Daily: snapshots/state/report [skip ci]

Author: reguwatch-bot

last_diff.txt

@@ -0,0 +1,383 @@
+# ReguWatch — Daily Summary
+Date (UTC): 2025-12-17
+
+## Changes today
+
+### Issue #3
+**Page:** [https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en)
+**Changes:** Text & Links
+
+**Full text diff:**
+```
+--- Issue #3 (old)
++++ Issue #3 (new)
+@@ -854,6 +854,10 @@
+ Latest updates
+ 
+ News announcement
++16 December 2025
++New measures to make EU health sector more innovative, competitive and resilient
++1 min read
++News announcement
+ 15 December 2025
+ MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
+ 1 min read
+@@ -864,10 +868,6 @@
+ News announcement
+ 27 November 2025
+ The EUDAMED four first modules will be mandatory to use as from 28 May 2026
+-1 min read
+-News announcement
+-10 November 2025
+-Coordinated assessment for clinical investigations: a call for expression of interest
+ 1 min read
+ See all
+ 
+```
+
+**Added links (all):**
+- https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
+
+**Removed links (all):**
+- https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
+
+### Issue #4
+**Page:** [https://health.ec.europa.eu/medical-devices-sector/new-regulations_en](https://health.ec.europa.eu/medical-devices-sector/new-regulations_en)
+**Changes:** Text & Links
+
+**Full text diff:**
+```
+--- Issue #4 (old)
++++ Issue #4 (new)
+@@ -146,6 +146,29 @@
+ 
+ 
+ 
++Simpler and more effective rules for medical devices – Commission proposal for a targeted revision of the medical devices regulations
++On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices to make them easier, faster and more effective and further promote competitiveness, innovation and a high-level of patient safety in this key sector. The proposal will simplify EU rules for medical devices, support the digitalisation of procedures, and offer a modern, adaptive framework so that companies can respond to changing market conditions and patient needs:
++Proposal for a regulation to reduce and simply rules on medical and in vitro diagnostic devices
++The adoption of the Legislative proposal was announced in a
++press release
++.
++The key elements of the revision are summarised in a
++factsheet
++, and in a
++questions and answers document
++.
++Two staff working documents support the proposal:
++SWD on targeted evaluation
++SWD on cost savings analysis
++The proposal has been submitted to the
++European Parliament
++and the
++Council
++. To become binding Union law, the co-legislators need to adopt the text by ordinary legislative procedure. An overview of this procedure is available in the
++European Parliament
++website. You can follow the development of the legislative decision-making process on the
++"Legislative Observatory" of the European Parliament
++.
+ Medical Devices regulations
+ The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years. The priority was to ensure a robust, transparent and sustainable regulatory framework and maintain a high level of safety, while supporting innovation.
+ Two new regulations on medical devices and in vitro diagnostic medical devices entered into force in May 2017.
+@@ -261,7 +284,7 @@
+ 2022
+ Report – Commission’s power to adopt delegated acts for in vitro diagnostic and other medical devices (COM(2022) 182 final)
+ Other acts
+-Decision 2025/2371 – functional specifications of electronic systems in Eudamed database
++Decision 2025/2371 – Notice declaring the functionality of the first four modules of EUDAMED
+ Corrigenda to the regulations
+ 2019
+ Corrigendum to Regulation 2017/745 – medical devices (December 2019)
+@@ -303,6 +326,10 @@
+ Latest updates
+ 
+ News announcement
++16 December 2025
++New measures to make EU health sector more innovative, competitive and resilient
++1 min read
++News announcement
+ 15 December 2025
+ MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
+ 1 min read
+@@ -313,10 +340,6 @@
+ News announcement
+ 27 November 2025
+ The EUDAMED four first modules will be mandatory to use as from 28 May 2026
+-1 min read
+-News announcement
+-10 November 2025
