Category Medical Devices

Combination products- Implementation of the transitional provisions for medical devices in Switzerland

Combination products are medicinal products with a medical device component. Combination products can either be non-separable combinations or separable combinations. EU MDR amendment of 20 March 2023 Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional…

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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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Medical Device Coordination Group (MDCG) updates -October to December 2022

Guidance No About the guidance MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, Revision 1 – December…

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UK government responds to medical devices consultation with new plans to strengthen the regulation of medical devices

The UK government has responded to the medical devices consultation (the original consultation is half way down the page) held between September and November 2021, with new plans to strengthen the regulation of medical devices in the UK. Following the…

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Published EU commission implementing decisions on harmonised standards for medical devices drafted in support of the MDR and the IVDR

The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council have been published thus far: Commission Implementing Decision (EU)…

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