Updates on the Ongoing guidance development within MDCG Subgroups

Updates on the Ongoing guidance development within MDCG Subgroups

Now that the year is about to come to an end, the EC 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.

Now that the year is about to come to an end, the EC 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.
October 29, 2020

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

CategoryNamePlanned MDCG Endorsement
Notified BodiesQ&A related to MDCG 2020-42020
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 codesQ1 2021
StandardsMDR/IVDR Standardisation Request2021
Guidance on standardisation in the medical

devices field

2020
Clinical Investigations and EvaluationQ&A on clinical investigation2020
Market SurveillanceGuidelines on Re-labelling & Re-packaging2020
Q&A on Custom-Made & Adaptable Devices2020
New TechnologiesLegal status of app providers2020
Artificial Intelligence under MDR/IVDR

framework

TBD
EudamedGuidance on harmonised administrative practices

and alternative technical solutions

2020
IVDGuidance on state of the art for COVID-19

antibody tests

2020
Q&A on IVDs in context of COVID-192020
NomenclatureRules for allocation of EMDN to UDI-DIQ1 2021
Procedures for the annual and ad-hoc updates of

EMDN

Q1 2021

 

CHANGES ON ENDORSEMENT DATE

CategoryNamePlanned MDCG Endorsement
Notified BodiesBatch verification on class D IVDsQ1 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 20202020 (from TBD)
Unique Device IdentificationIntegration of UDI in manufacturers’ QMS2020 (from 2019)
Guidelines on specific product types (contact

lenses)

2020 (from 2019)
International mattersTaking into account MDSAP for NB2020 (from TBD)
IVDClassification of IVDs2020 (from 2019)
Performance evaluation2021 (from TBD)
Transfer of Common Technical Specifications

(IVDD) to Common Specifications (IVDR)

2021 (from TBD)
NomenclatureRules and process for update of EMDN2020 (from 2019)
1st release of EMDNQ4 2020 (from TBD)
List of EMDN terms to be used for implant card

purposes

2021 (from 2019)
Annex XVIQualification of devices listed in Annex XVI2021 (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]

 

 

 

 

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