Swiss manufacturers have one year’s respite after the European Union decided to postpone new rules on approval of medical equipment.
The move had been urged by European Union manufacturers because of low capacity to accredit under the new rules and problems the industry is facing due to coronavirus. The EU Commission agreed to postpone the deadline to May 26, 2021, and this was approved by the EU parliament on Friday.
The new rules had been due to enter force on May 26 this year. Swiss manufacturers would have had not only to comply with the new rules but also prepare to lose privileged access to the EU internal market as a result of the stalled negotiations between Bern and Brussels on a new “framework agreement”. The EU has made it clear on several occasions that existing bilateral agreements with Switzerland would not be renewed without such an overall framework deal. One of the first victims would have been the Mutual Recognition Agreement (MRA) on conformity of medical technology.
The Swiss Medtech organization representing the industry in Switzerland welcomed the move. It recommended that its members "use the next 12 months to prepare in an optimal way for the eventuality that the MRA is not renewed in a year", according to spokesperson Anita Holler, whilst at the same time urging the Swiss government to “work at all levels using all its possibilities to get a rapid renewal of this agreement”.
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