medical device ce marking

MDR or IVDR CE Marking Service

Medical Device CE Marking is a mark that shows the medical devices in compliance with medical device regulation and General safety and performance requirements as per the EU commission.

CE Marking of Medical Devices as per MDR 2017/745

Medical Device EU MDR Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 are the two new regulation.

CE Marking logo affixed on the medical device indicates the device fulfills the quality requirements and harmonized standards.

It is the responsibility of the Medical Device manufacturers or distributors to make sure the device sold in the above countries must comply with the Medical Device Regulation (MDR) before affixing CE Marking and placing them on the European Market.

Failure to do so can result in sanctions such as removal of products from sale or use and in some cases prosecution.

MDR 2017/745 PDF File Download >>

CE Marking Process Flow >>

CE Marking of In Vitro Diagnostic Devices as per IVDR 2017/746

All IVD OEM manufacturers of class A, B, C, and D devices will need to provide Technical documentation, Clinical performance Data, Performance Evaluation Report to Notified Body in order to obtain CE Marking.

Class A device's technical documentation will not be reviewed by a Notified Body.

Clinical performance data is required for classes B, C, and D and the requirements are more complex than they are for most medical devices.

This will help NB to build confidence that the manufacturer makes a medical decision related to indications for use established for the device.

Performance Evaluation Report is new to the In Vitro Diagnostic Devices and is similar to the Medical Device CER. Performance Evaluation Report includes a collection of data that forms major share in the overall technical documentation.

The PER requirements are described in chapter VI, Article 56 and Annex VIII, Part A (1.3.2). Performance Evaluation Report for Class A and B devices can be updated as needed based on the residual risk-benefit.

In Vitro Diagnostic Regulation (IVDR 2017/746) will be effective from May 25, 2017. This will replace in-vitro diagnostic medical devices (IVDD 98/79/EC).

The IVDR stipulates more requirements for CE marking. OEM manufactures must plan, prepare and implement strategies for adhering to new requirements in the coming 2 years.

As regulatory consultants, our team is adequately trained in core areas of technical documentation and performance evaluation reports and can help in the transition to the new regulation.

We provide complete solutions and can offer one-stop solutions for CE Marking requirements.

IVDR 2017/746 PDF File Download >>

More about Consultants Role in CE Marking >>

Recent Client Testimonial.

Review commented by Sam James in . Wonderful Team!!!. They are very good. I am glad to recommend I 3 CONSULTING to others looking for CE Marking support. Rating: 4.9