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: Familiarise yourself with the specific requirements outlined in MDR and IVDR that apply to your medical devices or in vitro diagnostic medical devices, according to the MHRA rules.
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.
Post-Market Surveillance: Establish robust post-market surveillance procedures to monitor the performance, safety, and quality of your devices in the market.
Labelling and UDI Compliance: Ensure that your labelling complies with MDR and IVDR requirements, including the new Unique Device Identification (UDI) system.
Engage Notified Body: Engage with a notified body accredited for MDR and IVDR certifications and submit a processing application, along with technical documentation and QMS details.
Technical and Clinical Review: The notified body examines the documentation, product specifications, risk management, reviews test results, and assesses compliance with regulations and standards. The notified body also reviews clinical evaluation reports and benefit-risk analysis.
Recommendation or Refusal: After assessing the QMS and clinical evaluations, the notified body makes a decision.
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 according to the classification rules of the MDR and IVDR.
Identify areas that need improvement or alignment with MDR and IVDR requirements
Assist in updating technical documentation, product specifications, and quality manuals to meet the enhanced quality and risk management expectations in accordance with the MDR.
Assist in obtaining the necessary certifications or conformity assessments required for market entry.
Regulatory Requirements for MDR and IVDR Compliance
Timeline
Medical devices, including custom-made devices, that adhere to the EU medical devices regulation (EU MDR) and in-vitro devices compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be marketed in the Great Britain market up until 30 June 2030.
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.
