United Kingdom Market
MDR and IVDR Compliance
Medical Device
IVD
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What are MDR and IVDR Compliance?
In the context of medical devices, compliance with the Medical Device Regulation (MDR) & In-Vitro diagnostic Regulation is necessary for obtaining CE Marking. The CE Marking service for medical devices involves the assessment and evaluation of the device's conformity with the requirements of the UK MDR & IVDR.
Why are MDR and IVDR Compliance important?
Compliance
Manufacturers must stay informed about regulatory updates, implement necessary changes, and demonstrate compliance to navigate the regulatory landscape effectively.
Patient Safety
MDR and IVDR compliance is essential in the UK market to meet legal requirements, ensure patient safety, gain market access, and maintain a competitive edge.
Process Flow for MDR and IVDR Compliance
Understand MDR and IVDR Requirements: Familiarize yourself with the specific requirements outlined in MDR and IVDR that apply to your medical devices or in vitro diagnostic medical devices.
Conduct a Gap Analysis: Collaborate with regulatory experts or consultants to conduct a comprehensive gap analysis of your existing processes, documentation, and quality management system.
Update Technical Documentation: Review and update your technical documentation to meet the requirements of MDR and IVDR.
Perform Clinical Evaluations: Ensure that your devices have undergone appropriate clinical evaluations as per the requirements of MDR and IVDR.
Implement Quality Management System (QMS) Changes: Evaluate your existing QMS and implement necessary changes to align with the stricter requirements of MDR and IVDR.
Engage Notified Body: Engage with a notified body accredited for MDR and IVDR certifications.
Post-Market Surveillance: Establish robust post-market surveillance procedures to monitor the performance, safety, and quality of your devices in the market.
Labeling and UDI Compliance: Ensure that your labeling complies with MDR and IVDR requirements, including the new Unique Device Identification (UDI) system.
Stay Informed and Updated: Continuously monitor regulatory updates and changes related to MDR and IVDR.
How can we help in MDR and IVDR Compliance?
The CliniExperts professionals will -
Review and update your technical documentation.
Identify areas that need improvement or alignment with MDR and IVDR requirements.
Help is updating procedures, work instructions, and quality manuals to meet the enhanced quality and risk management expectations.
Help in obtaining the necessary certifications or conformity assessments required for market entry.
Regulatory requirements for MDR and IVDR Compliance
Timeline
May 26, 2024 is the end of the transitional period for MDR and IVDR compliance. By this date, all medical devices and in-vitro diagnostics placed on the UK market must comply with the UK MDR and UK IVDR requirements respectively.
Regulatory Body
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation and oversight of medical devices and IVDs.
Fees
Fees associated with MDR and IVDR compliance in the UK may vary depending on the type and classification of the medical device. The MHRA publishes fee schedules outlining the costs associated with different regulatory activities, such as device registration, conformity assessments, and notifications.
Validity
The validity of MDR and IVDR compliance depends on various factors, including the regulatory requirements, the type of medical device, and any subsequent changes or updates to regulations. Compliance with the MDR and IVDR is an ongoing process, and manufacturers are expected to maintain compliance throughout the lifecycle of their medical devices.
