United States Pharmacopeia (USP) General Chapter <665>, Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, comes into force on 1 May 20261. It deals with the chemical characterisation of plastic components and…
A public consultation has been held1 on proposals for new criteria for the eco-labelling of medical devices made of plastic or silicone under the Nordic Swan Ecolabel, a voluntary eco-labelling scheme for the Nordic countries (Denmark, Finland, Iceland, Norway and…
New final guidance has been published by the Food and Drug Administration (FDA) entitled, Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices1,2. This guidance forms part of the FDA’s efforts to help maintain patient access…
International Workshop Agreement (IWA) 48:2024, Framework for implementing environmental, social and governance (ESG) principles (Edition 1), was published in November 2024 by the International Organization for Standardization (ISO)1. Its development was a collaborative effort by national standards bodies including the…
Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC, was published in the Official Journal on 22…
The European Chemicals Agency (ECHA) and authorities from Denmark, Germany, the Netherlands, Norway and Sweden have released a progress update on the process to restrict per- and polyfluoroalkyl substances (PFAS) in Europe, opening up possible exceptions in the area of…
The Medical Device Coordination Group (MDCG) has released MDCG 2024-131 to summarise the regulatory status of ethylene oxide (EtO) intended for the sterilisation of single-use medical devices during their manufacturing process, which has been discussed in relation to the Review…
The European Commission has released guidelines1 to facilitate the harmonised application of the provisions on the removability and replaceability of portable batteries and light means of transport (LMT) batteries in Regulation (EU) 2023/1542, which entered into force on 17 August…
Commission Notice C/2024/46751 has been published to facilitate the application of Regulation (EU) 2024/18492 as regards dental amalgam and other mercury-containing products subject to export, import and manufacturing restrictions to, and in, the UK in respect of Northern Ireland. Regulation…
Introduction MedTech Europe is the trade association for the medical technology industry of medical devices, diagnostics, and digital health technologies that operate in the European market1. Its yearly forum is an insightful event where the latest policy and regulatory developments…
Introduction The global medical device market has grown increasingly over the years and is projected to hit a staggering US$800 billion by the year 20301. This massive growth in the industry, which is undoubtedly due to its strategic importance in…
According to Regulation (EU) 2024/1849, from 1 January 2025, dental amalgam may not be used for dental treatment in the Union, except when deemed strictly necessary by the dental practitioner based on the specific medical needs of the patient1. The…
In June 2024, an update was published1 of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices that are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties. Only minor changes were…
The Ministry of the Environment has announced that the implementation of producer responsibility for packaging will be postponed from 1 July 2025 to 1 October 20251. This delay will give municipalities and manufacturers more time to adapt to the new…
The Ministry of the Environment has changed the timetable for the implementation of producer responsibility for packaging from 1 January 2025 to 1 July 20251. The start date for reporting the quantities of packaging that companies expect to market has…
The E-Waste (Management) Rules, 2022 came into force on 1 April 2023 and apply to every manufacturer, producer, refurbisher, dismantler and recycler involved in the manufacture, sale, transfer, purchase, refurbishing, dismantling, recycling and processing of electronic waste or electrical and…
On 1 July 2023, India’s new rules on plastic waste management took full effect and these rules have an impact on the medical device industry1,2. The rules refer to Extended Producer Responsibility, which means the responsibility of a producer (manufacturer)…
Introduction Sustainability is not a new concept. For some time, medical technology companies have been working on several sustainability related issues (e.g. packaging waste, affordability), yet new systemic perspectives and challenges are emerging. Medical technology companies, like all companies worldwide,…
On 1 January 2023, the Supply Chain Due Diligence Act (Lieferketten-Sorgfaltspflichtengesetz, LkSG) entered into force in Germany1. This Act applies to all companies that employ more than 3,000 people in Germany; from 1 January 2024, it will apply to more…
The growing importance of climate concerns and the role and responsibility of industry in international initiatives is stimulating greater interest in the fundamental environmental properties and characteristics of products than previously. Until recently, attention concentrated on environmental management systems described…
Decree No. 2021-1176 of 10 September 2021 has been published in relation to the management of waste from electrical or electronic equipment associated with perforating/piercing medical devices used by patients in self-treatment and self-testing (e.g. continuous glucose monitoring sensors)1. In…
Introduction Manufacturers of medical devices placed on the market with the CE mark under the European Directives are fully acquainted with the safety and performance their products must fulfil. These requirements, defined in the form of fundamental Essential Requirements in…
On 30 May 2019, the Illinois General Assembly passed Senate Bills 1854 and 1852 addressing sources of ethylene oxide emissions. Governor Pritzker signed these two bills into law, as Public Act 101-00221 and Public Act 101-00232 respectively, on 21 June…
Introduction Medical care is vital for life and the health of human beings, but waste generated from medical activities and production of medical devices represents a real problem to the natural and human world. Every day, relatively large amounts of…
