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UK regulation of medical devices from 1 January 2021

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more

MDCG guidance for consultations of authorities on devices incorporating a medicinal product

On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more

The Belgian Data Protection Authority Publishes Recommendation Concerning Data Processing for Direct Marketing Purposes

On January 17, The Belgian Data Protection Authority (DPA) published Recommendation no 01/2020 providing Guidance on direct marketing. The Recommendation provides a methodology on how to comply with the General Data...more

Brexit, medical devices and transfer of notified bodies

In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a "common rulebook" between the parties in relation to goods....more

MDR and IVDR: MedTech Europe calls for an extension of the transitional provisions

On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and...more

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