The Model Commercial Lease (MCL) Committee has published the first two agreements for lease (AFLs) as part of the MCL document suite. The MCL AFLs are based on the same principles as the MCL Lease and are intended to provide a fair and balanced starting point for landlord and tenant relationships prior to the grant of a lease. Two versions have been published: (1) MCL-AFL-01, intended for straightforward agreements where landlords undertake minor repurposing works alongside tenant works and (2) MCL-AFL-02, for arrangements involving tenant works only, with no landlord works. The Committee is inviting feedback on the style and content of the MCL AFLs before developing longer form documents or introducing additional supplementary provisions and obligations for more substantial landlord works.

The Model Commercial Lease (MCL) Working Group has published amended versions of the MCL suite of documents. The guidance section contains a new page, ‘MCL changes – February 2024’ which provides full details of any changes made and the reasons for making them (where relevant). Older versions of MCL documents can be downloaded by clicking on the document number on the relevant page.

The Model Commercial Lease (MCL) Working Group has published version 1.8 of the MCL suite of documents, incorporating changes from the latest edition of the Better Buildings Partnership Green Lease Toolkit. The Guidance section of the MCL website now includes a new page titled ‘MCL Update – April 2025’, which provides links to an explanatory note outlining the changes and their rationale, a note on the inclusion of Green Lease Toolkit provisions, and a red-line version of the office lease for part of a building.

Model Commercial Lease (MCL) has updated its leases of part of a building on an estate. The landlord’s obligation to enter into wayleaves has been updated to refer to both paragraphs 1.2 and 1.3 of Part 1 of Schedule 1. The change affects MCL-OFFICE-04, MCL-RETAIL-05, MCL-RETAIL-06, MCL-FOODDRINK-04 and MCL-FOODDRINK-07, with an ‘a’ added to the relevant leases’ version numbers.

Medical Decontamination Centre

The Medicines Discovery Catapult (MDC), UK BioIndustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI) have released a report titled 'State of the Discovery Nation' which shows the effects of the current economic instability on companies in the life sciences sector. The report noted that investment in life science companies is beneficial to patient health, UK productivity and investor returns and stressed that SMEs are an essential source of innovation, making up 70–80% of the life sciences sector’s 6,850 businesses. UK life science companies generated £108.1bn in turnover and accounted for 35% of all life science start-ups in 2021. The report also highlighted that the most promising innovations and companies will be at risk if there is not a shift in mindset and practical steps to boost investment. This could delay the delivery of new medicines to patients who need them the most.

The Medical Device Coordination Group (MDCG) has issued a comprehensive guidance document, endorsed in June 2025, addressing performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. The document, developed by representatives from all Member States and chaired by a representative of the European Commission, delineates the applicable regulatory framework and procedures. It clarifies the definitions and distinctions between analytical and clinical performance studies, stipulates when a device is deemed an in vitro diagnostic medical device (IVD) and consequently subject to the Regulation, and sets out responsibilities regarding the assignment of intended purpose and conduct of performance studies. The guidance details the requirements for application or notification to competent authorities, including specific scenarios such as studies involving surgically invasive sample-taking, companion diagnostics, and left-over samples, alongside the relevant articles of the Regulation. It further provides practical instructions on documentation, submission requirements, safety reporting, and the handling of substantial modifications. The document serves as a harmonised reference for sponsors of performance studies, clinical investigators, and manufacturers, ensuring compliance with the IVDR, while underscoring the importance of adhering to both European and national legislative requirements in the conduct of performance studies.

The Medical Device Coordination Group (MDCG) has published guidance on the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices and has, as a consequence, revised its guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)). EtO can be used for sterilisation during the manufacturing of medical devices and in vitro diagnostics, a process that falls within the regulatory obligations imposed by the MDR and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)). As such, EtO falls within the scope of the MDR and IVDR, despite not meeting the definition of a medical device or an accessory for a medical device when used during the manufacturing process. The revised guidance also emphasises that sterilisation agents such as EtO fall under the MDR unless they are considered multi-purpose products not specifically intended for medical device sterilisation; in such cases, they are covered by Regulation (EU) 528/2012 (the EU Biocidal Products Regulation).

The Medical Device Coordination Group (MDCG) has published guidance clarifying the regulatory responsibilities of app platform providers facilitating the availability of medical device software (MDSW) apps on the EU market. Chaired by a European Commission representative and composed of Member State delegates, the MDCG set out obligations under Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), and Regulation (EU) 2022/2065 (EU Digital Services Act, EU DSA). The guidance distinguishes between platform providers acting as intermediary service providers and those qualifying as distributors or importers.

The Medical Device Coordination Group (MDCG) has released three Device Specific Vigilance Guidance (DSVG) documents regarding the vigilance system for CE-marked devices. The DSVG 00, 01 and 02 aim to harmonise vigilance reporting and provide guidance for manufacturers of specific devices, devices for cardiac ablation and coronary stents and associated delivery systems. The guidance documents should be read alongside the requirements of Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)) and Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)). The three DSVGs do not replace or extend any of the requirements and highlight the way incidents and serious incidents should be reported, defined in Articles 2(64) and (65) of MDR and Article 2(67) and (68) of IVDR, in accordance with Articles 87 and 88 of MDR and Articles 82 and 83 of IVDR.

The Medical Device Coordination Group (MDCG) has published a Device Specific Vigilance Guidance (DSVG) to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices. The DSVG outlines the way to report incidents and serious incidents, defined in Article 2(64) of Regulation (EU) 2017/745 (the Medical Devices Regulations (MDR)) and in Article 2(67)-(68) of Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulations (IVDR)), with Specific Devices to the relevant Competent Authority. The guide notes that it is the manufacturer’s responsibility to judge each event on its own merit and to ensure compliance with the statutory reporting requirements contained within the MDR and IVDR. It covers individual serious incidents, periodic summary reporting and trend reporting.

The Medical Device Coordination Group (MDCG) has published guidance document MDCG 2025-8 on implementing Master Unique Device Identification-Device Identifier (UDI-DI) requirements for spectacle frames, lenses and ready-to-wear reading spectacles under EU Medical Device Regulation 2017/745. The guidance follows Commission Delegated Regulation 2025/1920 and provides manufacturers with technical implementation details including assignment rules, labelling requirements and Eudamed registration procedures, with mandatory compliance from 1 November 2028.