Q: What is the UDI (Unique Device Identifier) system and is compliance mandatory?
A: The UDI system assigns a globally unique identifier to each medical device — comprising a Device Identifier (DI, static — identifies the specific version/model) and a Production Identifier (PI, variable — batch, serial number, or expiry date). In the EU, UDI application on device labels and carrier submission to EUDAMED is mandatory under MDR, phased by class (Class III from 2021; IIa/IIb from 2023; Class I from 2025). FDA’s UDI Rule requires label compliance and submission to the Global Unique Device Identification Database (GUDID). UDI enables traceability, accelerates recall management, and links adverse event reports to specific device versions.
Q: What is EUDAMED and what information must medical device manufacturers submit?
A: EUDAMED (European Database on Medical Devices) is the EU’s central IT system supporting MDR implementation. Manufacturers must: register their legal entity (Actor Registration module); register all devices with UDI-DI data (UDI & Device Registration module); submit Notified Body certificates (Notified Bodies and Certificates module); upload Summary of Safety and Clinical Performance (SSCP) for implantables and Class III devices; and report serious incidents and field safety corrective actions (FSCA) via the Vigilance module. EUDAMED increases regulatory transparency — parts of it are publicly accessible to patients and healthcare professionals.
Q: How does medical device registration differ between EU, USA, India, and Australia?
A: EU: CE marking via MDR 2017/745 — requires Notified Body assessment (Class IIa+), Technical Documentation meeting GSPRs, CER, ISO 13485 QMS, EUDAMED registration, and an EU Authorized Representative for non-EU manufacturers. USA: FDA 510(k)/PMA/De Novo clearance/approval — establishment registration, device listing, QSR (21 CFR 820) compliance required; no Notified Body but rigorous FDA review. India: CDSCO Medical Device Rules 2017 — Class A/B devices licensed by State Licensing Authorities; Class C/D by CDSCO Central Licence; Indian Agent required for imported devices. Australia: TGA via ARTG inclusion — risk-based classification, conformity assessment (often ISO 13485-based), and ARTG registration required. Each jurisdiction has distinct fees, timelines, post-market requirements, and language/labeling rules.
Q: What is a Summary of Safety and Clinical Performance (SSCP) and is it mandatory?
A: The SSCP is a mandatory public-facing document under EU MDR required for all Class III devices and all implantable devices. It summarizes: device description and purpose; safety and performance summary from the CER; residual risks and uncertainties; clinical investigation references; post-market surveillance data; and revision history. It must be written in plain language accessible to patients and healthcare professionals, provided in all relevant EU official languages, validated and uploaded to EUDAMED by the Notified Body. The SSCP must be updated annually or whenever significant new safety information arises — making ongoing maintenance a regulatory obligation.
Q: What is an EU Authorized Representative (AR) and when is one required?
A: Non-EU manufacturers placing medical devices on the EU/EEA market must appoint an EU-based Authorized Representative (AR) — a natural or legal person who acts as the regulatory interface with EU Competent Authorities. The AR registers in EUDAMED, signs the EU Declaration of Conformity alongside the manufacturer, and bears joint liability for non-compliant devices. Post-Brexit, non-UK manufacturers placing devices on the Great Britain market (MHRA regulated) must similarly appoint a UK Responsible Person (UKRP). Failure to appoint an AR/UKRP is grounds for refusing market access.
Q: What is the De Novo classification pathway at FDA and when should it be used?
A: The De Novo pathway is FDA’s route for novel, low-to-moderate risk devices (typically Class II equivalent) that lack a legally marketed predicate — meaning a 510(k) submission is not possible. Upon granting De Novo classification, FDA creates a new device type with appropriate special controls, which can then be used as a predicate for future 510(k) submissions. De Novo is most appropriate when: a device represents genuinely new technology; the device’s risk profile supports Class II (not Class III); and the manufacturer can demonstrate reasonable assurance of safety and effectiveness. Average De Novo review time is approximately 12–18 months.
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