The Finnish Medicines Agency (Fimea) has published a guidance document consolidating the principal regulatory requirements and applicable guidelines for the manufacture of custom-made medical devices1. The document is intended for industry stakeholders and provides a structured overview of custom-made device…
Guidance document GN-00, Guidance on Definitions and Abbreviations in the Administrative System for Medical Devices, was updated on 2 October 2025 with immediate effect1. The latest change modified Section 2.42.3 to read as follows: ‘Adaptable medical device means a…
A new Technical Reference Document – TR-009, Personalised Medical Devices – has been published1 and became effective immediately. This document aims to provide definitions and examples of personalised medical devices, and to identify and describe different categories of devices that…
Understanding Regulation of Custom-Made Medical Devices, first published in 2022, was last updated in May 20251. This guidance for manufacturers and sponsors (including healthcare professionals) explains how the Therapeutic Goods Administration defines and regulates custom-made medical devices. It also outlines…
In May 2025, the guidance entitled Understanding Specified Articles and Excluded Products in Personalised Medical Devices Regulation was reformatted into the new guidance template1. The title of the guidance was changed from Refinements to the Personalised Medical Device Framework, and…
Resolution (RDC) No. 925 of 19 September 2024, which was published in the Official Gazette No. 185 of 24 September 2024, defines the requirements for the manufacture, sale, import, and exposure to use of custom-made medical devices1. This Resolution does not…
Transitional provisions for the online registration of manufacturers of custom-made medical devices who are already registered in the existing lists of the Ministry of Health have been extended1 until 1 May 2024 at the request of some trade associations. From 2…
Since 2 April 2024, customised medical devices will not be included in the scope of the Medical Device Administrative Control System (MDACS)1. The relevant definitions in GN-00, Guide to Definitions and Abbreviations in the Medical Device Administrative Control System, and…
New guidance MDA/GD/0066, Importation of Medical Device for Personal Use, has been published1 to outline the requirements for the importation of personal use medical devices. The guidance applies to all home use medical devices that fall within the definition of…
In the first quarter of 2024, the Medical Device Register (RZPRO) will be replaced fully by the Medical Device Information System (ISZP)1. This change will affect distributors, service providers and custom-made medical device manufacturers. Before the ISZP’s launch, information on…
In September 2023, the final version of Personalized Medical Devices – Regulatory Pathways1 was issued by the International Medical Device Regulators Forum (IMDRF). This guidance sets out recommendations for a harmonised approach to the application of existing regulatory pathways to…
The Decree of the Minister of Health of 9 June 20231, which was published in the Official Gazette No. 206 on 4 September 2023, identifies the methods for providing information regarding the manufacturer’s identification data and the list of types of…
Comments are being accepted until 28 August 2023 on a draft guidance document entitled, Patient-Matched Guides to Orthopedic Implants – Draft Guidance for Industry and Food and Drug Administration Staff1,2. This draft guidance provides recommendations on information that should be…
On 28 February 2023, a new guidance document (MDA/GD/0064) was published to support the notification of custom-made medical devices1. This guidance document is intended to provide guidance on the requirements for custom-made medical devices that are eligible for exemption from…
On 11 April 2023, a new technical guidance on personalised medical devices was released by the International Medical Device Regulators Forum (IMDRF). Personalized Medical Devices – Production Verification and Validation (IMDRF/PMD WG/N74)1 provides harmonised recommendations for verification and validation aspects…
Introduction Three dimensional (3D) printing offers endless possibilities for cost effectively accelerating the design, production, and delivery of patient-matched medical devices for enhancing and saving lives. Also known as additive manufacturing, 3D printing has been around for decades. However, recent…
Consultation has been held on new draft guidance concerning the notification of custom-made medical devices to the Medical Device Authority1. The draft document provides guidance on the requirements that apply to custom-made medical devices that are eligible for registration exemption…
A consultation has been opened on a new guidance from the International Medical Device Regulators Forum (IMDRF) entitled Personalized Medical Devices – Regulatory Pathways1. The closing date for submission of comments is 28 November 2022. The primary purpose of this…
Introduction We are all unique, it is the one thing we have in common. It is precisely this uniqueness that is the foundation for precision medicine, basing treatment decisions on who we are rather than the disease we have. In…
Comments are being solicited until 8 February 2022 on a discussion paper issued by the Center for Devices and Radiological Health on 3D printing medical devices at the point of care1. The discussion paper provides background information on 3D printing…
The deadline for manufacturers and sponsors to notify the Therapeutic Goods Administration of their custom-made medical devices that will be transitioning to inclusion in the Australian Register of Therapeutic Goods (ARTG) has been extended by 12 months to 25 August…
Manufacturers and importers of patient-specific medical devices must comply with the provisions for registration (Article 3 of Resolution RDC No. 3051) within 48 months2 from the entry into force of this Resolution. Previously the transition period had been 24 months1.…
The annual reporting form for custom-made medical devices was made available by the Therapeutic Goods Administration in July 20211,2. Manufacturers and sponsors of custom-made medical devices must supply an annual report detailing all the custom-made medical devices they have manufactured…
A new regulatory framework for personalised medical devices took effect on 25 February 2021, including a transition period for eligible manufacturers and sponsors until 1 November 2024. During the implementation phase several sectors have raised concerns over the impact of…
In March 2021, the Medical Device Coordination Group issued MDCG 2021-3, Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices1. This document addresses the most pertinent questions relating to custom-made devices falling under…
