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).
Medical devices and healthcare auto
Catch a glimpse of proposed symbology under the MDR!
Manufacturers are encouraged to use the following symbols, if needed for particular cases, always in the same order as shown below – with the aim to speed up user recognition and acceptance of the symbols and their meaning.
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.
Clinical investigation of medical devices for human subjects
“ISO/DIS 14155 – Clinical investigation of medical devices for human subjects — Good clinical practice” is currently under preparation for its final publication and will replace the second edition of the standard ISO 14155:2011. Read more about it
Spanish Agency on labelling medical devices in case of Brexit
Advice and guidance from the Spanish regulatory experts on how to handle medical device labelling under Brexit. Assigning an EAR, notification, and more.
The European Commission has published a FAQ document on UDI
Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain. Read more about it here.