78 docs tagged with "mdr"

MDR Annex VIII, Rules 9–13 and Rule 22 govern active device classification. MDR Annex I, GSPR §14–16 and §19–22 cover design requirements for active and energy-emitting devices.

Regulatory basis - MDR Art. 7 (claims); MDR Art. 2(24) (intended purpose shaped by advertising); IVDR Art. 7 (IVDR claims). Advertising and promotional materials are part of the "information supplied by the manufacturer" and shape the legal intended purpose of the device.

MDR 2017/745, Annex IX and IVDR 2017/746, Annex IX. Annex IX is the most widely used conformity assessment route for Class IIa, IIb, III (MDR) and Class B, C, D (IVDR). It is the only permitted route for Class III (MDR) and Class D (IVDR).

MDR 2017/745, Annex X and IVDR 2017/746, Annex X. Annex X defines the EU type examination procedure. It is used in combination with Annex XI (Part A or B) and is available for Class IIa, IIb (MDR) and Class B, C (IVDR). Not available for Class III (MDR) or Class D (IVDR), which must use Annex IX.

Regulatory basis - MDR Art. 85 / IVDR Art. 80. The PSUR is required for higher-risk device classes and must be submitted to the notified body via EUDAMED. MDCG 2022-21 provides detailed guidance on PSUR content and format.

EU REP obligations are defined in MDR Article 11 and IVDR Article 11. Definitions appear in MDR Article 2(32) and IVDR Article 2(29).

Borderline product guidance is primarily in MDCG 2022-5. Drug-device combinations are addressed in MDR Art. 1(8)–(9), MDR Annex I §12.2, and relevant EMA guidance. ATMP combination products are governed by Regulation (EC) No 1394/2007.

MDR 2017/745, Annex I, Chapter I (GSPR 1–5) and equivalent provisions in IVDR 2017/746, Annex I, Chapter I. These requirements are foundational — they apply to every device regardless of type or class.

MDR 2017/745, Annex I, Chapter II (GSPR 6–22) and equivalent provisions in IVDR 2017/746, Annex I, Chapter II. These are specific technical requirements for how devices must be designed and manufactured.

MDR 2017/745, Annex I, Chapter III, Section 23 and IVDR 2017/746, Annex I, Chapter III, Section 20. These are the labelling and IFU requirements as part of the GSPR. Post-market labelling obligations are covered separately in Labelling & advertising.

MDR 2017/745, Article 51 and Annex VIII. MDR uses a four-class system with Class I subdivided into sub-classes based on sterility, measuring function, and reusable surgical instrument status.

MDR Art. 52(7) and Annex IV. Class I devices (standard) do not require notified body involvement. The manufacturer self-declares conformity by signing an EU Declaration of Conformity after completing all required steps.

MDR 2017/745, Annex VIII. All 22 classification rules must be applied systematically. Where more than one rule applies, the highest resulting class prevails.

MDR Art. 61 and Annex XIV. Clinical evaluation is mandatory for all MDR devices regardless of class. It is a continuous, lifecycle process — not a one-time pre-market exercise.

MDR Annex XIV Part A, Section 4. The CER is the written output of the clinical evaluation process. It must be reviewed and updated throughout the device lifecycle and is a mandatory technical documentation element.

MDR Art. 62–82 and Annex XV. Clinical investigations — structured studies in human subjects — are the gold standard for clinical evidence. They are mandatory for certain device classes and may be required when existing evidence is insufficient.

Regulatory basis - MDR Art. 59 (compassionate use); MDR Art. 53 (humanitarian device exemptions via custom-made pathway); MDR Art. 62(4)(f) (compassionate use within clinical investigations); member state national provisions for named-patient / hospital exemption access.

Regulatory basis - MDR Art. 93–97 / IVDR Art. 88–92. National competent authorities have broad powers to investigate, restrict, and remove medical devices from the EU market. The European Commission can intervene at EU level where national actions are insufficient.

