Since 1 July 2025, restrictions introduced under the Industrial Chemicals Environmental Management Standard (IChEMS) prohibit the import, manufacture and use of three perfluoroalkyl and polyfluoroalkyl substances (PFAS) in Australia: perfluorooctane sulfonate (PFOS); perfluorooctanoic acid (PFOA); perfluorohexane sulfonate (PFHxS). …
On 8 August 2024, a Memorandum of Understanding was signed1 to confirm the collaboration between the Ministry of Health and all the actors involved and identified by Italy’s National Plan for the elimination of the use of dental amalgam. The…
As part of ongoing monitoring of medical devices containing cobalt, the National Agency for the Safety of Medicines and Health Products (ANSM) has established a dedicated, temporary scientific committee to evaluate medical devices containing cobalt (implants and prostheses)1. This scientific…
Resolution (RDC) No. 922 of 19 September 20241, which was published in the Official Gazette No. 185 of 24 September 2024, prohibits the manufacture, import and sale, as well as the use in health services, of thermometers and sphygmomanometers with a…
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…
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…
Interested parties had until 28 April 2024 to submit comments on the preliminary update of guidelines issued by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on the benefit-risk assessment of the presence of phthalates in certain medical…
Commission Regulation (EU) 2023/24821 has amended Regulation (EC) No 1907/2006 as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices to re-align the transitional provisions for DEHP-containing medical devices with the new deadlines introduced by Regulation (EU) 2023/607, amending Regulations…
Use of lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors, which are used in in vitro diagnostic medical devices (IVDs) for the analysis of creatinine and blood urea…
A Commission Regulation1,2 to amend Regulation (EC) No 1907/2006 as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices has been drafted to re-align the transitional provisions for DEHP-containing medical devices with the new deadlines introduced by Regulation (EU) 2023/607,…
The Directorate-General for Health and Food Safety (Unit D3 Medical Products and Innovation Medical Devices) has requested1 that the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) update the guidelines on the benefit-risk assessment of the presence of phthalates…
A voluntary Radiation Sterilisation Master File Pilot Program is being launched1 to allow companies that terminally sterilise single-use medical devices (sterilisation providers) using gamma radiation or ethylene oxide (EtO) to submit Master File(s) when making certain changes to sterilisation sites,…
The Environmental Protection Agency (EPA) has proposed two new health regulations to reduce exposure to ethylene oxide (EtO), including more stringent air emissions’ standards and additional protection for workers who are exposed to the gas used to sterilise medical devices1.…
Commission Delegated Directive (EU) 2022/16321 has amended Annex IV to Directive 2011/65/EU as regards an exemption for the use of lead in certain magnetic resonance imaging (MRI) devices. This Commission Delegated Directive renews, in part, exemption 27 listed in Annex…
Introduction The regulatory framework for medical devices, including in vitro diagnostic medical devices (IVDs), is the set of provisions that make up the technical, legal and regulatory basis that guarantees the safety, efficacy, performance and effectiveness of these products. This…
Introducción El programa regulador para equipos y dispositivos médicos, incluyendo los dispositivos médicos de diagnóstico in vitro (DMDIV), es el conjunto de disposiciones que forman la base técnica, legal y normativa que garantiza la seguridad, eficacia, desempeño y efectividad de…
The Medical Devices (Fourth Amendment) Rules, 2022 have amended the Medical Devices Rules, 2017 with respect to biological safety1. In the Fourth Schedule, Part III, Appendix II (Device Master File for medical devices other than in vitro diagnostic medical devices),…
FDA Circular No. 2022-0031 aims to ban completely the manufacture, importation, exportation, distribution, sale, offer for sale, donation, transfer and, where applicable, the use, promotion, advertising, or sponsorship of mercury-containing thermometers and sphygmomanometers along with dental amalgam capsules and liquid…
An amendment has been proposed to the Medical Devices Rules, 2017 concerning biological safety1. In the Fourth Schedule, Part III, Appendix II (Device Master File for medical devices other than in vitro diagnostic medical devices), item 7.4 (Biological safety), the…
A number of measures designed to withdraw mercury-containing health products from the market in Brazil have been approved by the National Health Surveillance Agency (ANVISA)1. Firstly, the manufacture, importation and sale of thermometers and pressure meters using a mercury column…
Amendments have been proposed to the Ordinance on the Prevention and Disposal of Waste and the Chemical Risk Reduction Ordinance (Chemikalien-Risikoreduktions-Verordnung, ChemRRV) in order to support a global reduction in the supply of mercury1, which is consistent with the objectives…
Three Commission Delegated Directives have been published1–3 concerning new specific and temporary exemptions from the substance restrictions contained in Directive 2011/65/EU. Directive 2011/65/EU restricts the use of certain hazardous substances in electrical and electronic equipment (the RoHS Directive); Annex II…
A draft Commission Delegated Directive1 has been released to amend Annex IV to Directive 2011/65/EU as regards an exemption for the use of lead in certain magnetic resonance imaging (MRI) devices. This draft Commission Delegated Directive renews, in part, exemption…
Since 1 October 2021, cobalt has been classified as a substance that is carcinogenic 1B, mutagenic 2, and toxic for reproduction 1B, pursuant to Delegated Regulation (EU) 2020/2171. Cobalt is a naturally occurring metallic element that is used in the…