The Therapeutic Goods Administration (TGA) has published answers to frequently asked questions (FAQs) on the new regulatory framework for personalised medical devices1. These questions should be read in conjunction with the guidance document entitled, Personalised medical devices (including 3D-printed devices):…
Comments have been solicited on a draft regulatory guideline designed to provide clarity on three-dimensional (3D)-printed medical devices, as well as the regulatory approach and regulatory requirements for these medical devices1. The draft guideline reflects the Health Science Authority’s current…
From 25 February 2021, the following regulatory requirements, developed under the new personalised medical devices framework, will apply1: introduction of new definitions for personalised medical devices, which will result in a reduced scope of the existing definition of a…
Introduction The manufacture of medical devices is subject to strict regulatory requirements. These requirements include complying with quality management standards, assessing and mitigating risks that are inherent in production processes, and reporting adverse events involving a manufacturer’s product to regulatory…
The Medicines and Healthcare products Regulatory Agency (MHRA) continues to produce supporting guidance and information for industry, healthcare professionals and patients covering the COVID-19 pandemic. The most recent documents are as follows1: How tests and testing kits for coronavirus…
Brazil is a large country with extensive and expanding medical device regulations but, due to the influence of a new liberalist approach to economy and regulation, the pace has changed slightly over the past few years. By the end of…
On 12 December 2019, the Therapeutic Goods (Medical Devices) Regulations 2002 were amended by the Therapeutic Goods Legislation Amendment (2019 Measures No 1) Regulations 20191. The changes primarily affect software, personalised medical devices, in vitro diagnostic (IVD) companion diagnostics and…
On 24 September 2019, technical requirements for the manufacturing, marketing, import, export and exposure to use of custom-made and patient-specific medical devices were published in Resolution RDC No 3051. The requirements address, inter alia, Good Manufacturing Practices, labelling, traceability, technovigilance,…
On 4 July 2019, the National Medical Products Administration published Customized Medical Device Supervision and Management Regulations (Trial) (No 53 of 2019)1,2, which are set for implementation on 1 January 2020. The aims of these Regulations are to standardise the…
Interested parties had until 24 July 2019 to comment on a proposed document issued by the International Medical Device Regulators Forum (IMDRF) entitled Personalized Medical Devices – Regulatory Pathways1. The purpose of this guidance document is to recommend a harmonised…
Guidance has been published to assist manufacturers and regulatory representatives in preparing medical device licence applications for 3D printed medical devices1. The guidance outlines the specific evidence required to support pre-market Class III and Class IV licence applications for implantable…
A period of public consultation has been held on how personalised medical devices are regulated in Australia1. This consultation followed on from a previous consultation undertaken in 2017, which confirmed that the public supports reforms of the current regulatory requirements…
Three new technical documents have been finalised by the International Medical Device Regulators Forum (IMDRF) and posted on their website: IMDRF/Standards WG/N51 FINAL:2018, Optimizing Standards for Regulatory Use This guidance offers clear recommendations to regulatory authorities, standards development organisations…
Two new final guidance documents have been published1 by the Saudi Food and Drug Authority (SFDA): MDS-G20, Guidance on Requirements for Clinical Investigations of Medical Devices; and MDS-G30, Guidance on Patient-Matched Medical Devices Using 3D Printers. In addition, eight new draft…
Comments were accepted until 8 January 2019 on a draft guidance document concerning the licensing requirements for implantable medical devices manufactured by 3D printing1. As with all Class III and IV medical devices, devices produced by additive manufacturing (or 3D printing)…
Interested parties have until 12 November 2018 to submit comments to the National Agency of Sanitary Surveillance (ANVISA) on draft Resolution 546/2018, which establishes requirements for the manufacturing, marketing, import, export, and exposure to the use of custom-made and patient-specific…
Health Canada has announced that it is developing a draft guidance document to assist medical device manufacturers wishing to licence 3D printed (additive manufactured) devices1. This draft guidance will provide advice on evidence to support pre-market Class III and Class…
Following responses received during a public consultation, the Therapeutic Goods Administration (TGA) has decided to seek further stakeholder input on areas that were identified as requiring additional clarity before it implements any regulatory changes to personalised and 3D printed medical…
Guidance on the importation requirements for personal use and custom-made medical devices (MDS-G15) has been published by the Saudi Food and Drug Authority (SFDA)1. This guidance specifies the requirements and procedures for obtaining an importation licence and shipment clearance for…
The International Medical Device Regulators Forum (IMDRF) has launched a new Work Item concerning personalised medicine1. The purpose of this Work Item is to develop guidance that establishes definitions and regulatory pathways for Regulatory Authorities to consider in the regulation…
The Therapeutic Goods Administration (TGA) held a consultation on the future options for the regulation of personalised and 3D printed medical devices; the comment period ended on 22 December 20171. Any regulatory reforms would affect industry, healthcare professionals and patients of…
A new leapfrog guidance document has been issued to provide the Food and Drug Administration’s initial thoughts on the technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing1,2. The purpose of this…
Brazil is a large country with extensive and constantly expanding medical device regulations. This report explores the changes that are likely to have the greatest impact on companies’ regulatory strategies during 2018. Firstly, it sets out the official regulatory agenda…
Introduction The new European Medical Devices Regulation (Regulation (EU) 2017/745, MDR)1 does not assign a specific legal status to three-dimensional (3D) printing and leaves unanswered the question of the applicable legislation in relation to this practice, which undoubtedly represents the…
A proposed document has been released by the International Medical Device Regulators Forum (IMDRF) Personalized Medical Devices Working Group for public comment. The consultation on Definitions for Personalized Medical Devices will close on 24 May 20181. The purpose of this…
