Medical Devices Newsletter

Medical Devices Newsletter:

EU:

July 17, 2020:


MDCG 2020-13: The EU-Commission has updated the “Clinical evaluation assessment report template” – Link

June 29, 2020:


MDCG 2018-3 Rev.1: The EU-Commission has updated the “Guidance on UDI for systems and procedure packs” – Link

June 17, 2020:


  • TÜV SÜD (NB 0123) has received its designation under IVDR. Check their scope with the following – Link

June 10, 2020:


  • MDCG 2020-12: Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissue – Link

May 28, 2020:


  • MDCG 2020-11: Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 – Link

May 19, 2020:


  • EU-Commission: Guidelines on the adoption of union-wide derogations for medical devices in accordance with article 59 of regulation MDR (EU) 2017/745 – Link

May 15, 2020:


  • New Notified Body designated under MDR: Intertek Medical Notified Body AB – Link

May 14, 2020:


  • MDR EU 2017/745 consolidated text: MDR consolidated text (including corrigendum 1 and 2 + postponement until May 2021) – Link

May 13, 2020:


  • MDCG 2020-10/2: Clinical Investigation Summary Safety Report Form v1.0 – Link
  • MDCG 2020-10/1: Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 – Link
  • MDCG ongoing guidance development: Update May 2020 – Link

April 27, 2020:


  • MDCG 2020-9: Regulatory Requirements for Ventilators and Related Accessories – Link

April 25, 2020:


  • The Notified Body MDC is designated under MDR: Check their scope Link

April 24, 2020:


  • BREAKING NEWS: MDR officially postponed until May 26, 2021. Check  the published amendment – EN / DE / FR / IT / ES
  • MDCG 2020-8: Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies – Link
  • MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies – Link
  • MDCG 2020-6: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies – Link
  • MDCG 2020-5: Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies – Link

March 17, 2020:


  • MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD  – Link
  • MDCG 2020-2: Class l Transitional provisions under article 120 (3 and 4) – Link
  • MDCG 2020-1: Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software  – Link

March 16, 2020:


  • MDCG 2019-8 v2: Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices – Link
  • MDCG 2018-1 v3: Guidance on BASIC UDI-DI and changes to UDI-DI – Link

January 10, 2020:


  • Basis of EUDAMED nomoclature will be CND (Classificazione Nazionale Dispositivi medici) – Link
  • The CND Nomenclature – background and general principles – Link

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