GMDN Agency: Training and Q&A Workshops Scheduled for Manufacturers and Regulators
June 11, 2024
Switzerland ‘swissdamed’ Actor Registration Module: Go-live Scheduled for August 2024
June 26, 2024Table of Contents
In March the MDCG released its (non-exhaustive) list of updated ‘Ongoing/planned guidance and deliverables of MDCG Subgroups’. It is available: HERE
Below we provide a status update: what’s been released (italicized items) and what’s still pending completion.
MDR & IVDR
| Group Deliverables | Consult prior to MDCG** | Planned MDCG Endorsement | Status |
| Notified Bodies Oversight (NBO) | |||
| Update of best practice guidance on designation and notification (MDCG 2022-13), including extension of scope | NBCG-med | Q2 2024 | Ongoing |
| Revision of NBOG F 2017-5 and -6 (PAR forms) | NBCG-med | Q2 2024 | Ongoing |
| PAR forms for re-assessment | NBCG-med | Q2 2024 | Ongoing |
| Corrective and Preventative Action plan (form) | NBCG-med | Q2 2024 | Ongoing |
| Update of best practice guidance on the information required for the conformity assessment bodies’ personnel involved in conformity assessment activities (NBOG BPG 2017-2) | NBCG-med | 2024 | Ongoing |
| Revision of MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation | MDCG Stakeholders and relevant MDCG subgroups | 2024 | Ongoing |
| Q&A on requirements notified bodies – update of MDCG 2019-6 | NBCG-Med and all MDCG stakeholders as needed | 2024 | Permanent NBO Work Item – ongoing |
| Standards | |||
| Extension and improvement of the MDCG guidance document on standardisation for medical devices endorsed and published in April 2021 (MDCG 2021-5) | TBD | Q2 2024 | Ongoing |
| Post-Market Surveillance and Vigilance (PMSV) | |||
| DSVG for transvaginal urogynaecological surgical mesh implants | N/A | Q1 2024 | Ongoing |
| Update MIR form, MIR PDF file, MIR Help text and related documents | IVD | Q2 2024 | Ongoing |
| Revision of MIR Q&A document | IVD | Q2 2024 | Ongoing |
| Guidance on Post-Market Surveillance | MS/IVD | Q2 2024 | Ongoing |
| Revision of Trend report and related documents | MS/IVD | Q2 2024 | Ongoing |
| Revision of Field Safety Corrective Action form | IVD | Q3 2024 | Ongoing |
| Market Surveillance (MS) | |||
| Guidance document for manufacturers of custom made & adaptable devices | NTE | TBD | Postponed until 2025 |
| Borderline & Classification (B&C) | |||
| Participate in Helsinki procedure and publish the B&C manual | IVD, NT | Continuous | Ongoing |
| Procedures for notification of decision on dispute | IVD | Q4 2024 | Ongoing |
| New Technologies | |||
| Legal status of app providers | MS | Q4 2024 | Ongoing |
| Targeted revision of MDCG 2019-11 | B&C | Q4 2024 | Ongoing |
| FAQ on Interplay between MDR/IVDR and AIA | As relevant | Q4 2024 | To be launched |
| Nomenclature | |||
| FAQ on EMDN | N/A | Q3 2024 | Ongoing |
| Tool for EMDN definitions | N/A | 2025 | Ongoing |
**Stakeholders are observers in 11 MDCG subgroups and are consulted on a regular basis; further to that other MDCG subgroups are consulted as indicated.