+-Coordinated assessment for clinical investigations: a call for expression of interest
+ 1 min read
+ See all
+ 
+@@ -387,7 +410,7 @@
+ Accessibility
+ 
+ 
+-{"utility":"piwik","siteID":"f573665d-3da7-4fad-8552-baccf7ee0b46","sitePath":["health.ec.europa.eu"],"instance":"ec","dimensions":[{"id":3,"value":"Page"},{"id":4,"value":"medical-device"},{"id":5,"value":"Directorate-General-for-Health-and-Food-Safety"},{"id":6,"value":"New Regulations"},{"id":7,"value":"fafbce50-281c-4195-a2d7-22c9fc22c58f"},{"id":8,"value":"EC - STANDARDISED"},{"id":9,"value":"medical-device organisation-of-health-care health-policy"},{"id":10,"value":"Default landing page"},{"id":12,"value":"416"}]}
++{"utility":"piwik","siteID":"f573665d-3da7-4fad-8552-baccf7ee0b46","sitePath":["health.ec.europa.eu"],"instance":"ec","dimensions":[{"id":3,"value":"Page"},{"id":4,"value":"medical-device"},{"id":5,"value":"Directorate-General-for-Health-and-Food-Safety"},{"id":6,"value":"New Regulations"},{"id":7,"value":"fafbce50-281c-4195-a2d7-22c9fc22c58f"},{"id":8,"value":"EC - STANDARDISED"},{"id":9,"value":"medical-device organisation-of-health-care health-policy"},{"id":10,"value":"Default landing page"},{"id":12,"value":"482"}]}
+ 
+ {"utility":"cck"}
+ 
+```
+
+**Added links (all):**
+- http://www.consilium.europa.eu/
+- http://www.europarl.europa.eu/
+- http://www.europarl.europa.eu/aboutparliament/en/0080a6d3d8/Ordinary-legislative-procedure.html
+- http://www.europarl.europa.eu/oeil/home/home.do
+- https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
+- https://ec.europa.eu/commission/presscorner/detail/en/qanda_25_3078
+- https://health.ec.europa.eu/publications/evaluation-medical-and-diagnostic-device-regulations-proposal-simplify-and-lessen-regulatory-burdens_en
+- https://health.ec.europa.eu/publications/factsheet-better-rules-medical-devices-better-outcomes-eu-patients_en
+- https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
+- https://health.ec.europa.eu/publications/staff-working-document-cost-savings-proposal-reduce-and-simplify-regulations-medical-and-diagnostic_en
+
+**Removed links (all):**
+- https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
+
+### Issue #5
+**Page:** [https://health.ec.europa.eu/medical-devices-sector/directives_en](https://health.ec.europa.eu/medical-devices-sector/directives_en)
+**Changes:** Text & Links
+
+**Full text diff:**
+```
+--- Issue #5 (old)
++++ Issue #5 (new)
+@@ -260,6 +260,10 @@
+ Latest updates
+ 
+ News announcement
++16 December 2025
++New measures to make EU health sector more innovative, competitive and resilient
++1 min read
++News announcement
+ 15 December 2025
+ MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
+ 1 min read
+@@ -270,10 +274,6 @@
+ News announcement
+ 27 November 2025
+ The EUDAMED four first modules will be mandatory to use as from 28 May 2026
+-1 min read
+-News announcement
+-10 November 2025
+-Coordinated assessment for clinical investigations: a call for expression of interest
+ 1 min read
+ See all
+ 
+```
+
+**Added links (all):**
+- https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
+
+**Removed links (all):**
+- https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
+
+### Issue #6
+**Page:** [https://health.ec.europa.eu/medical-devices-sector/vitro-diagnostics_en](https://health.ec.europa.eu/medical-devices-sector/vitro-diagnostics_en)
+**Changes:** Text & Links
+
+**Full text diff:**
+```
+--- Issue #6 (old)
++++ Issue #6 (new)
+@@ -165,6 +165,10 @@
+ Latest updates
+ 
+ News announcement
++16 December 2025
++New measures to make EU health sector more innovative, competitive and resilient
++1 min read
++News announcement
+ 15 December 2025
+ MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
+ 1 min read
+@@ -175,10 +179,6 @@
+ News announcement
+ 27 November 2025
+ The EUDAMED four first modules will be mandatory to use as from 28 May 2026
+-1 min read
+-News announcement
+-10 November 2025
+-Coordinated assessment for clinical investigations: a call for expression of interest
+ 1 min read
+ See all
+ 
+```
+
+**Added links (all):**
