The Medical Device Coordination Group (MDCG) has issued a significant update to its guidance on the European Medical Device Nomenclature (EMDN). This revision, published in January 2025, expands the original 2021 document with answers to nearly 20 additional questions. The updated guidance provides crucial information on assigning EMDN codes to Unique Device Identifiers (UDI-DIs), clarifies the annual review procedure, and addresses the current inability to notify users of annual code changes. Alongside this, the MDCG has released details of its nomenclature working group's 2024 decisions, offering insights into the acceptance, partial acceptance, or rejection of code change requests. These updates aim to enhance understanding and implementation of the EMDN across the medical device industry and regulatory landscape.

The Medical Device Coordination Group (MDCG) has published a revised FAQ document on the European Medical Device Nomenclature (EMDN), updating earlier guidance and providing additional clarification on its use under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The EMDN supports the functioning of the European database on medical devices (EUDAMED) and is used by manufacturers to register devices and assign Unique Device Identifiers. The updated guidance includes clarifications on the use of code extensions, distinguishing between ‘99’ for terminal classifications and ‘90’ for non-terminal groupings and provides further direction on assigning codes, including for devices with multiple intended uses and for products without a medical purpose listed in Annex XVI.

The Medical Device Coordination Group (MDCG) has released two revised documents providing updated guidance for the medical device industry.

The Medical Device Coordination Group (MDCG) has revised its guidance document MDCG 2023-3 on vigilance terms and concepts under Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)). The updated document makes changes to incident reporting criteria and practical examples for medical devices, including in vitro diagnostic (IVD) medical devices, clarifies the roles and responsibilities of economic operators, such as manufacturers, authorised representatives, importers, and distributors, in the vigilance process, and provides guidance on the timelines and procedures for reporting incidents, including the use of the European Database on Medical Devices (EUDAMED). Additionally, the guidance includes recommendations on the content and structure of periodic summary reports and trend reports, as well as guidance on field safety corrective actions, including the notification process and the involvement of competent authorities. It also provides clarifications on the vigilance requirements for legacy devices, devices without an intended medical purpose, and custom-made devices.

Multi Element Bottles: Used to store light water reactor spent fuel assemblies in THORP Storage Ponds.

Mobile Emergency Control Centre

The AREVA MELOX plant, situated in the regional department of Gard (France), produces MOX fuel assemblies intended to power light-water reactors in different countries. MELOX is the world leader in this market, with more than 1,500 metric tons of MOX fuel produced since the plant started operation.

Mechanical, electrical and plumbing.

The European Parliament has adopted the directive amending the Alternative Investment Fund Managers Directive 2011/61/EU (AIFMD) and the Undertakings for collective investment in Transferable Securities (UCITS) Directive 2009/65/EC in the areas of delegation arrangements, liquidity risk management, supervisory reporting, provision of depositary and custody services and loan origination by alternative investment funds (AIFs) (AIFMD II). The new rules enter into force 20 days after publication in the Official Journal of the EU (OJ). Member states will have 24 months to implement AIFMD II.

The European Parliament has adopted a new Directive, to protect consumers from misleading market practices by improving product labelling and banning certain marketing habits related to greenwashing and misleading product information. These will be added to the EU list of banned commercial practices. The use of general environmental claims eg environmentally friendly, natural and eco without proof will be banned and the use of sustainability labels will be regulated meaning only sustainability labels based on official certification schemes or established by public authorities will be permitted in the EU. The Directive will also focus on goods durability by banning unfounded durability claims and the false presentation of goods as repairable, and through the creation of a harmonised label in relation to guarantee information. The Directive now needs final approval from the Council of the EU.

The European Parliament has adopted a directive, agreed with Member States, on criminalising the violation and circumvention of EU sanctions. It will introduce a common definition of, and minimum penalties for, violations. The law still needs to be formally approved by the Council of the EU before it can become law. It will enter into force 20 days after its publication in the Official Journal of the EU, after which Member States will have one year to transpose it into national legislation.

The European Parliament has adopted the Instant Payments Regulation, amending the Regulations (EU) No 260/2012 and (EU) 2021/1230 as regards instant credit transfers in euro to ensure transferred funds arrive immediately into the bank accounts of retail customers and businesses across the EU. The new rules enter into force 20 days after publication in the Official Journal of the EU (OJ). Member states will have 12 months to apply the regulation.