The ‘Legacy Devices’ feature was activated in the [unique device identification] UDI Devices module of swissdamed on 5 February 20261. This new feature allows legacy devices – devices under the old legislation according to Article 101 of the Medical Devices…
Medical devices, systems and procedure packs The registration of medical devices, systems, and procedure packs in accordance with Article 108 of the Medical Devices Ordinance (MepV) will become mandatory in swissdamed on 1 July 2026, with a transitional period until…
Mandatory use of four EUDAMED modules for medical devices will begin on 28 May 20261. The transition periods for these modules, where applicable, are as follows: Actor Registration: requirements apply to manufacturers, Authorised Representatives, importers, and system and procedure…
With the entry into force of Section 374a of Book Five of the German Social Code (SGB V), manufacturers of assistive devices and implants will be responsible1, from 1 July 2027, for offering interoperable interfaces so that collected health data can…
The Food and Drug Administration (FDA) has published a final guidance entitled, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices1,2. The purpose of this guidance is to clarify how the FDA evaluates real-world data (RWD) to determine…
The registration of products, systems and treatment units will become mandatory in swissdamed from 1 July 2026, with a transition period until 31 December 20261. The product registration requirement in swissdamed will therefore come into effect in Switzerland approximately one…
The first revision of Medical Device Coordination Group MDCG 2025-7, MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles, was issued in December 2025. Revision 1 includes…
Commission Decision (EU) 2025/2371, which was published on 27 November 2025, confirms that the first four modules of the European Database on Medical Devices (EUDAMED) have achieved functionality and meet the required functional specifications1. To ensure legal certainty and a…
The Center for Devices and Radiological Health (CDRH) is seeking input from interested parties and the public on best practices, methodologies, and approaches for measuring and evaluating real-world performance of artificial intelligence (AI)-enabled medical devices1. This includes approaches to detect,…
At the Medical Device Coordination Group (MDCG) plenary meeting on 24 September 2025, the European Commission presented an updated status of the development of EUDAMED1. The new timetable means that mandatory use of the first four modules – Actor, UDI/Device,…
The first module of swissdamed – the Swiss database for registering economic operators and medical devices, including in vitro diagnostics, on the Swiss market – went live on 6 August 20241. This first module (the Actors module) enables economic operators…
The first module of the swissdamed medical devices database for the registration of companies and economic operators (ACT module) will become active on 6 August 20241. Applications for the registration of, and changes to, the Swiss Single Registration Number (CHRN),…
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…
Overview The European database on medical devices (EUDAMED) is considered the digital backbone for the European Union’s (EU’s) regulatory framework for medical technologies – Regulation (EU) 2017/745 on medical devices (MDR)1 and Regulation (EU) 2017/746 on in vitro diagnostic medical…
Comments are being sought on a draft guidance1,2 that clarifies how the Food and Drug Administration (FDA) evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA…
A new regulation for the establishment of a national register for prosthetic breast implants was published in the Official Gazette on 18 January 2023 and entered into force on 2 February 20231. This makes Italy the first country in the…
In March 2023, the listing database (register) of medical devices including in vitro diagnostics (IVDs) was published on the Botswana Medicines Regulatory Authority website1. Devices listed in the database will be subject to regulatory processes such as vigilance reporting, post-market…
The Food and Drug Administration is seeking public comment on advancing Real-World Data and Real-World Evidence (RWE) with user fee funding1. A public docket (FDA-2023-N-0156) has been opened for stakeholders to provide specific comments on how the Agency should use…
The US medical device ecosystem The medical device ecosystem in the USA consists of a spectrum of stakeholders including device manufacturers, regulators, patients, health systems, clinicians and payors. The US Food and Drug Administration (FDA) oversees the regulation of the…
A recent review was conducted into the use of real world evidence (RWE) and patient reported outcomes (PROs) in the regulation of medicines and medical devices in Australia, which took into account stakeholders’ understanding of what RWE and PROs are,…
Announcement No. 77 of 2020, dated 26 November 2020, concerned the publication of Technical Guidance on Real-World Data for Clinical Evaluation of Medical Devices (Trial Implementation)1. This guidance aims to standardise the use of real-world data in the clinical evaluation…
On 8 July 2020, a report1 of the Independent Medicines and Medical Devices Safety Review made numerous recommendations for improving patient safety in the UK. The report highlighted the need for substantial reform of the Medicines and Healthcare products Regulatory…
Ministerial Resolution No. 395-2020-MINSA, published on 17 June 2020, sets out the details of a draft regulation on changes to the health register for medical devices and in vitro diagnostics1. The draft regulation specifies the differences between minor changes and…
A period of public consultation has been held on Real-world data for medical devices - Technical Guidelines for Clinical Evaluation (Draft for comments)1. The purpose of these draft guidelines is to standardise and guide the use of real-world data in…
Germany’s Federal Cabinet has passed a draft law for the introduction of a German implant registry (Gesetz zur Errichtung eines Implantateregisters Deutschland, EIRD)1, which will have its ongoing operation funded by fees. In order to ensure the completeness and usefulness…
A new law has been drafted that, if implemented, would obligate healthcare institutions, patients and manufacturers of implantable medical devices to participate in a German Implant Register (EDIR)1. All implantable medical devices would have to be listed in a device…
The Spanish Agency for Medicines and Health Products (AEMPS) and the Spanish Society of Cardiology have launched an online platform called CardioDispositivos to maintain a national registry of pacemakers and implantable cardioverter defibrillators (ICDs)1. The registry records will be used…
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…
New guidance from the Food and Drug Administration (FDA) clarifies how the Agency evaluates real-world data to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory…
On 23 May 2018, the National Health Surveillance Agency in Brazil (ANVISA) will launch a new National Implant Registry (Registro Nacional de Implantes, RNI)1. This Registry will be an information system for recording surgical procedures for the implantation of osteoarticular…
