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Alban Gossé

8 Feb 2022 | The team

Engineer in Materials Engineering (EEIGM, INPL), I had the opportunity for fifteen years to occupy various functions in Research & Development of implantable medical devices and active medical devices. During these different experiences, I played a major role in...

MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) – January 2022

7 Feb 2022 | MDCG, MDCG

Theme Clinical evidence – Performance evaluation Target Audience Manufacturers, investigators and study sponsors, regulators, notified bodies and other stakeholders when considering clinical evidence Products concerned IVD Documents mentioned IVDR (EU) 2017/746...

MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices – January 2022

7 Feb 2022 | MDCG, MDCG

Theme Compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC or Regulation (EU) 2017/746. Target Audience Manufacturers of IVDs for the detection/quantification of markers of SARS-CoV-2 infection established outside the EU or EEA and intending to...

MDCG 2021-27 Rev.1 : Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – December 2021

7 Feb 2022 | All the News

Theme Obligations of distributors and importers Target Audience Importers and distributors Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2018-6 MDCG 2021-13 MDCG 2021-23 MDCG 2021-26 Regulation (EU) 2019/1020 : market...

MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation – December 2021

7 Feb 2022 | All the News

Theme Notification of a substantial modification of clinical investigation Target Audience Sponsor of a clinical investigation Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-8 MDCG 2021-20 The sponsor of a clinical investigation is required to...

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Alban Gossé

MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) – January 2022

MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices – January 2022

MDCG 2021-27 Rev.1 : Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – December 2021

MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation – December 2021

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Alban Gossé

MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) – January 2022

MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices – January 2022

MDCG 2021-27 Rev.1 : Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – December 2021

MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation – December 2021

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