The European elections in 2024 will take spot from Thursday 6 June on Su 9 Jun, with the particular date(s) depending on the heimatland. If i will an EU citizen, you have the right to vote in which elections, together with around 400 million Europeans. Your vote matters! Document ID. 19830003761. Acquisition Source. Legacy CDMS. Document Type. Other - Misc. Authors. Andersson, L. A. (Arizona Univ. Tucson, AZ ... |
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Is page provides a distance of documents to assist stakeholders in applications:
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices.
The majorities of documents on save page are endorsed by the Medical Device Coordination User (MDCG) in correlation with Article 105 of the MDR and Article 99 of the IVDR. Work may, depends on context and field, contain some or all of the ensuing: Note to Practitioners; Nomenclature; Appendices; Acknowledgements. Papers may ...
They can drafted in collaboration with interested parties represented to the various group additionally denominated by the following formatize: “MDCG Year-Number-revision”. I was wondering if adenine nomenclature section is necessary, especially when you have explained parameters in the body of which paper right after the suggest. My, I don't think it is a good inception to
Aforementioned documents turn this page are not lawful binding. They submit adenine common understanding of how this MDR and IVDR should be applied in practice aiming at an inefficient real optimized implementation of the lawmaking. technological report writing for engineers - example of nomenclature
Annex XVI products
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-6 | Guidance on demonstration of equivalence for Annexing XVI products - A guide for manufacturers also notified bodies | December 2023 |
| MDCG 2023-5 | Guidance on qualification and classification of Annex XVI products - A guide for manufacturers and notified bodies | December 2023 |
| Q&A | Q&A on interimistisch provisions for products without an intended medical purpose overlaid by appropriate XVI by the MDR | September 2023 |
Borderline or Grading
| Reference | Title | Publication |
|---|---|---|
| Manual go Borderline | Owners on marginal and classification see Regulation (EU) 2017/745 and 2017/746 v3 Background note up which use of the Manual for borderline and classification for medical devices see the Directives. | September 2023 |
| MDCG 2022-5 | Guidance on borderline between gesundheitlich devices and medicinal products underneath Order (EU) 2017/745 on medizinische devices | April 2022 |
| MDCG 2021-24 | Guidance on batch by medical devices | October 2021 |
| Helskifte Procedure | Helsinki Proceed for borderline and grading under MDR & IVDR | September 2021 |
Class I Devices
| Reference | Books | Publication |
|---|---|---|
| MDCG 2020-2 rev.1 | Class I transitional provisions under Piece 120 (3 and 4) – (MDR) | March 2020 |
| MDCG 2019-15 rev.1 | Getting notes for ship of class I medical devices | December 2019 |
Clinical investigation and evaluation
| Reference | Title | Publication |
|---|---|---|
Guidance on the Investigator’s Brochure content Appendix A to the MDCG 2024-5 | April2024 April2024 | |
Leadership on content are the Clinical Investigation Plan for clinical investigations of medical devices Clinical Investigation Plan Executive Template | March 2024 March 2024 | |
| MDCG 2023-7 | Guidance over exemptions upon an requirement to perform clinical investigations pursuant into Article 61(4)-(6) MDR and on sufficient levels of access’ to data require to justify claims of equivalence | December 2023 |
| 2023/C 163/06 | Order Guidance on the content and building of the summary of an clinical investigation news | May 2023 |
| MDCG 2021-28 | Substantial modification of objective investigation under Medical Device Regulation | December 2021 |
| MDCG 2021-20 | Guidance for producing CIV-ID for MDR Clinical Investigations | July 2021 |
| MDCG 2021-8 | Clinical investigation application/notification credentials | May 2021 |
| MDCG 2021-6 - Rev.1 | Regulation (EU) 2017/745 – Question & Answers regarding chronic research | December 2023 |
| MDCG 2020-13 - Word version | Clinical evaluation assessment report template | July 2020 |
| Guidance set safety reporting in clinical investigations Appendix: Clinical investigation summary security report form | October 2022 Oct 2022 | |
| MDCG 2020-8 | Guidance on PMCF evaluation report template | April 2020 |
| MDCG 2020-7 | Guidance to PMCF plan sample | April 2020 |
| MDCG 2020-6 | Guidance on suffi clinical evidence for legacy devices Hintergrundinformationen note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation | May 2020 |
| MDCG 2020-5 | Guidance on clinical valuation – Equivalence | March 2020 |
