European Union Market
MDR and IVD Compliance
Medical Device
IVD
ENQUIRE NOW
What are MDR and IVD Compliance?
MDR Compliance is a service designed to help medical device manufacturers comply with the requirements set forth by the European Union's Medical Device Regulation (MDR). This service involves a comprehensive evaluation of the manufacturer's products to determine if they meet the new requirements set forth by the MDR. The service also includes assistance with the development of technical documentation, risk management, and post-market surveillance.
Why are MDR and IVD Compliance important?
Assurance
MDR Compliance is critical for medical device manufacturers who want to continue marketing their products in the European Union.
Patient Safety
Compliance also helps to ensure that medical devices meet the highest safety and quality standards, which ultimately benefits patients and healthcare professionals.
Compliance
By partnering with a regulatory consulting firm for MDR Compliance, manufacturers can streamline the compliance process and mitigate the risks associated with non-compliance.
Market Access
Non-compliance with MDR regulations can result in the removal of products from the market, legal action, and damage to a manufacturer’s reputation.
Process Flow for MDR and IVD Compliance
Classify Your Medical Device: Determine the appropriate classification of your medical device according to the MDR.
Conformity Assessment Procedure: Select the appropriate conformity assessment procedure based on the device classification. This may involve self-assessment or involvement of a notified body for higher-risk devices.
Prepare Technical Documentation: Develop comprehensive technical documentation that demonstrates compliance with the MDR requirements. This documentation should include device descriptions, manufacturing processes, risk assessments, clinical data, and post-market surveillance plans.
Perform Clinical Evaluation: Conduct a thorough clinical evaluation of your device to demonstrate its safety and performance.
Implement Quality Management System: Establish a quality management system (QMS) that conforms to the MDR requirements.
Appoint Authorized Representative: If you are a non-EU manufacturer, designate an authorized representative based in the EU to act on your behalf for regulatory compliance and communication with authorities.
Compile Technical File and Declaration of Conformity: Assemble the technical file, which includes all relevant documentation and evidence of conformity.
Affix CE Marking: Once you have completed the necessary steps and your device is compliant with the MDR, affix the CE marking on your device, packaging, or accompanying materials..
Post-Market Obligations: Fulfill post-market obligations, such as vigilance reporting, post-market surveillance, and ensuring ongoing compliance with the MDR.
How can we help in MDR and IVD Compliance?
The CliniExperts professionals will -
Help in preparing comprehensive technical documentation that demonstrates compliance with the MDR requirements.
Help in reviewing existing clinical data, performing clinical investigations if necessary, and documenting the results.
Assist you in implement Quality Management System which includes processes for risk management, post-market surveillance, complaint handling, and quality control during manufacturing.
Assist you in assessment procedures which include conformity assessment modules.
Regulatory requirements for MDR and IVD Compliance
Timeline
The timeline for MDR compliance varies depending on the classification of the medical device and whether it requires the involvement of a notified body.
Regulatory Body
The regulatory body responsible for overseeing MDR compliance in the EU is the European Commission. The European Commission is supported by the Medical Device Coordination Group (MDCG), which provides guidance and recommendations to ensure consistent implementation and application of the MDR across the EU member states.
Fees
Fees associated with MDR compliance can vary depending on several factors, such as the involvement of notified bodies, conformity assessment procedures, and the classification of the medical device. Notified bodies may charge fees for their services, including conformity assessment and certification.
Validity
MDR compliance is an ongoing requirement for medical device manufacturers. Once a device has obtained MDR compliance, it does not have a specific validity period. However, manufacturers must continue to ensure ongoing compliance with the MDR requirements throughout the lifecycle of the device.
