Now that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance documents of the MDCG Subgroups.
Several new guidance documents have been added, related to topics such as standardisation process, artificial intelligence or Market Surveillance. Interestingly, a guidance for COVID-19 antibody tests is also in the works and it is scheduled to be endorsed before the end of the year. On the other hand, certain guidance documents have been postponed, even though most the established plan has been maintained.
You can find a summary of all the changes in the tables below.
NEW GUIDANCE
| Category | Name | Planned MDCG Endorsement |
| Notified Bodies | Q&A related to MDCG 2020-4 | 2020 |
| Updates of guidance documents and templates on the designation and re-assessment process | 2021 | |
| Updates of guidance documents and templates on qualification and authorisation of personnel | 2021 | |
| Guidance on Certifications according to Article 16 MDR/IVDR | 2021 | |
| Guidance on appropriate surveillance according to Article 120(3) | 2021 | |
| Guidance on NB opinions on the conformity of the device part according to Article 117 MDR | TBD | |
| Explanatory note on codes | Q1 2021 | |
| Standards | MDR/IVDR Standardisation Request | 2021 |
| Guidance on standardisation in the medical devices field | 2020 | |
| Clinical Investigations and Evaluation | Q&A on clinical investigation | 2020 |
| Market Surveillance | Guidelines on Re-labelling & Re-packaging | 2020 |
| Q&A on Custom-Made & Adaptable Devices | 2020 | |
| New Technologies | Legal status of app providers | 2020 |
| Artificial Intelligence under MDR/IVDR framework | TBD | |
| Eudamed | Guidance on harmonised administrative practices and alternative technical solutions | 2020 |
| IVD | Guidance on state of the art for COVID-19 antibody tests | 2020 |
| Q&A on IVDs in context of COVID-19 | 2020 | |
| Nomenclature | Rules for allocation of EMDN to UDI-DI | Q1 2021 |
| Procedures for the annual and ad-hoc updates of EMDN | Q1 2021 |
CHANGES ON ENDORSEMENT DATE
| Category | Name | Planned MDCG Endorsement |
| Notified Bodies | Batch verification on class D IVDs | Q1 2021 (from TBD) |
| Guidance on clinical evaluation consultation procedure | 2021 (from TBD) | |
| Borderline & Classification | Borderline with medicinal products (including general guidance, definitions of pharmacological, immunological and metabolic means of action and diagnosis) | 2021 (from TBD) |
| Classification of medical devices NBO / NET 2020 | 2020 (from TBD) | |
| Unique Device Identification | Integration of UDI in manufacturers’ QMS | 2020 (from 2019) |
| Guidelines on specific product types (contact lenses) | 2020 (from 2019) | |
| International matters | Taking into account MDSAP for NB | 2020 (from TBD) |
| IVD | Classification of IVDs | 2020 (from 2019) |
| Performance evaluation | 2021 (from TBD) | |
| Transfer of Common Technical Specifications (IVDD) to Common Specifications (IVDR) | 2021 (from TBD) | |
| Nomenclature | Rules and process for update of EMDN | 2020 (from 2019) |
| 1st release of EMDN | Q4 2020 (from TBD) | |
| List of EMDN terms to be used for implant card purposes | 2021 (from 2019) | |
| Annex XVI | Qualification of devices listed in Annex XVI | 2021 (from TBD) |
Asphalion, an International Scientific and Regulatory Affairs Consultancy with extensive knowledge on medical devices, closely monitors every new and movement around the new MDR and IVDR in order to be able to better advise and guide manufacturers and stakeholders on their implementation. If you have any questions do not hesitate to contact us at: [email protected]
