Medical devices and healthcare auto

Updates from the Medicines and Healthcare Products Regulatory Agency on the withdrawal of several UK-based notified bodies.

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.

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 imports under the MDR, when, who and how:

If a “worst-case scenario” was actually to happen, Swiss manufacturers will have to meet third country requirements.

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 CND classifies medical devices in three different levels – Category (first level), Group (second level) and Type (third level) – following an alphanumeric structure.