A new future for European trade is just around the corner for medical devices

In December 2015, the European Commission announced their negotiations concerning the Comprehensive Economic and Trade Agreement (CETA) to the public. The purpose of this treaty between the European Union and Canada is to strengthen economic relations. This results in an expanding market of medical devices between Europe and Canada. On 15 February 2017 the European Parliament voted in favour with the treaty with a margin of 54 votes. The treaty is expected to be set into motion during the EU-Canada summit on October 27th 2017.

To achieve the purpose of the CETA treaty for medical devices on a sustainable level, existing trade obstructions will be minimized. This means that the CETA treaty will cover custom duties, minimize restrictions on accessing public contracts, standardisation certification procedures,  open-up the services market, offer predictable conditions for investors and help prevent illegal copying of EU innovations and traditional products. The minimizing of these trade regulations could have a great financial impact on all members of the treaty. According to surveys , in 2015 the trade between Canada and the European Union was worth 60 billion Euros. The European Union expects that this will increase with 20 percent which will result in 12 billion Euros growth for the European Union and 8,7 billion Euros for Canada.

Whereas trade regulations and restrictions fade, product safety standards will be maintained. When a medical device is introduced to the European market it has to fulfil the requirements according to the CE certification procedure of the Medical Devices Directive. Vice versa products released on the Canadian market have to be in compliance with the CSA standards. This may seem to undermine scope of the CETA treaty, though in reality a process has begun  for standardization of the procedures. The International Organization for Standardization (ISO) provides both parties with harmonised international standards. Therefore, the product safety requirements in general will be following the same routes. This combined with the CETA treaty gives bright prospects to the future of trading medical devices in Europe and Canada.

For more information regarding the CETA agreement, please contact one of our experts via email (info@ce-mark-medical.com) or via telephone (+31 (0)294 41 75 81).