bodies.
Joint implementation plan on the new Medical Devices Regulation – (EU) 2017/745 (MDR)
With the 26 of May around the corner, and as response to the call from the Council of the EU (EPSCO), the MDCG (Medical Device Coordination Group) has issued a document stating the challenging joint responsibility Member States and the Commission have, together with the concerned stakeholders, to ensure that the new legislation on medical devices is operational from the aforesaid date.
Important Notice: COVID-19 (coronavirus)
In light of the rapid spread of COVID-19 (coronavirus) in Belgium, Obelis has implemented on March 2020, teleworking in order to minimize the potential health risk to our personnel. To ensure a smooth and efficient service, we kindly request you to schedule in advance any request for a conference call.
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).
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.
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.