Medical Device CE Certification Services

⊕  Device Classification

The first step in Medical Device CE Certification is to find out the correct class of the device according to MDR or IVDR rules. Medical devices are divided into different classes such as Class I, Is, Im, IIa, IIb, and III depending on the risk of the device. In the case of IVD devices, they are classified as Class A, B, C, or D. This classification is important because it decides how much regulatory review is needed and whether a Notified Body must check the device before it can be sold.

⊕  Quality Management System (ISO 13485)
Manufacturers must establish a proper Quality Management System (QMS) before applying for CE certification. ISO 13485 is the internationally accepted standard for medical device quality management. The QMS normally includes procedures for design control, risk management, supplier management, complaint handling, and post-market surveillance activities.

⊕  Technical Documentation Preparation
Technical documentation is one of the most important parts of CE certification. The technical file usually contains details such as device description, intended use, design and manufacturing information, risk management documentation, biological evaluation, sterilization validation (if the device is sterile), clinical evaluation, performance data, and labeling with Instructions for Use. For higher-risk devices, this documentation must be reviewed by a Notified Body.

⊕  Clinical Evaluation
Clinical evaluation is an important requirement under MDR. The manufacturer must show that the medical device is safe and works properly for its intended use. This can be done by carrying out clinical investigations, reviewing scientific articles, or comparing the device with a similar device already available in the market. All this information is written and presented in a document called the Clinical Evaluation Report (CER).

⊕  Notified Body Assessment
For most medical devices, except some Class I devices, the documents prepared by the manufacturer must be checked by an independent organization called a Notified Body. The Notified Body will review the technical documents, the Quality Management System, and the clinical evidence to make sure the device follows the required regulations.

⊕  CE Mark Declaration
After preparing the TDF all the meeting regulatory requirements, the CE applicants /manufacturer prepares a document called the Declaration of Conformity (DoC). This document states that the device follows the European regulations. After that, the CE Mark is placed on the device, and the product can then be sold in countries within the European Economic Area (EEA).