CE Marking (Europe) Services in Malaysia

CE Marking (Europe) Services

What is CE Marking?

A CE Mark is a certification mark that indicates a product’s compliance with European Union (EU) safety and environmental requirements. The CE mark is a declaration by the manufacturer that the product meets all the essential requirements of the relevant EU directives or regulations. It allows the product to be legally placed on the market in the European Economic Area (EEA), which includes all the EU member states as well as Iceland, Liechtenstein and Norway.

CE Marking for Medical Devices

If you wish to market your medical device in the European Union, your device will need to be CE marked according to the EU’s regulations on Medical Devices – Regulation (EU) 2017/745, generally referred to as MDR. The MDR took effect on 26th May 2021 and replaced the Medical Device Directives (MDD) (93/42/EEC).

CE marking for medical devices is a way of indicating that the medical device meets the safety and performance requirements of the European Union (EU) and can be sold and marketed legally in the EU.

9 Steps to Obtain CE Marking

Determine the device classification according to the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
Designate a person responsible for regulatory compliance.
Implement a quality management system (QMS) that meets the standards of ISO 13485.
Prepare technical documentation that demonstrates the device’s conformity with the General Safety and Performance Requirements (GSPR).
Appoint an Authorised Representative (EU Rep) in the EU and obtain a Single Registration Number (SRN) from the regulators.
Choose a suitable conformity assessment route and for all risk class except class I (non-sterile, no measuring function), obtain certification from a Notified Body (NB).
Register the device with EUDAMED.
Issue a Declaration of Conformity.
Affix the CE mark.

Malaysia Consulting Service for CE Marking

Searching for a Professional Medical Device Consultant?

We understand the challenges of producing documentation for regulatory compliance. Let our team assist you with the preparatory work and the appointment of a EU representative and help ensure your device is registered with the appropriate regulatory authority.