MDR conformity assessment procedures are set out in MDR Art. 52 and Annexes IX–XI. IVDR equivalents are in IVDR Art. 48 and Annexes IX–XI. The EU Declaration of Conformity is required under MDR Art. 19 / IVDR Art. 17 and MDR Annex IV / IVDR Annex IV.

MDR Art. 2(3) (definition); MDR Art. 52(8) (conformity assessment); MDR Annex XIII (documentation requirements for custom-made devices). Custom-made devices are subject to a specific, lighter-touch regulatory pathway but must still meet all applicable GSPR.

MDR Annex II, Section 3 and IVDR Annex II, Section 3. This section of the technical documentation covers how the device was designed and how it is manufactured — the information necessary to ensure reproducibility and traceability.

MDR Annex II, Section 1 and IVDR Annex II, Section 1. The device description and specification is the foundational section of technical documentation — it defines what the device is, what it does, and for whom.

Regulatory basis - MDR Art. 28–29 / IVDR Art. 25–26. Manufacturers must register all devices placed on the EU market in EUDAMED, linked to the Basic UDI-DI. Registration is a prerequisite for placing the device on the market within the applicable class timelines.

MDR Annex VIII Rule 14 (classification); MDR Art. 1(8)–(9) (drug-device combination products); MDR Annex I §8 (GSPR). Integral drug-device combinations where the device action is principal are Class III under MDR and require EMA or NCA consultation.

MDR Annex VIII Rules 17–18 (classification); MDR Annex I §13 (GSPR); EN ISO 22442 series (animal tissue requirements); European Pharmacopoeia Chapter 5.2.8 (TSE risk minimisation). Devices made from non-viable human tissue are Class III; non-viable animal tissue devices are also Class III (with some Class IIb exceptions).

Regulatory basis - MDR Art. 10(8) / IVDR Art. 10(8) — manufacturers must maintain records that allow identification of all customers who received a device, enabling effective recalls and FSCAs. Importers and distributors have parallel obligations under MDR Art. 13(5) and Art. 14(5).

Distributor obligations are defined in MDR Article 14 and IVDR Article 14. Definitions appear in MDR Article 2(34) and IVDR Article 2(31).

Regulatory basis - MDR Art. 30 / IVDR Art. 27. All manufacturers, EU authorised representatives, importers, and (in some cases) distributors must register as economic operators in EUDAMED and receive a Single Registration Number (SRN).

MDR Art. 61(4)–(5) and Annex XIV §3. Equivalence is a tool for leveraging existing clinical data from a comparable device in lieu of a new clinical investigation. Its use is significantly more restricted under MDR than under the previous MDD.

MDR Art. 19 and Annex IV (Declaration of Conformity); MDR Art. 20 (CE marking). Equivalent IVDR provisions: Art. 17 and Annex IV (DoC); Art. 18 (CE marking).

Regulatory basis - MDR Art. 28–33 / IVDR Art. 25–30. EUDAMED is the European database on medical devices — the central information infrastructure underpinning MDR and IVDR. Manufacturers, EU REPs, importers, and distributors must all register as economic operators.

Regulatory basis - MDR Art. 27(3)–(4) and Art. 28–29 / IVDR Art. 24(3)–(4) and Art. 25–26. Manufacturers must register their devices in EUDAMED using the UDI as the primary identifier before placing devices on the EU market.

Regulatory basis - MDR Art. 92 and Art. 100–105 / IVDR Art. 87 and Art. 97–102. EUDAMED is the central EU information system for medical devices, including the vigilance module for reporting serious incidents and FSCAs.

Regulatory basis - MDR Art. 89(3) / IVDR Art. 84(3). A field safety notice (FSN) is the communication issued by a manufacturer to inform customers, distributors, and users of an FSCA and what action they need to take. MDCG 2023-3 provides a template.

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) — terms are drawn from official definitions in Article 2 of each regulation unless otherwise noted.

Both MDR 2017/745 and IVDR 2017/746. The GSPR checklist (cross-reference table) is a mandatory component of the technical documentation under Annex II of both regulations.

MDR Annex II, Section 4 and IVDR Annex II, Section 4. The GSPR cross-reference table is a mandatory component of technical documentation linking each applicable general safety and performance requirement to the evidence of conformity.

