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European Parliament 🇪🇺

Description

The European Parliament is one of the legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union, it adopts European legislation, following a proposal by the European Commission.

Official website

https://www.europarl.europa.eu/portal/en

COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Implementing Regulation (EU) 2022/1107 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council

From European Parliament 🇪🇺

A draft implementing regulation amending specifications for class D in vitro diagnostic medical devices under EU Regulation 2017/746.

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Updated on August 19, 2024

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Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices

From European Parliament 🇪🇺

An EU implementing decision renewing the designation of entities for Unique Device Identifiers (UDIs) in medical devices field, effective from July 30, 2024.

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Updated on July 30, 2024

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Proposal for a COUNCIL DECISION on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law

From European Parliament 🇪🇺

A proposal for the European Union to sign the Council of Europe Framework Convention on Artificial Intelligence, focusing on human rights, democracy, and the rule of law.

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Updated on June 26, 2024

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COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices

From European Parliament 🇪🇺

A draft implementing regulation detailing procedural rules for cooperation among Member State Coordination Group, Commission, and European Medicines Agency on joint clinical assessments and scientific consultations for medicinal products and medical devices.

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Updated on June 26, 2024

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Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices)

From European Parliament 🇪🇺

A proposal for a decision within the European Union regarding an amendment to technical regulations and protocols in the EEA Agreement for enhanced crisis management in medicinal products and medical devices.

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Updated on June 11, 2024

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Commission Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices

From European Parliament 🇪🇺

The document is an EU Implementing Decision from 2024 amending standards for sterilization of healthcare products and packaging for medical devices.

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Updated on March 6, 2024

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Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products

From European Parliament 🇪🇺

The document is a Commission Implementing Decision amending standards for medical gloves, biological evaluation of devices, sterilization, packaging, and processing of healthcare products.

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Updated on March 6, 2024

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Commission Decision of 24 January 2024 establishing the European Artificial Intelligence Office

From European Parliament 🇪🇺

Commission Decision establishing the European Artificial Intelligence Office.

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Updated on January 24, 2024

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Proposal for a COUNCIL REGULATION amending Regulation (EU) 2021/1173 as regards an EuroHPC initiative for start-ups to boost European leadership in trustworthy Artificial Intelligence

From European Parliament 🇪🇺

A proposal to amend a regulation for an EuroHPC initiative aimed at boosting European leadership in trustworthy AI through start-ups.

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Updated on January 24, 2024

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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices

From European Parliament 🇪🇺

This document is a proposal to amend regulations regarding the roll-out of Eudamed, supply interruptions, and transitional provisions for medical devices.

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Updated on January 23, 2024

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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

From European Parliament 🇪🇺

A proposal to amend regulations on chemicals in the European Union, focusing on re-attribution of tasks and improving agency cooperation.

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Updated on December 7, 2023

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Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices

From European Parliament 🇪🇺

Commission Implementing Regulation (EU) 2023/2713 designates EU reference laboratories for in vitro diagnostic medical devices.

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Updated on December 5, 2023

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Commission Implementing Decision (EU) 2023/2634 of 27 November 2023 concerning the extension of the action taken by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products permitting the making available on the market and use of the biocidal product Biobor JF in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2023) 7951)

From European Parliament 🇪🇺

Commission extends permission for the use of biocidal product Biobor JF in accordance with EU regulations.

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Updated on November 27, 2023

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Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices

From European Parliament 🇪🇺

Commission Regulation (EU) 2023/2482 amends the regulation on bis(2-ethylhexyl) phthalate (DEHP) in medical devices.

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Updated on November 13, 2023

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Corrigendum to Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Official Journal of the European Union L 185 of 24 July 2023)

From European Parliament 🇪🇺

Corrigendum to Commission Delegated Directive (EU) 2023/1526 amending Directive 2011/65/EU regarding lead exemption in medical devices.

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Updated on July 27, 2023

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COMMISSION DELEGATED REGULATION (EU) /... amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses

From European Parliament 🇪🇺

This document is a delegated regulation that amends the EU regulation on Unique Device Identifiers for contact lenses.

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Updated on July 10, 2023

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Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses

From European Parliament 🇪🇺

Commission Delegated Regulation (EU) 2023/2197 amends EU Regulation 2017/745 on Unique Device Identifiers for contact lenses.

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Updated on July 10, 2023

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Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices

From European Parliament 🇪🇺

Commission Implementing Decision (EU) 2023/1410 amends harmonised standards for sterilization of healthcare products and biological evaluation of medical devices.

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Updated on July 4, 2023

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Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council (Text with EEA relevance)

From European Parliament 🇪🇺

Commission Implementing Regulation (EU) 2023/1194 amends the transitional provisions for certain non-medical products listed in Annex XVI to Regulation (EU) 2017/745.

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Updated on June 20, 2023

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Commission Delegated Directive (EU) 2023/1526 of 16 May 2023 amending Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Text with EEA relevance)

From European Parliament 🇪🇺

Commission Delegated Directive (EU) 2023/1526 amends Directive 2011/65/EU, exempting lead as a thermal stabilizer in PVC used in medical devices.

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Updated on May 16, 2023

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