+- https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
+
+**Removed links (all):**
+- https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
+
+### Issue #7
+**Page:** [https://health.ec.europa.eu/medical-devices-sector/eudamed_en](https://health.ec.europa.eu/medical-devices-sector/eudamed_en)
+**Changes:** Text & Links
+
+**Full text diff:**
+```
+--- Issue #7 (old)
++++ Issue #7 (new)
+@@ -170,6 +170,10 @@
+ Latest updates
+ 
+ News announcement
++16 December 2025
++New measures to make EU health sector more innovative, competitive and resilient
++1 min read
++News announcement
+ 15 December 2025
+ MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
+ 1 min read
+@@ -180,10 +184,6 @@
+ News announcement
+ 27 November 2025
+ The EUDAMED four first modules will be mandatory to use as from 28 May 2026
+-1 min read
+-News announcement
+-10 November 2025
+-Coordinated assessment for clinical investigations: a call for expression of interest
+ 1 min read
+ See all
+ 
+```
+
+**Added links (all):**
+- https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
+
+**Removed links (all):**
+- https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
+
+### Issue #8
+**Page:** [https://health.ec.europa.eu/medical-devices-sector/guidance-and-useful-information_en](https://health.ec.europa.eu/medical-devices-sector/guidance-and-useful-information_en)
+**Changes:** Text & Links
+
+**Full text diff:**
+```
+--- Issue #8 (old)
++++ Issue #8 (new)
+@@ -167,6 +167,10 @@
+ Latest updates
+ 
+ News announcement
++16 December 2025
++New measures to make EU health sector more innovative, competitive and resilient
++1 min read
++News announcement
+ 15 December 2025
+ MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
+ 1 min read
+@@ -177,10 +181,6 @@
+ News announcement
+ 27 November 2025
+ The EUDAMED four first modules will be mandatory to use as from 28 May 2026
+-1 min read
+-News announcement
+-10 November 2025
+-Coordinated assessment for clinical investigations: a call for expression of interest
+ 1 min read
+ See all
+ 
+```
+
+**Added links (all):**
+- https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
+
+**Removed links (all):**
+- https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
+
+### Issue #9
+**Page:** [https://health.ec.europa.eu/medical-devices-sector/coordination-and-governance_en](https://health.ec.europa.eu/medical-devices-sector/coordination-and-governance_en)
+**Changes:** Text & Links
+
+**Full text diff:**
+```
+--- Issue #9 (old)
++++ Issue #9 (new)
+@@ -171,6 +171,10 @@
+ Latest updates
+ 
+ News announcement
++16 December 2025
++New measures to make EU health sector more innovative, competitive and resilient
++1 min read
++News announcement
+ 15 December 2025
+ MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
+ 1 min read
+@@ -181,10 +185,6 @@
+ News announcement
+ 27 November 2025
+ The EUDAMED four first modules will be mandatory to use as from 28 May 2026
+-1 min read
+-News announcement
+-10 November 2025
+-Coordinated assessment for clinical investigations: a call for expression of interest
+ 1 min read
+ See all
+ 
+```
+
+**Added links (all):**
+- https://ec.europa.eu/commission/presscorner/detail/en/ip_25_3077
+
+**Removed links (all):**
+- https://health.ec.europa.eu/medical-devices-clinical-investigations-and-performance-studies/pilot-coordinated-assessment-cips_en
+
+### Issue #11
+**Page:** [https://www.iso.org/insights/standards-world](https://www.iso.org/insights/standards-world)
+**Changes:** Text
+
+**Full text diff:**
+```
+--- Issue #11 (old)
++++ Issue #11 (new)
+@@ -535,16 +535,16 @@
+ 
+ 
+ 
+-New project
+-
+-ISO/UNDP AWI 53002
++Committee Draft
++
++ISO/UNDP CD 53002
+ 
+ 
+ 
+ Management systems for the United Nations Sustainable Development Goals SDGs - Implementation guidance
+ 
+ Reference number
+-ISO/UNDP AWI 53002
++ISO/UNDP CD 53002
+ 
+ 
+ 
+@@ -554,15 +554,15 @@
+ 
+ 
+ 
+-New project
+-
+-
+-
+-
+-
+-
+-
+-ISO/UNDP AWI 53002
++Committee Draft
++
++
++
++
++
++
++
++ISO/UNDP CD 53002
+ 
+ 
+ Management systems for the United Nations Sustainable Development Goals SDGs - Implementation guidance
+```