Key Requirements of MDR for Medical Devices
The Medical Device Regulation (MDR) is a new EU regulation that will replace the existing Directive 2007/47/EC on 26 May 2020. The MDR aims to improve patient safety and provide a more robust regulatory framework for medical devices in the European Union. This article highlights the key requirements of the MDR, with an emphasis on areas such as clinical evaluation, risk management, post-market surveillance, and certification.
Clinical Evaluation
One of the most significant changes introduced by the MDR is the requirement for manufacturers to conduct a comprehensive clinical evaluation of their medical devices. The clinical evaluation involves assessing the safety and performance of the device through scientific literature reviews, clinical trials, or other relevant methods. The aim is to demonstrate that the device meets the essential requirements for safety and performance as outlined in Annex I of the MDR.
Here are some key aspects of clinical evaluation under the MDR:
Risk Management: Manufacturers must identify and manage risks associated with their devices through a risk management system.
Clinical Evidence: Clinical evidence is crucial to support the conformity assessment process, including post-market clinical follow-up studies.
Labeling and Instructions for Use: The labeling and instructions for use of medical devices should be based on the results of the clinical evaluation.
Risk Management
Another critical aspect of the MDR is the requirement for manufacturers to establish a risk management system. This involves identifying, assessing, monitoring, and controlling risks associated with their devices throughout their entire lifecycle. The risk management system must be aligned with the ISO 14971 standard on medical devices.
Here are some key aspects of risk management under the MDR:
Risk Identification: Manufacturers should identify potential hazards and risks associated with their devices.
Risk Assessment: A comprehensive assessment should be conducted to determine the likelihood and severity of each identified risk.
Risk Control: Measures must be implemented to mitigate or eliminate identified risks, including design changes, labeling updates, and training programs.
Post-Market Surveillance
The MDR introduces new post-market surveillance requirements for medical devices. Manufacturers are responsible for monitoring their devices throughout their lifecycle to identify any issues that may arise. This includes reporting of incidents, field safety corrective actions, and market withdrawal of products.
Here are some key aspects of post-market surveillance under the MDR:
Incident Reporting: Manufacturers must report serious incidents related to their devices within 15 days.
Field Safety Corrective Actions: Manufacturers should implement corrective actions in response to identified issues with their devices.
Market Withdrawal: Devices may be withdrawn from the market if there is a significant risk to health and safety.
Certification
The MDR introduces new certification requirements for Notified Bodies, which are organizations responsible for assessing conformity of medical devices. Notified Bodies must meet strict criteria, including independence, impartiality, and confidentiality.
Here are some key aspects of certification under the MDR:
Notified Body Requirements: Notified Bodies must comply with Annex VI of the MDR.
Conformity Assessment Procedures: Manufacturers must select an appropriate conformity assessment procedure for their device based on its classification.
Certification Validity Period: Certificates issued by Notified Bodies are valid for 5 years, unless otherwise specified.
QA
This section provides additional details and clarifies some of the key aspects of the MDR.
Q: What is a medical device?
A: A medical device is an instrument, apparatus, appliance, or software intended by its manufacturer to be used on humans for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Q: Who is responsible for ensuring compliance with the MDR?
A: Manufacturers, importers, distributors, and suppliers are all responsible for ensuring compliance with the MDR.
Q: What are the new requirements for clinical evaluation under the MDR?
A: The MDR requires manufacturers to conduct a comprehensive clinical evaluation of their devices, including risk management and post-market surveillance. Clinical evidence is crucial to support the conformity assessment process, including post-market clinical follow-up studies.
Q: Can I use the same documentation for multiple products?
A: No, each product must have its own unique documentation that meets the specific requirements of the MDR.
Q: What are the new requirements for labeling and instructions for use under the MDR?
A: The labeling and instructions for use of medical devices should be based on the results of the clinical evaluation, including information on intended use, risk management, and post-market surveillance.
Q: Who can act as a Notified Body under the MDR?
A: Only independent, impartial, and confidential organizations that meet the criteria outlined in Annex VI of the MDR can act as Notified Bodies.
