Medical Device Regulation (MDR 2017/745)
In 5th April 2017, in response to the EEC requirements (MDR 2017/745) for non-European manufacturers to comply the requirements of this MDR 2017/745 for CE-Mark communications and regulatory need.
CE Mark indicated that the product has is designed and manufactured in accordance with the European Union’s New Approach Regulations and the relevant European Standards. CE Mark ensures free circulation and marketing throughout EU countries. CE Mark is also required for selling products of Non-EU countries in the EU.
“CE” Conformity European is mandatory for a wide range of products sold in the European Union. CE mark certifies that the products have met EU health, safety and environmental requirements that ensure consumer and workplace safety and most importantly your product manufactured as per European Standard.
The Marking should be affixed to one of the following:
• The product itself
• The packaging of the product
• The instructions for use
• The guarantee certificate