MDR Only
| Group Deliverables | Consult prior to MDCG** | Planned MDCG Endorsement | Status |
| Notified Bodies Oversight (NBO) | |||
| Guidance on “appropriate surveillance” according to Article 120 (3) MDR | MDCG Stakeholders and MS | Q2 2024 | Ongoing |
| Notified Body Technical Documentation Assessment Report | Notified bodies and relevant MDCG Subgroups | 2024 PSUR section to be delivered as a first step | Ongoing |
| Clinical Investigations and Evaluation (CIE) | |||
| Contingency approach to exchange information according to Article 76(3) MDR in absence of EUDAMED | N/A | As needed | Ongoing |
| Guidance on content of Investigator’s Brochure for clinical investigations conducted under (EU) regulation 2017/745 (MDR) | N/A | Q1 2024 | Ongoing |
| Update of the MDCG 2019-9 – Rev.1 Summary of safety and clinical performance | N/A | Q1 2024 | Ongoing |
| Update of the clinical evaluation guidance | N/A | Q3 2024 | Ongoing |
| Clinical investigation – Q&A document | N/A | End 2024 | Ongoing |
| Post-Market Surveillance and Vigilance (PMSV) | |||
| MDR Vigilance guidance on implementation of Articles 87 to 90 MDR | MS /IVD | Q2 2024 | Ongoing |
| Borderline & Classification (B&C) | |||
| Exploratory paper on qualification of products specifically intended for the cleaning, disinfection or sterilisation of devices | N/A | Q2 2024 | Ongoing |
| Minor revision of classification guidance MDCG 2021-24 | N/A | Q3 2024 | Ongoing |
| Unique Device Identification (UDI) | |||
| Guidance on Master UDI-DI | UDI | Q2 2024 | Ongoing |
| Other | |||
| Guidance on certificates under conditions | NBO and CIE | 2024 | Ongoing – Task Force established under MDCG |
| Guidance for manufacturers and notified bodies on the application of clinical evaluation requirements to orphan devices in view of their certification in accordance with the MDR | NBO, CIE, stakeholders of orphan device taskforce | 2024 | Ongoing – Task Force established under MDCG |
| Revision of MDCG 2021-25 ‘Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC | NBO, MS, PMSV, MDCG stakeholders | 2024 | Ongoing – Task Force established under MDCG |
**Stakeholders are observers in 11 MDCG subgroups and are consulted on a regular basis; further to that other MDCG subgroups are consulted as indicated.
IVDR Only
| Group Deliverables | Consult prior to MDCG** | Planned MDCG Endorsement | Status |
| Notified Bodies Oversight (NBO) | |||
| Minor revision of MDCG 2021-14 | NBCG-Med, MDCG Stakeholders and IVD | 2024 | Ongoing |
| Post-Market Surveillance and Vigilance (PMSV) | |||
| Extension of Q&A documents on Vigilance terms and concepts to IVDR requirements | IVD, NBO | Q2 2024 | Ongoing |
| Extension of PSUR guidance IVDR | IVD, MS, NBO | Q3 2024 | Ongoing |
| In Vitro Diagnostic Medical Devices (IVD) | |||
| Minor revision of MDCG 2020-16 | B&C | Q1 2024 | Ongoing |
| Guidance on IVD borderline issues | B&C | Q1 2024 | Ongoing |
| Common specifications for hepatitis E, Plasmodium, Toxoplasma and arboviruses | N/A | Q2 2024 | Ongoing |
| Q&A/guidance on distance sales | Joint with MSWG | Q3 2024 | Ongoing |
| Guidance on Research Use Only devices | N/A | Q4 2024 | Ongoing |
| Minor revision of MDCG 2023-1 – Health institution exemption (definition of ‘health institution’) | MSG | Q4 2024 | Ongoing |
| Template and guidance for safety reporting in performance studies under IVDR | CIE | 2024 | Ongoing |
| Questions and Answers document on performance studies | CIE | 2024 | Ongoing |
| Analysis of IVDR in context of hypothetical scenarios of an urgent response to a health crisis | N/A | 2024 | Ongoing |
| Minor revision of MDCG 2021-14 – Explanatory note on IVDR codes | NBO | 2024 | Ongoing |
**Stakeholders are observers in 11 MDCG subgroups and are consulted on a regular basis; further to that other MDCG subgroups are consulted as indicated.
Further Reading
The following topics may also be of interest:
