Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
How to obtain CE marking?
As the product’s manufacturer, you bear sole responsibility for declaring conformity with all requirements. You don’t need a license to affix the CE marking to your product, however, before doing so, you must:
- ensure conformity with all relevant EU-wide requirements
- determine whether you can assess your product by yourself or if you have to involve a notified body
- put together a technical dossier documenting conformity: find out about technical documentation
- draft and sign an EU declaration of conformity
Once your product bears the CE marking — if the competent national authority requests — you must provide them with all the information and supporting documentation concerning CE marking.
More information: on CE marking on the website of the European Commission
How about Medical Devices?
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments.
The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science and progress in law-making.
Date of application of the Medical Devices Regulation postponed until May 2021.
On 26 May 2021, the Medical Device Regulation will become fully applicable, following the transition period. Please keep the revised deadline firmly in mind.
Interested to learn more:
° Access the text of the regulation
° Information on the website of the European Commission: here