CE European Conformity Tests in Medical Devices

In April 2017, a legal regulation numbered 2017/745, valid in European Union countries, for clinical research and sales of medical devices was published. In this regulation, a gradual transition process was determined for originally approved medical devices to meet the new requirements. Accordingly, the new medical devices regulation (MDR) came into force in 2021, and the in vitro medical diagnostic devices regulation (IVDR) will come into force in 2022.

Broadly, the updated medical devices regulation (MDR) aims to improve the quality and safety of medical devices, make the data used for approvals more transparent, improve post-marketing surveillance, and reduce administrative burdens on manufacturers by tightening how they are evaluated and documented before they are placed on the market.

In order to market a medical device in the European Union countries, the product must bear the CE mark. The CE Mark shows that this medical device complies with the current European Union legal regulations and allows these products to be marketed in all European Union member states. A medical device manufacturing company is responsible for ensuring regulatory compliance and securing the CE marking for the product, regardless of whether it outsources any or all components of its manufacturing operation. Likewise, companies producing in vitro medical diagnostic devices must meet similar requirements for CE marking.

The CE mark is not a quality mark, compliance with the medical devices regulation 2017/745 requires meeting certain performance, quality, safety and efficacy standards for the product type. In general, the process should follow these steps:

• Determine if the product meets the medical device definition according to the MDR
• Determine the classification of the device
• Prepare CE marking technical file
• Prepare a clinical assessment report according to the MDR
• To appoint a representative within the European Union
• Requesting inspection from a notified body if the device is not class I
• ConfirmationObtaining CE mark certificate from the notified body
• Issue a declaration of conformity stating that the device complies with the MDR

Our organization also provides CE European conformity testing services for medical devices, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.