510k vs MDR FAQ
Q: What is the difference between FDA and EU MDR regulations for medical device approvals?
A: The FDA (U.S. Food and Drug Administration) and EU MDR (European Union Medical Device Regulation) have differences in definitions, procedures, risk classifications, and documentation requirements for medical device approvals.
Q: How are FDA and EU MDR regulations aligned now?
A: The recent implementation of EU MDR has brought FDA and EU regulations closer together, especially in terms of ISO 13485-compliant quality system requirements, conformity assessment prerequisites, and harmonized standards like IMDRF standards for Software as a Medical Device (SaMD).
Q: How does the EU MDR differ from FDA regulations in terms of instructions and requirements?
A: The EU MDR provides more comprehensive instructions, including procedures for device registration, requirements for Quality Management systems, clinical data, CE certification process, economic operator obligations, post-market surveillance (PMS), confidentiality, financial responsibilities, data protection, essential requirements (GSPR), and notified body conditions.
Q: How does device classification differ between FDA and MDR?
A: The FDA categorizes devices based on risk. Class I and Class II devices are governed by the 510(k) standard, while Class III devices, like implanted devices, require Pre-Market Approval (PMA) with extensive risk-benefit analysis, performance, and safety validation. The EU MDR has four categories: non-invasive devices, invasive medical devices, active medical devices, and a special category including contraceptive, disinfectant, and radiological diagnostic medical devices, each with risk-based classifications.
Q: What are the technical documentation and risk evaluation requirements for FDA and MDR?
A: Both FDA and EU MDR require Technical Documentation and risk evaluation. However, EU MDR mandates comprehensive technical documentation and extensive risk evaluation for Class IIb and Class III devices, involving audits by notified bodies. Clinical Evaluation is also a significant departure from the FDA approach for EU MDR.
Q: What are the Unique Device Identification (UDI) requirements for FDA and EU MDR?
A: Both FDA and EU MDR have UDI requirements for medical devices, involving alphanumeric or numeric characters for clear identification. The EU MDR also requires a basic UDI-DI for organizing devices into EUDAMED, their regulatory database.
Q: How do FDA and EU MDR differ in the classification process for connected medical devices?
A: The FDA primarily classifies connected devices based on a predicate device comparison, whereas the EU MDR uses rules, such as 22 waterfalling rules for medical device software (MDSW), to categorize connected devices.
Q: Can the same documentation be used for both MDR and 510k approvals?
A: Yes and no. While most requirements for FDA and EU MDR regulations are similar, there are some differences in report formatting and specific requirements. A current ISO 13485:2016 Quality Management System can help comply with both sets of regulations.
Q: What is the Medical Device Compliance process for FDA and EU MDR?
A: Both FDA and EU MDR compliance involve ongoing challenges that require regular inspection and upkeep. The regulations are moving towards tougher evaluations and audits of QMS and product information, and manufacturers must keep up with evolving regulations to meet device submission requirements.
Gap Assessment
Supporting an FDA 510k to MDR transition
