Decomplix

👉🏼 Regulatory news 𝗦𝘄𝗶𝘀𝘀𝗺𝗲𝗱𝗶𝗰 Swissmedic updated its Guidance document on Incident economic operators v3.3 (https://lnkd.in/dPhZemTz), 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. 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MedDO #IvDO #RegulatoryAffairs #Switzerland #SwissMedtech #Swissmedic #Decomplix

👉🏼 Regulatory news 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻   Updated MDCG 2022-13 (rev.1) on the designation, re-assessment and notification of NBs (https://lnkd.in/e3Wcf5Ad). 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 (https://lnkd.in/dQ8khBuQ). ● Referring to new guideline documents ● Adapting recent regulatory developments ● Extended annexes (Annex 8, 9, 10) 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MDR #IVDR #MDCG #RegulatoryAffairs #MedicalDevices #EU #Decomplix

👉🏼 Regulatory news 𝗦𝘄𝗶𝘀𝘀𝗺𝗲𝗱𝗶𝗰 The below-amended ordinances relating to the Human Research Act (HRA, SR 810.30; https://lnkd.in/d9gyw9Qn) 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 (https://lnkd.in/dNRVtn8r): ● General information on Medicinal Products in Switzerland ● General information on Medical Devices in Switzerland 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MedDO #IvDO #RegulatoryAffairs #Switzerland #SwissMedtech #Swissmedic #Decomplix

👉🏼 Regulatory news 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻   Published MDCG 2024-1-5 Device-specific Vigilance Guidance (DVSG) no. 05 on Urogynaecological Surgical Mesh Implants (https://lnkd.in/dmRiRj2G): 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. 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MDR #IVDR #RegulatoryAffairs #EU #Decomplix

👉🏼 Regulatory news 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻   Publication of the Implementing Decision C(2024)3371 (https://lnkd.in/ekyxn9ux) 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 (https://lnkd.in/eTqxA9S8) 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. 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MDR #IVDR #RegulatoryAffairs #EU #Decomplix

👉🏼 Regulatory news 𝗦𝘄𝗶𝘀𝘀𝗺𝗲𝗱𝗶𝗰 Updated Information Sheet on Clinical investigations with medical devices v4.4 (https://lnkd.in/eh-VRXSE) ▶ Annex 2 updated according to MDCG 2024-3   Updated Information Sheet on Performance studies with IVD v3.5 (https://lnkd.in/exkPiuew) ▶ MDCG 2020-10 replaced by MDCG 2024-4 ▶ Annex A2 updated according to MDCG 2024-3. 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MedDO #IvDO #RegulatoryAffairs #Switzerland #SwissMedtech #Swissmedic #Decomplix

Are you part of the medical device industry? Are you curious about whether you need a quality management system certification according to the ISO 13485 standard? Read our updated blog article. #medtech #legal #consulting #eumdr #iso13485 #ivdr Swiss Medtech sitem-insel https://lnkd.in/eJ7AmZ9y for regular updates around regulation of medical devices.

👉🏼 Regulatory news 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻 MDCG 2022-4 rev.2: Guidance on appropriate surveillance of transitional provisions per EU MDR Art. 120 (https://lnkd.in/dm3T9Aq3) This guidance document concerns the Notified Body which continues carrying on the surveillance of “legacy” devices until the end of the applicable transitional period in the EU MDR. The new revision introduces adjustments all over the document to align with Reg. (EU) 2023/607 regarding the new transitional provisions. 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MDR #IVDR #RegulatoryAffairs #EU #MDCG #Decomplix

"Why build a marketplace for medical algorithms and clinical decision support tools?" We asked 7 questions to Evidencio CEO Rob Mentink about their medical algorithm platform: https://lnkd.in/ekzyUQBh sitem-insel Sitem StartUp Club (SSC) Swiss Medtech Tom Hueting Rick Pleijhuis Andreas R. Müller Hansjörg Riedwyl #MDSW #Algorithms #AI #FastTrack #LegalManufacturer #MDR #CEMarking

👉🏼 Regulatory news 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗼𝗺𝗺𝗶𝘀𝘀𝗶𝗼𝗻 4 new MDCG templates have been published, for the assessment and re-assessment of Notified Bodies by the corresponding Designating Authority: ●     MDCG 2024-6 on the preliminary re-assessment under the EU MDR (https://lnkd.in/eEj76Rv9) ●     MDCG 2024-7 on the preliminary assessment under the EU MDR (https://lnkd.in/eDc_dUyb) ●     MDCG 2024-8 on the preliminary assessment under the IVDR (https://lnkd.in/e4HaiAZr) ●     MDCG 2024-9 on the preliminary re-assessment under the IVDR (https://lnkd.in/eVq7Kpwt) 👉🏼 More news on #medicaldevice #regulation from us: https://lnkd.in/eHs3khty #MDR #IVDR #RegulatoryAffairs #EU #MDCG #Decomplix