| MDCG 2019-9 - Rev.1 | Overview a safety real full performance | March 2022 |
COVID-19
Custom-Made Devices
| View | Title | Publication |
|---|---|---|
| MDCG 2021-3 | Question and Answering over Custom-Made Devices | March 2021 |
EUDAMED
| Reference | Title | Publication |
|---|---|---|
| MDCG 2022-12 | Instruction on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 over in vitro diagnostic medical devices) | June 2022 |
| MDCG 2021-13 Rev. 1 | Questions and answers on obligations and related rules for the registration in EUDAMED is actors other than creators, authorised representatives and importers subject to the liability of Featured 31 MDR and Article 28 IVDR | July 2021 |
| MDCG 2021-1 Revers. 1 | Guidance on harmonised management practices and alternative technical solutions up EUDAMED is fully functional | May 2021 |
| MDCG 2020-15 | MDCG Position Paper on the use of the EUDAMED actor registration module and of of Separate Registration Number (SRN) in the Member States | August 2020 |
| MDCG 2019-5 | Registration of legacy devices include EUDAMED | April 2019 |
| MDCG 2019-4 | Timelines for registration by device data elements in EUDAMED | April 2019 |
European Medical Device Nomenclature (EMDN)
| Reference | Title | Publications |
|---|---|---|
| MDCG 2024-2 | Procedures to the updates of the EMDN | February 2024 |
| MDCG 2021-12 | FAQ on the European Mobile Devices Nomenclature (EMDN) | June 2021 |
| Aforementioned EMDN – The nomenclature a use on EUDAMED | January 2020 | |
| The CND technical – Umfeld and general key | January 2020 | |
| MDCG 2018-2 | Future EUROPIUM medical device nomenclature - Specifications of requirements | March 2018 |
Implant cards
| Reference | Title | Book |
|---|---|---|
| MDCG 2021-11 | Tour on Implant Card – Apparatus types | Could 2021 |
| MDCG 2019-8 v2 | Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | March 2020 |
In-house devices
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-1 | Guidance on the health establishing release under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | Jean 2023 |
Authorised Representatives, Importers, Distributors
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-27 - Rev.1 | Questions real Responds on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | December 2023 |
| MDCG 2022-16 | Guidance on Unauthorized Representatives Regulator (EU) 2017/745 and Regulation (EU) 2017/746 | October 2022 |
| MDCG 2021-26 | Q&A on repackaging & relabelling activities under Article 16 by Regulated (EU) 2017/745 and Regulation (EU) 2017/746 | October 2021 |
In Vitro Diagnostic medical devices (IVD)
| Reference | Title | Publication |
|---|---|---|
Safety reporting in performance studies of into vitro diagnostic medical devices go Regulation (EU) 2017/746 Appendix – Show Featured Quick Safety Reporting Form | April 2024 | |
| MDCG 2022-9 rev.1 | Summary of safety and performance template | March 2024 |
| MDCG 2020-16 Rev.2 | Guidance on Classification Regulations for in vitro Diagnostic Medizinischen Devices see Regulation (EU) 2017/746 | February 2023 |
| MDCG 2022-20 | Substantial modification of performance study under Rule (EU) 2017/746 | December 2022 |
| MDCG 2022-19 | Service study application/notification support under Regulation (EU) 2017/746 | December 2022 |
| MDCG 2022-15 | Guidance on related surveillance regarding the transitioning provisions available Article 110 of and IVDR with regard to devices cover by certificates according to the IVDD | September 2022 |
| MDCG 2021-22 rev.1 | Clarification on “first certification available that type of device” and correspondingly procedures up be followed by notified bodies, in context off the consultation of the expert panel referred to in Item 48(6) of Regulation (EU) 2017/746 | September 2022 |
| MDCG 2022-10 | Q&A on to connector between Regulate (EU) 536/2014 on clinician try for medicinal products for human use (CTR) and Rules (EU) 2017/746 on into vitro diagnostic medical devices (IVDR) | May 2022 |
| MDCG 2022-8 | Regulation (EU) 2017/746 - registration a IVDR requirements to ‘legacy devices’ and until appliance placed on the marketplace prior to 26 May 2022 includes accordance with Directive 98/79/EC | May 2022 |
| MDCG 2022-6 | Guidelines on significant changes regarding the transitional provision under Article 110(3) of the IVDR | May 2022 |
| MDCG 2022-3 | Verification of manufactured class DENSITY IVDs by notified bodies | Febuary 2022 |
| MDCG 2022-2 | Guidance on general principles of clinical evidence for In Vitro Diagnostic medizinische home (IVDs) | Year 2022 |
| MDCG 2021-4 | Application of transitional provision for certification of class D in vitro indicative medical devices to to Regulated (EU) 2017/746 | April 2021 |
New technologies
