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Regulatory Affairs News

20.06.2024

European Commission

Updated MDCG 2022-13 (rev.1) on the designation, re-assessment and notification of NBs. The changes include:

  • Guidance on the conduct of joint assessments relating to extending the scope of designations
  • Revised Section 4.4 to Decision on granting the extension of the scope of designation
  • New section 5 Changes to a NB’s designation other than extension of its scope.
  • New section 6 Re-assessments of NBs.

 

SCHEER updated guidelines on phthalates published on 14-Jun-2024.

  • Referring to new guideline documents
  • Adapting recent regulatory developments
  • Extended annexes (Annex 8, 9, 10)

 

Swissmedic

Swissmedic updated its Guidance document on Incident economic operators v3.3, with the following changes:

  • Explicitly indicated that guidance document MDCG 2023-3 on Vigilance applies also in Switzerland and that, by analogy, the requirements also apply to IVDs.
  • Restructured section 9 on the reporting procedure so that subsection 9.1 corresponds to MIR, and added section 9.1.1 on the investigation by the manufacturer or System and Procedure Pack Producer (SPPP).
  • Restructured section 10 on the reports from end users that are forwarded to the manufacturer/SPPP by Swissmedic. Added subsection 10.2 on Swissmedic’s expectations on the manufacturer/SPPP justification of why the incident is not reportable.
13.06.2024

European Commission

Published MDCG 2024-1-5 Device-specific Vigilance Guidance (DVSG) no. 05 on Urogynaecological Surgical Mesh Implants: Guidance for manufacturers on reporting device-specific serious incidents, trend reports, and periodic summary reports for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.

 

Swissmedic

The below-amended ordinances relating to the Human Research Act (HRA, SR 810.30) were approved by the Swiss Federal Council on 7 June 2024 and shall apply as of 1 November 2024, except the provisions on transparency, which enter into force on 1 March 2025. These ordinances concern human research conducted in Switzerland.

  • Clinical Trials Ordinance (ClinO, SR 810.305)
  • Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306)
  • Human Research Ordinance (HRO, SR 810.301)
  • HRA Organisation Ordinance (OrgO-HRA, SR 810.308)

 

Swissmedic’s annual report for 2023:

  • General information on Medicinal Products in Switzerland
  • General information on Medical Devices in Switzerland
06.06.2024

Swissmedic

Updated Information Sheet on Clinical investigations with medical devices v4.4

  • Annex 2 updated according to MDCG 2024-3

Updated Information Sheet on Performance studies with IVD v3.5

  • MDCG 2020-10 replaced by MDCG 2024-4
  • Annex A2 updated according to MDCG 2024-3.

 

European Commission

Publication of the Implementing Decision C(2024)3371 amending Implementing Decision C(2021) 2406 on a standardisation request for Electrotechnical Standardization.

The details of what is being amended are described in Annexes I through III and include:

  • the lists of Harmonised Standards (HS) under the EU MDR and IVDR to be reviewed or drafted by CEN/CENELEC, and the corresponding deadlines,
  • some additions/modifications to the requirements for certain standards, e.g. the request for a new EU-REP symbol (instead of EC-REP) in EN ISO 15223-1.
20.06.2024

European Commission

Updated MDCG 2022-13 (rev.1) on the designation, re-assessment and notification of NBs. The changes include:

  • Guidance on the conduct of joint assessments relating to extending the scope of designations
  • Revised Section 4.4 to Decision on granting the extension of the scope of designation
  • New section 5 Changes to a NB’s designation other than extension of its scope.
  • New section 6 Re-assessments of NBs.

 

SCHEER updated guidelines on phthalates published on 14-Jun-2024.

  • Referring to new guideline documents
  • Adapting recent regulatory developments
  • Extended annexes (Annex 8, 9, 10)

 

Swissmedic

Swissmedic updated its Guidance document on Incident economic operators v3.3, with the following changes:

  • Explicitly indicated that guidance document MDCG 2023-3 on Vigilance applies also in Switzerland and that, by analogy, the requirements also apply to IVDs.
  • Restructured section 9 on the reporting procedure so that subsection 9.1 corresponds to MIR, and added section 9.1.1 on the investigation by the manufacturer or System and Procedure Pack Producer (SPPP).
  • Restructured section 10 on the reports from end users that are forwarded to the manufacturer/SPPP by Swissmedic. Added subsection 10.2 on Swissmedic’s expectations on the manufacturer/SPPP justification of why the incident is not reportable.
13.06.2024

European Commission

Published MDCG 2024-1-5 Device-specific Vigilance Guidance (DVSG) no. 05 on Urogynaecological Surgical Mesh Implants: Guidance for manufacturers on reporting device-specific serious incidents, trend reports, and periodic summary reports for Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence.

 

Swissmedic

The below-amended ordinances relating to the Human Research Act (HRA, SR 810.30) were approved by the Swiss Federal Council on 7 June 2024 and shall apply as of 1 November 2024, except the provisions on transparency, which enter into force on 1 March 2025. These ordinances concern human research conducted in Switzerland.

  • Clinical Trials Ordinance (ClinO, SR 810.305)
  • Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306)
  • Human Research Ordinance (HRO, SR 810.301)
  • HRA Organisation Ordinance (OrgO-HRA, SR 810.308)

 

Swissmedic’s annual report for 2023:

  • General information on Medicinal Products in Switzerland
  • General information on Medical Devices in Switzerland

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