MDR classification rules are in Annex VIII of MDR 2017/745. IVDR classification rules are in Annex VIII of IVDR 2017/746. Classification determines the conformity assessment route, notified body involvement, and post-market obligations.

Regulatory basis - MDR Art. 87 / IVDR Art. 82 require reports to be submitted to the NCA of the member state(s) where the incident occurred. EUDAMED is the primary reporting platform; some NCAs also accept or require national-format reports.

MDR Art. 2(5) (definition); MDR Annex VIII Rule 8 (classification); MDR Art. 18 and Annex XV §2.12 (implant card); MDR Annex I §22–23 (GSPR for implantables). Active implantable devices are governed by the same regulation (AIMDs are now Class III under MDR).

The legislative framework beneath MDR and IVDR comprises implementing acts (Commission), delegated acts (Commission), Common Specifications (Commission via implementing act), and harmonised European standards (CEN/CENELEC under Commission mandate).

Importer obligations are defined in MDR Article 13 and IVDR Article 13. Definitions appear in MDR Article 2(33) and IVDR Article 2(30).

Regulatory basis - MDR Annex I §23 / IVDR Annex I §20 (GSPR labelling requirements); MDR Art. 10(11) (labelling obligations on manufacturers). Language requirements vary by member state. Post-market labelling obligations extend to maintaining current labelling as the device and evidence evolve.

MDR Art. 120 (transitional provisions for MDD/AIMDD devices); IVDR Art. 110 (transitional provisions for IVDD devices); Regulation (EU) 2023/607 (amended MDR transitional dates); Regulation (EU) 2024/1860 (amended IVDR transitional dates).

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)

MDR Article 10 and IVDR Article 10 set out the general obligations of manufacturers. Definitions appear in MDR Article 2(30) and IVDR Article 2(27).

Regulatory basis - MDR Art. 93–97 / IVDR Art. 88–92. Market surveillance is the system of NCA activities that ensures devices on the EU market comply with MDR/IVDR requirements. It is distinct from — but complementary to — the manufacturer's own post-market surveillance system.

Annexes I–XVII of Regulation (EU) 2017/745 (MDR). The annexes contain the detailed technical, procedural, and administrative requirements that implement the principles set out in the articles.

Regulatory basis - MDR = Regulation (EU) 2017/745 | IVDR = Regulation (EU) 2017/746. Both regulations are mutually exclusive — a product is governed by one or the other, never both simultaneously.

Both MDR 2017/745 and IVDR 2017/746. This section covers requirements for non-EU manufacturers placing devices on the EU market, EU REP obligations, and how EU MDR/IVDR relates to non-EU regulatory systems.

Both MDR 2017/745 and IVDR 2017/746. Each regulation contains its own Annex I (GSPR), with mostly parallel structure and some IVDR-specific elements.

Both MDR 2017/745 and IVDR 2017/746. Post-market obligations begin the moment a device is placed on the market and continue until the device is withdrawn from service.

The PRRC requirement is established in MDR Article 15 and IVDR Article 15.

Regulatory basis - MDR Art. 83–86 / IVDR Art. 78–81. PMS is a proactive, systematic process that all manufacturers must implement. The depth and reporting frequency scale with device risk class.

MDR Annex III and IVDR Annex III define the post-market technical documentation requirements. Key documents are the PMS plan, PMS report / PSUR, and PMCF plan and evaluation report (MDR) or PMPF plan and evaluation report (IVDR).

Regulatory basis - MDR Art. 89 and Art. 95 / IVDR Art. 84 and Art. 90. EU medical device recalls are a subset of FSCAs. Unlike some other regulatory systems, the EU does not have a single standardised recall classification system — instead, the risk assessment under ISO 14971 and NCA discretion determine the urgency and scope.

MDR 2017/745 and IVDR 2017/746 and their amending regulations. This page tracks significant amendments; always verify current status in the Official Journal.

