The Swiss medtech market is now served by 1,200 companies fewer than when its MRA with the EU was still in force. A renewal of the agreement is not a lost hope for the local industry, but at present it is a distant prospect.
For all the sense of anticipation about US Food and Drug Administration-approved products possibly being used in a European patient population for the first time, the Swiss medtech industry and market have one overriding priority: to work closely with the EU regulatory system and perhaps one day re-establish the mutual recognition agreement (MRA) with the EU.
The MRA effectively came to an end for the respective Swiss and EU medtech industries on 26 May 2021, after...
Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
