Category European Commission

Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs published

Last updated: 7 December 2023 See updates at the end of the post. On 20 March 2023, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published. This…

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EMA feedback to EC on the impact of the removal of TiO2 from the list of authorised food additives in medicinal products

Last updated: 28 November 2023 See updates at the end of the post. In September 2021, the European Medicines Agency (EMA) provided final feedback to the European Commission (EC) on its request to evaluate the impact of the removal of…

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New Unitary Patent system launched, pioneering a new era of patent protection and enforcement in the EU

The Commission today welcomed the launch of the Unitary Patent system. About the Unitary Patent system The Unitary Patent system: What are the main advantages of the Unitary Patent System The main advantages of the new Unitary Patent system are:…

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Commission adopts proposal allowing more time to certify medical devices to mitigate risks of shortages

On 6 January 2023,  the European Commission adopted a proposal allowing more time to certify medical devices to mitigate the risk of shortages. The proposal: Further details are provided below. What does the length of the proposed extension period depend…

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