COM(2025) 1023
Proposal for a Regulation of the European Parliament and of the Council .../... amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I
Þýðing EES-gerðar birtist hér á íslensku við upptöku í EES-samninginn og birtingu í EES-viðbæti.
Gerð ekki til á íslensku
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Tillaga sem gæti verið EES-tæk
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Gerð í skoðun hjá EES-EFTA ríkjunum
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Drög að ákvörðun sameiginlegu nefndarinnar í skoðun
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Ákvörðun sameiginlegu nefndarinnar samþykkt en hefur ekki öðlast gildi
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Tekin upp í EES-samninginn og í gildi
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Tekin upp í EES-samninginn en ekki lengur í gildi
Staða og svið tillögu/gerðar
| Staða tillögu/gerðar | Tillaga ESB sem er merkt EES-tæk |
|---|---|
| Svið (EES-samningur, viðauki) | 02 Tæknilegar reglugerðir, staðlar, prófanir og vottun, 02.13 Lyf |
Staða innan stjórnsýslunnar
| Stofnun hefur lokið yfirferð | Á ekki við |
|---|---|
| Þörf á aðlögun í ákvörðun sameiginlegu nefndarinnar | Ekki þörf á aðlögun |
| Fagráðuneyti hefur lokið vinnu við upplýsingablað og samþykkir drög að ákvörðun sameiginlegu nefndarinnar | Nei |
| Alþingi hefur lokið mati sínu | Nei |
| Utanríkisráðuneyti hefur veitt samþykki fyrir því að drög að ákvörðun sameiginlegu nefndarinnar séu send til ESB | Nei |
Innleiðing
| Innleiðing | Engar laga- eða reglugerðabreytingar |
|---|---|
| Staða innleiðingarvinnu | Innleiðing ekki hafin |
Samráð
| Samráð | Nei |
|---|
Áhrif
| Áætlaður kostnaður hins opinbera | Ekki vitað |
|---|
Ábyrgðaraðilar
| Ábyrgt ráðuneyti | Heilbrigðisráðuneytið |
|---|
Vinnslustig (pipeline stage)
| COM numer | COM(2025) 1023 |
|---|---|
| Dagsetning tillögu ESB | |
| Dagsetning tillögu |
Leggur til breytingar á (Proposes to amend)
| 32024R1689 | Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) | Gerð í skoðun hjá EES EFTA-ríkjunum |
| 32022R0123 | Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices | Tekin upp í EES-samninginn og í gildi |
| 32017R0746 | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU | Tekin upp í EES-samninginn og í gildi |
| 32017R0745 | Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC | Tekin upp í EES-samninginn og í gildi |
Breytt af (Modified by)
| SEC(2025) 1052 52025SC1052 |
work related to work | ||
| SEC(2025) 1051 52025SC1051 |
work related to work | ||
| SEC(2025) 1050 52025SC1050 |
work related to work | ||
| COM(2025) 1022 52025PC1022 |
work related to work | Proposal for a Regulation of the European Parliament and of the Council .../... on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) | Tillaga sem gæti verið EES-tæk |
Breytir (Modifies)
| COM(2025) 1031 52025PC1031 |
work related to work | Proposal for a Directive of the European Parliament and of the Council .../... amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs | Tillaga sem gæti verið EES-tæk |
| COM(2025) 1024 52025DC1024 |
work related to work | ||
| 32024R1689 | proposes to amend | Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) | Gerð í skoðun hjá EES EFTA-ríkjunum |
| 32022R0123 | proposes to amend | Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices | Tekin upp í EES-samninginn og í gildi |
| 32017R0746 | proposes to amend | Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU | Tekin upp í EES-samninginn og í gildi |