|
1 | | -### Issue #5 |
2 | | -**Page:** [https://health.ec.europa.eu/medical-devices-sector/directives_en](https://health.ec.europa.eu/medical-devices-sector/directives_en) |
3 | | -**Changes:** Text |
| 1 | +### Issue #4 |
| 2 | +**Page:** [https://health.ec.europa.eu/medical-devices-sector/new-regulations_en](https://health.ec.europa.eu/medical-devices-sector/new-regulations_en) |
| 3 | +**Changes:** Text & Links |
4 | 4 |
|
5 | 5 | **Full text diff:** |
6 | 6 | ``` |
7 | | ---- Issue #5 (old) |
8 | | -+++ Issue #5 (new) |
9 | | -@@ -267,11 +267,11 @@ |
10 | | - 1 min read |
11 | | - News announcement |
12 | | - 16 December 2025 |
13 | | --Factsheet - Better rules for medical devices, better outcomes for EU patients |
14 | | -+New measures to make EU health sector more innovative, competitive and resilient |
15 | | - 1 min read |
16 | | - News announcement |
17 | | - 16 December 2025 |
18 | | --New measures to make EU health sector more innovative, competitive and resilient |
19 | | -+Factsheet - Better rules for medical devices, better outcomes for EU patients |
20 | | - 1 min read |
21 | | - See all |
| 7 | +--- Issue #4 (old) |
| 8 | ++++ Issue #4 (new) |
| 9 | +@@ -290,7 +290,9 @@ |
| 10 | + 2025 |
| 11 | + Delegated Regulation 2025/1920 – UDI assignment for spectacle frames and lenses |
| 12 | + 2023 |
| 13 | +-Delegated Regulation 2023/2197 – UDI assignment for contact lenses and application-date amendment |
| 14 | ++Delegated Regulation 2023/2197 – UDI assignment for contact lenses |
| 15 | ++and |
| 16 | ++Commission Delegated Regulation (EU) 2025/788 amending the date of application |
| 17 | + Delegated Regulation 2023/502 – frequency of complete re-assessments of notified bodies (C/2022/8640) |
| 18 | + Delegated Regulation 2023/503 – frequency of complete re-assessments of notified bodies (C/2022/8649) |
| 19 | + 2022 |
| 20 | +@@ -422,7 +424,7 @@ |
| 21 | + Accessibility |
22 | 22 |
|
23 | | -``` |
24 | | - |
25 | | - |
26 | | -### Issue #6 |
27 | | -**Page:** [https://health.ec.europa.eu/medical-devices-sector/vitro-diagnostics_en](https://health.ec.europa.eu/medical-devices-sector/vitro-diagnostics_en) |
28 | | -**Changes:** Text |
29 | | - |
30 | | -**Full text diff:** |
31 | | -``` |
32 | | ---- Issue #6 (old) |
33 | | -+++ Issue #6 (new) |
34 | | -@@ -172,11 +172,11 @@ |
35 | | - 1 min read |
36 | | - News announcement |
37 | | - 16 December 2025 |
38 | | -+New measures to make EU health sector more innovative, competitive and resilient |
39 | | -+1 min read |
40 | | -+News announcement |
41 | | -+16 December 2025 |
42 | | - Factsheet - Better rules for medical devices, better outcomes for EU patients |
43 | | --1 min read |
44 | | --News announcement |
45 | | --16 December 2025 |
46 | | --New measures to make EU health sector more innovative, competitive and resilient |
47 | | - 1 min read |
48 | | - See all |
49 | 23 |
|
50 | | -``` |
51 | | - |
52 | | - |
53 | | -### Issue #7 |
54 | | -**Page:** [https://health.ec.europa.eu/medical-devices-sector/eudamed_en](https://health.ec.europa.eu/medical-devices-sector/eudamed_en) |
55 | | -**Changes:** Text |
56 | | - |
57 | | -**Full text diff:** |
58 | | -``` |
59 | | ---- Issue #7 (old) |
60 | | -+++ Issue #7 (new) |
61 | | -@@ -177,11 +177,11 @@ |
62 | | - 1 min read |
63 | | - News announcement |
64 | | - 16 December 2025 |
65 | | -+New measures to make EU health sector more innovative, competitive and resilient |
66 | | -+1 min read |
67 | | -+News announcement |
68 | | -+16 December 2025 |
69 | | - Factsheet - Better rules for medical devices, better outcomes for EU patients |
70 | | --1 min read |
71 | | --News announcement |
72 | | --16 December 2025 |
73 | | --New measures to make EU health sector more innovative, competitive and resilient |
74 | | - 1 min read |
75 | | - See all |
| 24 | +-{"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 health-policy"},{"id":10,"value":"Default landing page"},{"id":12,"value":"503"}]} |
| 25 | ++{"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 health-policy"},{"id":10,"value":"Default landing page"},{"id":12,"value":"505"}]} |
76 | 26 |
|
77 | | -``` |
78 | | - |
79 | | - |
80 | | -### Issue #8 |
81 | | -**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) |
82 | | -**Changes:** Text |
83 | | - |
84 | | -**Full text diff:** |
85 | | -``` |
86 | | ---- Issue #8 (old) |
87 | | -+++ Issue #8 (new) |
88 | | -@@ -174,11 +174,11 @@ |
89 | | - 1 min read |
90 | | - News announcement |
91 | | - 16 December 2025 |
92 | | -+New measures to make EU health sector more innovative, competitive and resilient |
93 | | -+1 min read |
94 | | -+News announcement |
95 | | -+16 December 2025 |
96 | | - Factsheet - Better rules for medical devices, better outcomes for EU patients |
97 | | --1 min read |
98 | | --News announcement |
99 | | --16 December 2025 |
100 | | --New measures to make EU health sector more innovative, competitive and resilient |
101 | | - 1 min read |
102 | | - See all |
| 27 | + {"utility":"cck"} |
103 | 28 |
|
104 | 29 | ``` |
105 | 30 |
|
106 | | - |
107 | | -### Issue #9 |
108 | | -**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) |
109 | | -**Changes:** Text |
110 | | - |
111 | | -**Full text diff:** |
112 | | -``` |
113 | | ---- Issue #9 (old) |
114 | | -+++ Issue #9 (new) |
115 | | -@@ -178,11 +178,11 @@ |
116 | | - 1 min read |
117 | | - News announcement |
118 | | - 16 December 2025 |
119 | | -+New measures to make EU health sector more innovative, competitive and resilient |
120 | | -+1 min read |
121 | | -+News announcement |
122 | | -+16 December 2025 |
123 | | - Factsheet - Better rules for medical devices, better outcomes for EU patients |
124 | | --1 min read |
125 | | --News announcement |
126 | | --16 December 2025 |
127 | | --New measures to make EU health sector more innovative, competitive and resilient |
128 | | - 1 min read |
129 | | - See all |
130 | | - |
131 | | -``` |
| 31 | +**Added links (all):** |
| 32 | +- https://eur-lex.europa.eu/eli/reg_del/2025/788/oj |
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