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NEWS
The European Association of Medical devices Notified Bodies (Team-NB) has aligned on a strategy to address challenges encountered with the implementation of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)). Team-NB emphasised the role of Notified Bodies in ensuring safety and performance of devices and highlighted that delays in technical documentation submissions by manufacturers lengthen the overall certification timelines and cause potential bottlenecks toward the end of the transitional timelines in 2027 and 2028, stating that modification of regulations and associated guidance could prevent such delays. Team-NB also emphasised the need to simplify and consolidate divergent approaches associated with a given legislative process or requirement, supported streamlined pathways for breakthrough and life-saving products and increased SME financial support, and were in favour of consistent and binding clarification of requirements.
NEWS
The European Association of Medical Devices Notified Bodies (Team-NB) has submitted feedback on the proposed targeted revision of the EU medical devices and in vitro diagnostics rules. Team-NB supports the objective of ensuring that only safe and effective devices are placed on the EU market but raises concerns that the proposals may reduce preventive regulatory safeguards and increase risks to patient safety. It highlights potential impacts of reduced notified body involvement, including changes to surveillance, recertification and transparency requirements, and calls for a proportionate, performance-based oversight model. Team-NB also emphasises the need for clearer definitions and improved access to regulatory systems, including European Database on Medical Devices to support effective implementation
PRECEDENTS
This Agreement is made on [date] Parties 1 [Insert name of party] [of OR a company incorporated in England and Wales under number [insert registered number] whose registered office is at] [insert address] (Party 1); and 2 [Insert name of party] [of OR a company incorporated in England and Wales under number [insert registered number] whose registered office is at] [insert address] (Party 2), each of Party 1 and Party 2 being a party and together the parties. BACKGROUND (A) Party 1 provides [insert description of goods and/or services]. (B) Party 2 provides [insert description of goods and/or services]. (C) The parties wish to submit a Bid as a joint tender to the Customer in response to the Invitation to Tender. (D) The parties wish to set out their obligations and regulate their rights in relation to the Bid and, if their Bid is successful, they intend to enter the Customer Contract[ and the Joint Venture Agreement] in accordance with this Agreement. The parties agree: 1 Definitions and interpretation 1.1 In this Agreement: Affiliate • means any entity that directly or indirectly Controls, is Controlled by, or is under common Control with, another entity; Bid • means the offer to be
NEWS
The Home Office has confirmed that Tech Nation will continue to be the endorsing body for the Global Talent Digital Technology visa route for the next three years. This follows a recent tender process. The news has been announced in an update to the Tech Nation website.
NEWS
MLex: Tech companies—from US giants such as Meta Platforms, Google and Microsoft to European startups, worry that EU lawmakers are rushing to wrap up a draft EU law to streamline procedures for privacy probes. Major questions on setting deadlines, accessing files and the scope of investigations haven’t been resolved, MLex understands. Civil society groups share the concern about a rushed process.
NEWS
The Society of Authors (SoA) has written to major tech companies, including Microsoft, Meta and Google, demanding that they obtain licences and authorisation from rights holders before using their copyright-protected works for training or operating generative AI systems. The SoA asserts that the use of the works without consent constitutes copyright infringement under UK and international law and rejects the defence that works which are available in a digital format and are accessible online can be used without permission. This move follows a resolution passed by SoA members and similar actions by the Creative Rights Alliance, aiming to protect creators’ rights and ensure fair compensation.
NEWS
MLex: A technology lobby group has urged the European Data Protection Board (EDPB) to conduct a public consultation with stakeholders before it issues an opinion this month on Meta's 'pay or consent' subscription model, MLex has learned.
NEWS
The Department for Science, Innovation and Technology, Secretary, Peter Kyle has welcomed significant investments from four major US tech firms—CyrusOne, ServiceNow, CloudHQ, and CoreWeave, which will enhance the UK's data centre infrastructure, boosting the nation's computing power and facilitating the development of advanced AI technologies. The new data centres will have more computing power and data storage and use complex machine learning models and algorithms, which will boost the roll out of AI in areas such as healthcare.
NEWS
TechUK has published its analysis of the UK government's Immigration White Paper, released on 12 May 2025. The White Paper outlines substantial reforms to the UK's immigration system. Key changes include raising the skilled visa threshold to RQF6 (graduate level), replacing the Immigration Salary List with a new Temporary Shortage List, and introducing mandatory workforce strategies for sectors with high levels of overseas recruitment. TechUK expresses concern over the increase to the Immigration Skills Charge (ISC), arguing that it penalises employers for addressing skills shortages through international recruitment. The analysis also criticises the decision to reduce the Graduate visa from two years to 18 months, stating that it undermines the government's goal of attracting and retaining highly-skilled graduates from UK universities. In response, TechUK proposes several recommendations to improve the immigration policy and promote economic growth.
NEWS
Technical Advice Note 19 (TAN 19) – Telecommunications has been revoked in Wales. Planning policy guidance and advice on telecommunications can be found in Future Wales: the national plan 2040, Planning Policy Wales (PPW) and the Code of Best Practice on Mobile Phone Network Development for Wales. The PPW has been amended accordingly.
GLOSSARY
A consultant appointed by the Authority or another key party to provide technical advice to that party on the project and report to them on the progress of the project.
PRACTICE NOTES
This Practice Note provides practical guidance on the technical barriers to trade (TBT) and sanitary and phytosanitary (SPS) measures under the UK and Southern African Customs Union (SACU) and Mozambique Economic Partnership Agreement (UK-SACUM EPA). Introduction The UK-SACUM EPA a free trade agreement between the UK and SACU and Mozambique. It was negotiated as a result of Brexit and as such is mostly a copy of the Economic Partnership Agreement that the UK enjoyed when it was still part of the EU. The UK-SACUM EPA came into force on 1 January 2021. It covers predominately trade in goods. For guidance hereon, see Practice Note: Trade in goods under the UK-SACUM EPA. This practice note covers TBT and SPS measures as they apply under the UK-SACUM EPA. TBT under the UK-SACUM EPA For guidance on TBT measures under the World Trade Organization’s (WTO) Agreement on Technical Barriers to Trade (TBT Agreement), see Practice Note: An introduction to the Agreement on Technical Barriers to Trade. Multilateral obligations The