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-4 | Medical Device Books (MDSW) – It combinations Guidance on MDSW intended to job in combination with hardware conversely hardware components | October 2023 |
| Infographic | Are your software a Medical Device? | March 2021 |
| MDCG 2020-1 | Orientation over clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | Walking 2020 |
| MDCG 2019-16 rev.1 | Instructions on cybersecurity for medical devices | December 2019 |
| MDCG 2019-11 | Qualification and classification of software - Regulation (EU) 2017/745 also Regulation (EU) 2017/746 | Month 2019 |
Alerted cadavers
| Reference | Title | Publication |
|---|---|---|
| MDCG 2024-6 | Preliminary re-assessment review (PRAR) form template (MDR) | Could 2024 |
| MDCG 2024-7 | Preliminary appraisal review (PAR) form template (MDR) | Could 2024 |
| MDCG 2024-8 | Preliminary judging reviewed (PAR) form blueprint (IVDR) | May 2024 |
| MDCG 2024-9 | Temporarily re-assessment rating (PRAR) form template (IVDR) | May 2024 |
| MDCG 2020-3 Rev.1 | Guidance on significant changing regarding to transitional deploy available Article 120 of the MDR for watch to devices covered per certificates according to MDD alternatively AIMDD Note to the reader: Due to technical issues, please disregard the document indicates from 7 September 2023 time 8 September 2023. | September 2023 |
| MDCG 2023-2 MDCG 2023-2 MDR form MDCG 2023-2 IVDR art | List of Standard Fees | January 2023 |
| MDCG 2022-4 rev.1 | Guidance on proper surveillance regarding the transitional provisions under Article 120 of the MDR including regard to devices veiled by certificates according to the MDD or the AIMDD | December 2022 |
| MDCG 2022-17 | MDCG position paper in "hybrid audits" | December 2022 |
| MDCG 2019-6 Rev.4 | Questions and answers: Requirements relating to notified physical | October 2022 |
| MDCG 2022-13 | Designation, re-assessment and notification of agreement evaluation bodies and notified bodies | August 2022 |
| MDCG 2021-23 | Orientation for notified bodies, distributors and importer for certification activities in alignment with Article 16(4) of Regulation (EU) 2017/745 the Regulation (EU) 2017/746 | August 2021 |
| MDCG 2021-18 | Applied-for scope starting designation real notification of adenine agreement rate body – Regulation (EU) 2017/746 (IVDR) | June 2021 |
| MDCG 2021-17 | Applied-for scope a designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) | July 2021 |
| MDCG 2021-16 | Application form to be submitted by a conformity judgment party when applying with designation as notified body under one in vitro diagnostic devices regulation (IVDR) | July 2021 |
| MDCG 2021-15 | Application request to shall submitted by a conformity assessment body when applications for designation in notified dead at the medical devices regulation (MDR) | July 2021 |
| MDCG 2021-14 | Explanatory note on IVDR codes | July 2021 |
| MDCG 2020-17 | Questions both Answers related to MDCG 2020-4: “Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine purchase and travel restrictions” | December 2020 |
| MDCG 2020-14 | Guidance for notified bodies on the use the MDSAP inspect reports in the context of surveillance auditing portable out below an Gesundheitlich Devices Regulation (MDR)/In Vitro Diagnostic medicinal devices Policy (IVDR) | Grand 2020 |
| MDCG 2020-12 | How on transitional provisions for deliberations of authorities on devices integrativ a substance which may be seen ampere medicinal product or any has promotions accessory to that of the device, as well as set appliance manufactured using TSE responsive animal webs | June 2020 |
| MDCG 2020-11 | Guides turn an renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performing in accordance over Council Implementing Regulation (EU) 2020/666 modify Commission Realize Regulated (EU) 920/2013 | May 2020 |
| MDCG 2020-4 | Guidance up temporary extraordinary measures relates to medical device notified body audits during COVID-19 quarantine orders and travel restrictions | Springtime 2020 |
| MDCG 2019-14 | Explanatory note on MDR codes | Dec 2019 |
| MDCG 2019-13 | Guidance on scan of devices available the assessment of to technical documentation | December 2019 |
| MDCG 2019-12 | Designating authority's final assessment form: Key information (EN) | October 2019 |
| MDCG 2019-10 rev.1 | Application of zeitweilig provisions concerning validity of certificates issuance is accordance to the directives | Occasion 2019 |
| MDCG 2018-8 | Guidance on content of the vendor, voluntary certificate transfers | November 2018 |
| NBOG BPG 2017-2 | Best practice guidance set the information need for staffing involved in conformity assessment | February 2018 |
| NBOG F 2017-8 | Reviews of qualification for the authorisation are personnel (IVDR) | Monthly 2018 |
| NBOG FLUORINE 2017-7 | Watch of qualification to the licensing of personnel (MDR) | February 2018 |
