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EU Regulation 2017/745 (MDR) Article 120, as amended by Regulation 2023/607, extended the transitional provisions for legacy devices certified under MDD 93/42/EEC or AIMDD 90/385/EEC. The revised timeline depends on device risk class: Class III implantables and Class IIb implantable devices (except sutures, staples and dental fillings) must comply with the MDR by 31 December 2027. Class IIb non-implantable and Class IIa devices, as well as Class I devices requiring Notified Body involvement, have a deadline of 31 December 2028. Class I sterile devices and devices with a measuring function have a deadline of 31 December 2028. To benefit from extended transitional provisions, manufacturers must: have applied for MDR certification with a Notified Body before 26 May 2024; have a signed written agreement with a Notified Body in place; and ensure the device does not present an unacceptable risk to patients, users or third parties. Devices placed on the market under MDD/AIMDD certificates can be distributed until 31 December 2025 for Class III implantables and 31 December 2026 for other classes, provided the device was placed on the market before the MDR application. IgeraIndustria maps specific device classes against the applicable transitional deadline and identifies which conditions must be met to maintain market access.

The FDA Premarket Notification (510(k)) pathway requires the applicant to demonstrate substantial equivalence to a legally marketed predicate device — one that was on the market before 28 May 1976 or subsequently cleared through 510(k). Substantial equivalence means the device has the same intended use as the predicate and the same or different technological characteristics that do not raise new safety and effectiveness questions. The FDA target review time is 90 days. 510(k) applies to most Class II devices and some Class I devices requiring special controls. The Premarket Approval (PMA) pathway applies to Class III devices (those that support or sustain human life, prevent impairment of human health, or present a potential unreasonable risk of illness or injury) and to novel devices without a predicate (De Novo pathway). PMA requires valid scientific evidence — typically one or two well-controlled clinical investigations — demonstrating reasonable assurance of safety and effectiveness. PMA review time averages 180 days for a standard review and can exceed 3 years for complex Class III devices. Key practical differences: 510(k) is substantially equivalent comparison; PMA is independent safety/effectiveness demonstration. A “predicate creep” chain of 510(k) clearances can introduce devices significantly different from the original predicate without triggering PMA requirements — FDA’s De Novo process was created to address this gap.

Under EU MDR 2017/745 Article 27 and Commission Regulation 2017/2185 (UDI Regulation), the Unique Device Identifier has two mandatory components. The UDI-DI (Device Identifier) is a mandatory fixed part of the UDI that identifies the device model — it is the key used to access information in EUDAMED and changes whenever any characteristic that would require a new declaration of conformity changes. The UDI-PI (Production Identifier) is the variable part that identifies the unit of device production and includes the serial number (mandatory for Class III and implantable devices), lot or batch number (mandatory for Class IIa, IIb and III), manufacturing date or expiry date as applicable. Manufacturers must register the UDI-DI for each device in EUDAMED’s UDI database (UDI-DI registration is mandatory and publicly accessible). UDI-PI is not registered in EUDAMED but must appear on the device label. All Class III and implantable devices must carry the UDI on the device itself (“implant card” requirement). Economic operators (importers, distributors) must store and transmit UDIs throughout the supply chain and are required to register in EUDAMED’s economic operator database. IgeraIndustria clarifies UDI-DI change triggers, EUDAMED registration obligations by actor role, and identifies which device types require UDI on the device itself versus on packaging only.

ISO 13485:2016 clause 7.3 establishes the design and development control framework — equivalent in scope to FDA 21 CFR 820.30 design controls. The requirement covers: 7.3.2 Design and development planning — a documented plan covering activities, responsibilities, review, verification and validation stages, and interfaces between different groups; 7.3.3 Design inputs — functional, performance and safety requirements, regulatory requirements, risk management inputs (ISO 14971), usability inputs (IEC 62366); 7.3.4 Design outputs — documented outputs that provide the basis for purchasing, production and service provision, including acceptance criteria for incoming components; 7.3.5 Design review — systematic reviews at defined stages with participants from all functions concerned, records of reviews and required actions; 7.3.6 Design verification — confirmation that design outputs meet design inputs, with objective evidence; 7.3.7 Design validation — confirmation that the final device meets specified requirements for intended use, including clinical evaluation or performance studies; 7.3.9 Control of design and development changes — all changes must be reviewed, verified, validated and approved before implementation. The most common audit non-conformity in clause 7.3 is incomplete traceability from user needs through design inputs, outputs, verification and validation — the design history file must allow a full forward and backward trace at any point.

Under EU MDR 2017/745 Annex XIV, clinical evidence for CE marking requires two complementary activities. The Clinical Evaluation Report (CER), governed by MDCG 2020-13 guidance, is a systematic review and critical analysis of the available clinical data for the device. It covers: literature data from equivalent devices (with documented equivalence justification under Annex XIV Part A); clinical investigation results; spontaneous complaints and vigilance data; PMCF data. The CER must conclude that the device achieves the claimed performance, that the benefit-risk profile is favourable, and that clinical evidence is consistent with the GSPR (Annex I). For Class III and implantable devices, equivalence to a device of another manufacturer is no longer allowed without direct access to the equivalent device’s technical documentation — in practice this means most Class III manufacturers must conduct their own clinical investigations. The Post-Market Clinical Follow-Up (PMCF) is an ongoing clinical data collection activity after CE marking, defined in Annex XIV Part B and detailed in MDCG 2020-7 guidance. PMCF must cover: long-term safety outcomes; residual risks and side effects; clinical performance over device lifetime; emerging risks from post-market surveillance. PMCF data feeds back into the CER update (mandatory annually for Class III and Class IIb implantables, every 2-5 years for others) and into the Summary of Safety and Clinical Performance (SSCP) published in EUDAMED. IgeraIndustria identifies the CER update frequency for specific device classes, maps PMCF methods (surveys, registry studies, PMCF studies) to the MDCG guidance requirements, and flags missing clinical data gaps.

The EU Notified Body (NB) capacity crisis is a structural challenge for MDR and IVDR certification: as of 2024, only 43 NBs are designated for MDR compared to 80+ under MDD, and average waiting times for initial audit scheduling have reached 12-24 months for some NBs. Practical strategies for manufacturers facing certification delays include: (1) Multi-NB strategy — applying to secondary NBs while waiting for preferred NB, accepting that certificate reissuance may be needed later; (2) Prioritising device portfolio — focusing NB resources on highest-revenue or highest-risk devices first, using MDR Article 120 transitional provisions for lower-risk legacy devices where possible; (3) BSI, TÜV Rheinland and DEKRA have the largest MDR designation scopes — manufacturers in specific device categories should verify NB designation scope before applying; (4) MHRA UKCA certification — post-Brexit, UKCA is a separate pathway via UK-approved bodies and does not require an EU NB, providing market access continuity for the UK market; (5) Article 97 “without NB” Class I devices: a Category I device (non-sterile, no measuring function) can be self-certified under MDR without NB involvement, simplifying the EU pathway for Class I devices while MDR certification is pursued; (6) EUDAMED registration completeness — ensuring all economic operator and device registrations are complete reduces the risk of NB refusing to issue certificates due to missing database entries. IgeraIndustria maps the NB capacity situation by device category, MDR Annex IX/X pathway selection criteria, and UKCA equivalence analysis for manufacturers targeting the UK market.