FAQs

  • Answer: Start by determining your device classification in your target markets (EU, UK, US, etc.). This influences your regulatory pathway, documentation requirements, and whether clinical evaluation or notified body involvement is needed.

  • Answer:

    • EU MDR (2017/745): Applies to the European Union, with stricter rules on clinical evaluation and post-market surveillance.

    • UK MDR (based on older EU directives): Currently used in Great Britain with upcoming reform.

    • FDA (US): Uses a risk-based system (Class I, II, III) with distinct routes like 510(k), De Novo, and PMA.

  • Answer: Not always, but it's strongly recommended. ISO 13485 is required for CE marking in the EU and is recognised by regulators like the FDA and MHRA. It demonstrates a compliant quality management system.

  • Answer: It's a detailed document that demonstrates your device complies with regulatory requirements. It includes design info, risk management, clinical evaluation, labelling, and more. Required for CE marking in the EU.

  • Answer: It’s a premarket submission to the FDA for Class II devices to prove substantial equivalence to a legally marketed device. It typically includes performance data, device description, and labelling.

  • Answer: It varies widely.

    • EU MDR: 6–12 months or more (notified body backlog is common).

    • FDA 510(k): ~90 calendar days (excluding time to address deficiencies).

    • UK MDR: May require UKCA marking from 2025 onward; timelines vary.

  • Answer: Most likely, yes. Clinical evaluation is mandatory under EU MDR. FDA submissions often require clinical or performance data depending on risk level and predicate device.

  • Answer: UDI (Unique Device Identification) is a system for tracking medical devices through distribution and use. It's mandatory in the EU (with EUDAMED), US, and other regions. Implementation deadlines vary.

  • Answer: PMS refers to monitoring the safety and performance of your device after it's on the market. EU MDR requires a PMS plan and periodic safety update reports (PSUR). It’s also key in the FDA's QSR.

  • Answer: In the EU, Class IIa, IIb, and III devices require a Notified Body for conformity assessment. Class I (non-sterile, non-measuring, non-reusable) usually do not.

  • Answer:

    • Incomplete or inconsistent documentation

    • Poorly structured technical files

    • Lack of clinical evidence

    • Inadequate quality management systems

    • Notified body capacity issues

  • Answer: Yes. Software as a Medical Device (SaMD) must comply with specific classification rules and cybersecurity standards. EU MDR has tightened scrutiny on software risk.

  • Answer:

    • Conduct internal audits regularly

    • Maintain complete and up-to-date documentation

    • Ensure your team is trained and aware of your QMS

    • Use readiness checklists and audit simulation tools

  • Answer: No. Each region (EU, UK, US, Canada, etc.) has its own regulatory requirements. However, documentation can often be adapted from one market to another with some effort.

  • Answer: Ideally before prototyping. Early regulatory planning can reduce rework, guide product design, and align development with market expectations - saving time and cost.