MEDICAL DEVICES
Covering EU MDR 2017/745, IVDR 2017/746, UDI compliance, clinical evaluation, post-market surveillance, and international device registration strategies.
Q1: What are the principal differences between EU MDR 2017/745 and the former MDD 93/42/EEC?
A: EU MDR 2017/745 represents a comprehensive overhaul of the medical device regulatory framework, not merely an update to MDD. The most significant changes include: a substantially broadened scope (now covering certain aesthetic devices, software as a medical device (SaMD), and reprocessed single-use devices); stricter clinical evidence requirements, with a strong preference for device-specific clinical investigations over equivalence to predecessor products; enhanced post-market clinical follow-up (PMCF) and post-market surveillance (PMS) obligations with mandatory Periodic Safety Update Reports (PSURs) for Class IIa/IIb/III devices; a new Scrutiny Procedure for high-risk Class III devices and Class IIb implantables; compulsory Unique Device Identification (UDI) for all device classes; and mandatory registration in EUDAMED (the European database for medical devices) though full EUDAMED modules remain in phased rollout. Notified Bodies under MDR must be re-designated and many have significantly increased their review depth and timeline.
Q2: What is a Clinical Evaluation Report (CER) and what level of evidence does EU MDR require?
A: A CER is a written document that analyses and evaluates the clinical data pertaining to a medical device to verify clinical safety and performance and the acceptability of the benefit-risk profile under normal conditions of use. Under EU MDR, the CER must follow a systematic literature review methodology (MEDLINE, EMBASE, and device-specific databases), evaluate both favourable and unfavourable data, and for Class III devices and implantables generally require device-specific clinical investigation data rather than relying solely on equivalence. Equivalence claims (relying on data from a comparator device) are subject to strict technical, biological, and clinical equivalence criteria under MDCG 2020-5 guidance. The CER must be updated continuously as part of the PMCF cycle and be consistent with the Summary of Safety and Clinical Performance (SSCP) published in EUDAMED for implantable and Class III devices.
Q3: How does the EU IVDR 2017/746 differ from EU MDR, and which diagnostic products does it cover?
A: EU IVDR 2017/746 applies to in vitro diagnostic medical devices products used to examine samples derived from the human body (blood, tissue, urine) for diagnosis, monitoring, or screening purposes. Unlike the former IVDD 98/79/EC, EU IVDR introduces a risk-based classification system with four classes (A, B, C, D) replacing the IVDD’s list-based approach, and significantly increases Notified Body involvement: approximately 85% of IVD devices (by volume) previously self-certified as Class A now require third-party conformity assessment under IVDR. The regulation also introduces stricter requirements for companion diagnostics (co-developed with targeted therapies) and expanded performance evaluation obligations, including proof of analytical and clinical performance through prospective data collection where necessary. The full application date is 22 May 2022, with transition timelines for devices holding IVDD certificates.
Q4: What is a Post-Market Surveillance (PMS) system and what documents does it require?
A: A PMS system is the systematic process of collecting and reviewing experience gained from devices placed on the market, designed to identify any action needed to maintain ongoing conformity with EU MDR requirements. The required documentation varies by risk class. All manufacturers must maintain a PMS Plan (describing methods, data sources, and review frequency) and a PMS Report. For Class IIa, IIb, and III devices, the PMS Report is elevated to a Periodic Safety Update Report (PSUR) that summarises the conclusions of the post-market safety analysis and provides a risk-benefit assessment. PSURs must be submitted to the Notified Body annually for Class III/IIb, and at least every two years for Class IIa. Serious incidents identified through PMS must be reported to competent authorities as Field Safety Corrective Actions (FSCAs) or through EUDAMED’s vigilance module, with timelines of 15 days (serious incidents) or 2 days (serious public health threats).
Q5: What is a Unique Device Identifier (UDI) and is compliance mandatory under EU MDR?
A: Yes UDI compliance is mandatory under EU MDR for all device classes, with implementation dates phased by class. A UDI consists of two components: the Device Identifier (UDI-DI), which is a static code identifying the device model/configuration, and the Production Identifier (UDI-PI), which is a variable code containing information such as lot number, serial number, or expiry date. UDIs must be assigned by accredited Issuing Entities (GS1, HIBCC, or ICCBBA), physically affixed to the device label and all packaging levels, and registered in EUDAMED’s UDI database. For Class III and implantable devices, the UDI-DI must be stored in the patient implant card. Compliance timelines under MDR ran from 26 May 2021 (Class III and implantable Class IIb) through 26 May 2023 (all other Class IIb and Class IIa) and 26 May 2025 (Class I and Class A IVDR devices).
Q6: How should a device manufacturer approach regulatory submissions for markets outside the EU and US?
A: Global device registration strategy must balance the sequencing of submissions (major markets such as EU CE mark, FDA 510(k)/PMA, and Health Canada often inform others), documentation localisation requirements (translated labelling, local Authorised Representatives, country-specific test reports), and the degree to which each market accepts foreign approvals as a basis for national registration. Key considerations by region: ANVISA in Brazil requires INMETRO certification for certain device categories and a local Regulatory Affairs Representative (RAR); TGA in Australia accepts EU MDR technical documentation but applies its own conformity assessment procedures; PMDA in Japan requires Japanese labelling and often device-specific quality system inspections; CDSCO in India requires Form MD-14 applications and increasingly requests additional clinical data. A global submission strategy mapping mutual recognition potential, submission timelines, and local requirements across target markets is essential before committing to a launch sequence.
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