Q: What is EU MDR 2017/745 and how does it differ from the old MDD?
A: EU MDR 2017/745 (Medical Device Regulation) replaced the Medical Device Directive (MDD 93/42/EEC) and is directly applicable law across all EU member states — not a directive requiring national transposition. Key improvements over the MDD include: stricter and more extensive clinical evidence requirements for all classes; mandatory Post-Market Clinical Follow-Up (PMCF) plans; enhanced Unique Device Identification (UDI) system with EUDAMED registration; increased Notified Body scrutiny including a scrutiny procedure for Class III; mandatory Summary of Safety and Clinical Performance (SSCP) for implantables and Class III; and an explicit Economic Operator accountability chain (manufacturer, AR, importer, distributor).
Q: How are medical devices classified under EU MDR and what does the classification determine?
A: EU MDR classifies devices into four risk classes: Class I (lowest risk — e.g., bandages, spectacle frames); Class IIa (moderate risk — e.g., hearing aids, dental crowns); Class IIb (higher risk — e.g., ventilators, bone screws); and Class III (highest risk — e.g., cardiac implants, CNS devices). Classification is governed by 22 rules in Annex VIII based on invasiveness, duration of contact, intended anatomical location, and use of energy. Classification determines the conformity assessment route: Class I (manufacturer self-declaration for most); IIa/IIb/III require a Notified Body. Higher class = more clinical evidence, more frequent PSUR updates, and greater post-market obligations.
Q: What is a Clinical Evaluation Report (CER) for a medical device and what must it contain?
A: A CER is the mandatory document demonstrating that a medical device meets the relevant safety and performance requirements on the basis of clinical data. Required for CE marking under EU MDR. It must: follow a systematic literature search methodology (MEDDEV 2.7/1 rev 4 / MDCG guidance); appraise clinical data from equivalent devices (with documented equivalence justification); assess clinical benefits vs. residual risks; identify knowledge gaps addressed by PMCF; and be regularly updated with PMS data. For Class IIb and III devices, the Notified Body scrutinizes the CER during conformity assessment. CERs must be authored by qualified clinical evaluators.
Q: What are the FDA pathways for medical device clearance and approval?
A: FDA offers four main pathways: 510(k) Premarket Notification — demonstrates substantial equivalence to a legally marketed predicate device; used for most Class II and some Class I devices. Premarket Approval (PMA) — required for Class III devices; demands clinical evidence of safety and effectiveness; most rigorous pathway. De Novo Classification — for novel low-to-moderate risk devices without a predicate; creates a new classification and can serve as a predicate. Humanitarian Device Exemption (HDE) — for devices treating or diagnosing diseases affecting fewer than 8,000 patients/year in the US. Pathway selection depends on device risk class, predicate availability, and clinical evidence.
Q: What is ISO 13485 and is it legally required for medical device manufacturers?
A: ISO 13485 is the internationally recognized Quality Management System standard specific to medical devices. While not universally legally mandated as a standalone requirement, it is: required for CE marking under EU MDR (Annex IX, X, XI reference a QMS meeting MDR requirements, which ISO 13485 satisfies); referenced by Health Canada as required for Canadian device licences; widely expected by TGA (Australia), ANVISA (Brazil), PMDA (Japan), and CDSCO (India); and recognized by FDA as a quality systems baseline alongside 21 CFR Part 820. ISO 13485:2016 certification demonstrates that a manufacturer’s QMS meets design, production, and post-market surveillance obligations.
Q: What is Post-Market Surveillance (PMS) for medical devices and what are its EU MDR obligations?
A: PMS is the systematic process of proactively collecting and analyzing real-world data on a CE-marked device during its commercial life. Under EU MDR (Annex III), manufacturers must maintain a PMS system and prepare: a Periodic Safety Update Report (PSUR) for Class IIa, IIb, and III devices (annually for IIb/III; every 2 years for IIa); or a PMS Report (PMSR) for Class I devices. PMS data feeds back into the Clinical Evaluation Report, PMCF plan, and risk management file. Serious incident vigilance reports must be submitted to Competent Authorities within 15 days (serious) or 2 days (immediately life-threatening). The PSUR and CER must be kept aligned and current.
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