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…
Resolution RDC No. 552 of 30 August 2021 establishes the conditions required for registration, manufacturing, quality control and user information for an intrauterine device (IUD) containing copper1. Chapter II, General Requirements, sets out the specifications for the IUD’s shape, dimensions,…
Resolution RDC No. 544 of 30 August 20211 establishes the general and specific requirements and testing procedures for plastic bags for the collection, storage and transfer of human blood and its components, including requirements relating to use of polyvinyl chloride…
Commission Delegated Directive (EU) 2021/884 has amended Annex IV to Directive 2011/65/EU to extend the exemption for the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems1. Directive 2011/65/EU2 restricts the use of certain hazardous substances,…
Amendments have been proposed by the European Commission to Annexes A and B to the Minamata Convention on Mercury, some of which would affect the medical device industry1. Through Council Decision (EU) 2021/727 of 29 April 2021, the Commission has…
Three Commission Delegated Directives have been drafted1–3 concerning new specific and temporary exemptions from the substance restrictions contained in Directive 2011/65/EU. Directive 2011/65/EU restricts the use of certain hazardous substances in electrical and electronic equipment (the RoHS Directive); Annex II…
On 9 July 2021, the Food and Drug Administration updated its Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol final guidance to clarify acceptance criteria for nitinol transformation temperatures when evaluating nitinol pseudoelastic properties1. The previous version of…
Resolución Exenta No. 837 of 7 May 20211 is the reference document for the implementation of the Quality Assurance Program for equipment used in public or private nuclear medicine establishments in Chile. The document establishes the quality tests, periodicity, tolerance,…
Comments are being accepted until 11 September 2021 on a draft Ministerial Decree1 implementing European Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive), as amended in 2015 and 2017.…
Comments are being accepted until 20 September 2021 on a proposal1 to implement a total ban on the manufacture, distribution, importation, exportation, sale, offer for sale, donation, transfer, and where applicable, the use, promotion, advertising or sponsorship of mercury-containing thermometers…
An amendment has been proposed to the Regulations on Approval, Notification and Review of Medical Devices to prohibit the manufacture, import, sale and use of extracorporeal circuits containing phthalates1. Phthalates often used in medical devices include di(2-ethylhexyl) phthalate (DEHP), dibutyl…
Regulatory authority The Ministry of Health and Prevention (MoHAP) is responsible for the administration of medical device regulation in the United Arab Emirates (UAE). The Ministry oversees evaluation, classification, registration, and licensing of all medical devices, including in vitro diagnostic…
The unique properties of nitinol have prompted the Food and Drug Administration to issue new guidance1,2 outlining the specific technical considerations for devices that have at least one patient contacting component comprised of nitinol. The guidance provides clarity and consistency…
Use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems will be permitted until 30 June 2026 according to a proposed Commission Delegated Directive1. This extension applies to the exemption from Directive 2011/65/EU on the restriction of…
To meet its obligations under the Minamata Convention1, New Zealand has announced a proposal to prohibit the use of mercury-containing medical devices, particularly thermometers and sphygmomanometers2. Proposed regulatory changes under the Waste Minimisation Act 2008 would ban the manufacture and…
Use of lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors, which are used in in vitro diagnostic medical devices for the analysis of blood and other body fluids…
Bangladesh has proposed new rules for the handling of waste electrical and electronic equipment (WEEE), including medical equipment1, that it hopes to implement in 2020. It has also drafted threshold limits for use of certain hazardous substances in electrical and…
Introduction Nitinol is an alloy of nickel and titanium with major applications in the medical device industry due to its unique pseudoelasticity and shape memory behaviour. Nitinol has been used extensively in cardiovascular stents, heart valves, guidewires, etc, as well…
At the end of November 2019, the Food and Drug Administration (FDA) announced the next steps in its ongoing efforts to advance innovation in medical device sterilisation with ethylene oxide (EtO). The Agency has released the results of its two…
Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has issued a final version of Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which…
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…
A draft guidance document entitled Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol has been published1,2 to set out proposed recommendations for what manufacturers should include in their pre-market submissions for devices containing nitinol (an alloy of nickel…
Interested parties had until 29 April 2019 to comment on the European Commission’s Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have…
Di (2-ethylhexyl) phthalate (DEHP) is a plasticiser largely used in medical devices for its excellent flexibility properties. In particular, DEHP is incorporated into tubing, bags and catheters, which are often installed in larger electronic medical devices (e.g. medical imaging devices).…
In order to meet its obligations under the Minamata Convention1, Malaysia has announced a policy for phasing out the use of mercury-containing medical devices, particularly thermometers and sphygmomanometers2. The importation, exportation and manufacture of mercury-containing medical devices must be phased…