MDR Art. 51(2) and IVDR Art. 47(2) empower the European Commission to reclassify devices or device categories by implementing act. Scientific opinions informing reclassification were historically provided by SCENIHR (now replaced by SAG-MD and the MDCG).

The full text of MDR 2017/745 is available in the Official Journal of the EU: OJ L 117, 5.5.2017, p. 1–175. All article references on this site refer to the MDR as amended, including amendments made by Regulation (EU) 2020/561 and Regulation (EU) 2023/607.

Both MDR 2017/745 and IVDR 2017/746

Regulatory basis - MDR Art. 87(5)–(8) / IVDR Art. 82(5)–(8). Timeframes run from the date the manufacturer becomes aware of the incident. EUDAMED is the reporting platform for EU vigilance reports.

Risk management is required by GSPR §1 and §2 of MDR Annex I and IVDR Annex I. The harmonised standard EN ISO 14971:2019 provides the implementation framework and creates a presumption of conformity with the relevant GSPR when applied.

Regulatory basis - MDR Art. 2(65) and Art. 87 / IVDR Art. 2(67) and Art. 82. The definitions of serious incident and near-miss determine the scope of mandatory vigilance reporting.

MDR Art. 2(8) (single-use definition); MDR Art. 17 (reprocessing of single-use devices); MDR Annex I §23.4(h) (IFU requirements for single-use designation). Reprocessing of single-use devices is regulated — not prohibited — but the reprocessor takes on full manufacturer obligations.

MDR software classification is governed by Annex VIII, Rule 11 of MDR 2017/745. IVDR software follows the same class assignment rules as other IVDs under IVDR Annex VIII. MDCG 2021-24 provides authoritative guidance on MDR Rule 11 application.

MDR Art. 2(1) (software included in definition); MDR Annex VIII Rule 11 (classification); MDR Annex I §17 and §21 (GSPR for software). MDCG 2019-11 and MDCG 2021-24 provide detailed guidance. For IVD software: IVDR Annex VIII Rules 1–7.

MDR Art. 22 governs systems and procedure packs — combinations of products that are assembled together for a specific medical purpose. The person assembling a system or procedure pack takes on specific regulatory obligations.

MDR 2017/745, Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance). Equivalent provisions in IVDR 2017/746, Annex II and III. Technical documentation must be compiled before CE marking and maintained throughout the device lifecycle.

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)

Regulatory basis - MDR Art. 27(4)–(6) / IVDR Art. 24(4)–(6) and MDR Annex VI Part C / IVDR Annex VI Part C. These provisions specify where and how the UDI carrier must appear on device labelling.

Both MDR 2017/745 and IVDR 2017/746. UDI requirements are set out primarily in MDR Art. 27 / IVDR Art. 24 and MDR Annex VI / IVDR Annex VI.

Regulatory basis - MDR Annex VI Part B and C and IVDR Annex VI Part B and C. The UDI consists of a Device Identifier (UDI-DI) and a Production Identifier (UDI-PI). Understanding the distinction is fundamental to UDI system compliance.

Both MDR 2017/745 and IVDR 2017/746. International clinical data — generated outside the EU — can be used in clinical evaluations and performance evaluations, subject to certain conditions.

Regulatory basis - This page is based on Article 2(1) of Regulation (EU) 2017/745 (MDR). The definition is central to determining whether your product requires MDR compliance.

Regulatory basis - Exclusions from the MDR are set out primarily in Article 1(5) and 1(6) of Regulation (EU) 2017/745. Equivalent IVDR exclusions appear in Article 1(4) and 1(5) of Regulation (EU) 2017/746.

Regulatory basis - MDR Art. 87 and IVDR Art. 82 define the reporting obligations for serious incidents and field safety corrective actions. Manufacturers must report to the National Competent Authority of the member state(s) where the incident occurred or the FSCA is being taken.

Regulatory basis - MDR Art. 2(68) and Art. 89 / IVDR Art. 2(70) and Art. 84. An FSCA is any corrective action taken by a manufacturer to reduce a risk of death or serious deterioration in health associated with a device already placed on the market. FSCAs must be notified to NCAs.

MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)