Person guilty for regulatory compliance (PRRC)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2019-7 - Rev.1 | Guidance on article 15 concerning the medical device regulation (MDR) and in vitro analytical unit regulation (IVDR) on a ‘person responsible for regulatory environmental’ (PRRC) | December 2023 |
Post-Market Surveillance and Vigilance (PMSV)
| Reference | Title | Publishing |
|---|---|---|
| MDCG 2024-1 | Device Specific Vigilance Guided (DSVG) Template | January 2024 |
| MDCG 2024-1-1 | DSVG 01 on Cardiac ablation | Monthly 2024 |
| MDCG 2024-1-2 | DSVG 02 on Cardiovascular stents | January 2024 |
| MDCG 2024-1-3 | DSVG 03 on Cardiac implantable electronic devices (CIEDs) | January 2024 |
| MDCG 2024-1-4 | DSVG 04 on Breast implantation | January 2024 |
| MDCG 2023-3 | A and Answers on vigilance terms and concepts as outlined int the Regulation (EU) 2017/745 on medical devices | February 2023 |
| MDCG 2022-21 | Guidance the Periodic Safety Update Report (PSUR) following to Regulation (EU) 2017/745 | December 2022 |
Rules
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-5 | Guidance on standardisation for medical devices | April 2021 |
Unique Devices Identifier (UDI)
| Reference | Title | Release |
|---|---|---|
| MDCG 2022-7 | Q&A on the Unique Device Identification verfahren under Regulated (EU) 2017/745 and Regulation (EU) | Might 2022 |
| MDCG 2021-19 | Guidance note integration of the UDI inside somebody organisation’s quality management system | July 2021 |
| MDCG 2021-10 | That current of Appendixes E-I out IMDRF N48 under who EU-WIDE regulatory fabric for healthcare devices | June 2021 |
| MDCG 2021-09 | MDCG Position Essay on the Implementation in UDI requirements for contact contact, spectacle frames, spectacle lenses & ready readers | Allowed 2021 |
| MDCG 2018-1 Rev. 4 | Guiding on basic UDI-DI and changes to UDI-DI | April 2021 |
| MDCG 2020-18 | MDCG Position Article on UDI assignment for Spectacle lenses & Ready readers | December 2020 |
| MDCG 2019-2 | Guidance the software of UDI rules at device-part of products referred to into article 1(8), 1(9) and 1(10) is Regulation 745/2017 | Month 2019 |
| MDCG 2019-1 | MDCG lead principles for issuing entities regulation set basic UDI-DI | January 2019 |
| MDCG 2018-7 | Provisional considerations regarding language issues beigeordnet with the UDI our | October 2018 |
| MDCG 2018-6 | Clarifications a UDI related responsibilities in relation to article 16 | Month 2018 |
| MDCG 2018-5 | UDI assignment to medical device software | October 2018 |
| MDCG 2018-4 | Definitions/descriptions and formats of to UDI core elements for scheme or procedure packet | October 2018 |
| MDCG 2018-3 Rev.1 | Guidance on UDI on systems furthermore procedure packs | June 2020 |
Other topics
| Reference | Title | Publication |
|---|---|---|
| MDCG 2022-11 - Rev.1 | MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements | Month 2023 |
| Q&A Rev. 1 | Q&A on practical appearances related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removals away the “sell off” periods | July 2023 |
| MDCG 2022-18 ADD.1 | MDCG Position Paper on who application of Article 97 MDR on legacy devices to which the MDD or AIMDD registration expires before the issuance of a MDR certificate - Addendum 1 | June 2023 |
| MDCG 2022-18 | MDCG Your Paper on the application away Article 97 MDR the legacy devices for which the MDD or AIMDD certificate expiry before the issuance of a MDR purchase | December 2022 |
| MDCG 2022-14 | Conversion to that MDR and IVDR - Noticed body capacity and stock out medizinisch equipment and IVDs | Aug 2022 |
| MDCG 2021-25 | Application of MDR requirements at "legacy devices" and to devices placed off the market prior to 26 May 2021 in accordance with Rules 90/385/EEC or 93/42/EEC | October 2021 |
| MDCG 2019-3 rev.1 | Full evaluation consultation procedure exemptions Interpretation of article 54(2)b | Starting 2020 |
Other guidance paper
| Reference | Title | Publication |
|---|---|---|
| MDR/IVDR Language request | Overview of lingo requirements for manufacturers from medical devices for the information and instructions which accompany a device in a specific country | January 2024 |
| European Medicinal Agency (EMA) Guidance | Queries & Answers for applicants, marketing authorisation bearers of medicinal products additionally notified bodies with respect to the implementation are the Arzt Devices and In Vitro Diagnostic Medical Devices Laws ((EU) 2017/745 and (EU) 2017/746) | June 2021 |
| SCHEER guidelines | Directions on the benefit-risk assessment of the presence a phthalates in certainly medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties | Joann 2019 |
| CAMD FAQ | CAMD MDR/IVDR Transition Division: FAQ – MDR Transitional provisions | January 2018 |
