CE Mark under MDR (Medical Device Regulation)
Definition
The CE Mark under MDR refers to the certification that a medical device complies with the European Union’s Medical Device Regulation (EU) 2017/745. This mark indicates that the device meets all regulatory requirements regarding safety, performance, and quality before being marketed in the European Economic Area (EEA).
Replacing the previous Medical Device Directive (MDD), the MDR introduces more stringent requirements for clinical evaluation, post-market surveillance, and transparency. Obtaining the MDR CE Mark is mandatory for all medical devices sold in the EU after May 26, 2021.
Detailed Explanation
What is the CE Mark under MDR?
The CE Mark under MDR signifies that a medical device complies with the essential requirements outlined in the EU Medical Device Regulation. It is a legal prerequisite for placing a medical device on the EU market. The MDR CE Mark covers a wide range of devices, from simple bandages to complex implantable devices such as pacemakers.
Key Changes Introduced by MDR
The transition from MDD to MDR brought several significant changes:
- Stricter Clinical Evaluation Requirements: Manufacturers must provide robust clinical data to support the safety and performance of their devices.
- Expanded Scope: MDR includes new categories of products such as cosmetic devices and devices with non-medical purposes (e.g., colored contact lenses).
- Unique Device Identification (UDI): Devices must be traceable throughout the supply chain.
- Post-Market Surveillance: Enhanced requirements for monitoring device performance after it is placed on the market.
- Increased Scrutiny of Notified Bodies: Only designated Notified Bodies can issue MDR CE certifications.
Steps to Achieve MDR Certification
To obtain the MDR CE Mark, manufacturers must undertake a conformity assessment. The process varies based on the classification of the device (Class I, IIa, IIb, or III). The general steps include:
- Determine the risk classification of the device.
- Compile a technical documentation file in accordance with Annex II and III of MDR.
- Conduct a clinical evaluation supported by sufficient clinical data.
- Implement a Quality Management System (QMS), typically ISO 13485 certified.
- Engage a Notified Body for audit and conformity assessment (except for some Class I devices).
- Register the device in EUDAMED (European Database on Medical Devices).
- Affix the CE Mark and issue a Declaration of Conformity.
Clinical Data Requirements
Under MDR, clinical evaluation must be based on clinical data derived from:
- Clinical investigations conducted by the manufacturer.
- Scientific literature and post-market surveillance data.
- Comparable devices, provided equivalence can be demonstrated.
This ensures that the device performs as intended and is safe for its intended use.
Importance of MDR CE Mark
For manufacturers, obtaining the MDR CE Mark is critical for market access in the EU. It also builds trust with healthcare providers and patients, ensuring that the device has met high standards of safety and performance. Additionally, compliance helps avoid legal penalties and product recalls.
Examples of MDR CE Mark Use
- Class I Devices: Surgical gloves, bandages — self-declared compliance with MDR.
- Class IIa Devices: Dental fillings — require Notified Body involvement.
- Class III Devices: Heart valves — require full clinical investigations and extensive Notified Body review.
