The European Union comprises 28 countries that require CE Marking. Three additional countries (Norway, Iceland, Liechtenstein), although not officially part of the European Union, are signatories to the European Economic Area (EEA). Switzerland is not an EU member nor a signatory to the EEA, but they have transposed the Medical Devices Directives into their national law and these countries require CE Marking.
We can assist you in obtaining CE Marking so you can sell your medical device in any of these European countries.
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read moreIVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a t
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