In December 2023, a first revision of MDCG 2019-07, Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC), was released1. Changes have been made…
To help manufacturers of medical devices and in vitro diagnostics (IVDs) understand the language requirements for the information and instructions that accompany a device in a specific country, the European Commission and Member States have created tables1 that provide an…
A new Decree on the fees charged by the Finnish Medicines Agency (Fimea) has been published1 to replace Ministry of Social Affairs and Health Decree 798/20222. The new Decree took effect on 1 January 2024 and is expected to remain in…
Comments were accepted until 26 January 2024 on a draft guide for health institutions who manufacture and use in-house in vitro diagnostic medical devices (IVDs) in Ireland1. The purpose of this guide is to help health institutions and medical laboratories…
Since 26 October 2023, it is possible to enter information1 in the national database of medical devices relating to systems and procedure packs (Article 22, paragraphs 1 and 2 of Regulation (EU) 2017/745 (MDR)) and relating to changes introduced by…
Since 1 January 2024, the Norwegian Medicines Agency has assumed more tasks and a greater responsibility, especially relating to supply security and emergency preparedness, procurement, and public financing of medical products. The Agency has become a Directorate and will be…
A notification1 was issued in December 2023 regarding the additional marking of medical devices and in vitro diagnostics (IVDs) during the transition period that applies for transitioning from Directives 90/385/EEC, 93/42/EEC and 98/79/EC to Regulations (EU) 2017/745 and (EU) 2017/746.…
A reorganisation of Swissmedic, the Swiss Agency for Therapeutic Products, has separated responsibilities for medical device market surveillance from those for medicinal products1. The new Medical Devices Surveillance Sector is responsible for the safety of clinical trials, materiovigilance and market…
In November 2023, Swissmedic revised its information on submitting vigilance reports1 – incidents, trend reports and Field Safety Corrective Action reports – for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical…
On 1 November 2023, new legal requirements became applicable in Switzerland for products without an intended medical purpose1. Products without an intended medical purpose must now fulfil the Common Specifications and the General Safety and Performance Requirements set out in…
The US Food and Drug Administration (FDA), Health Canada, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified five Guiding Principles for pre-determined change control plans (PCCPs)1. Internationally, the medical device community is discussing the use…
During the first half of 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) intends to hold discussions with stakeholders on the UK’s future core regulations to give early sight of the detailed policy, developed from the policy positions in…
The Fees in Respect of Drugs and Medical Devices Order has been amended to specify the new fees for medical device applications that will apply from 1 April 20241. Details of the fees that will apply from 1 April 2024…
The Health Products and Food Branch of Health Canada has decided to proceed with implementation of the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities1. Its decision was based on…
The Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) were adopted on 19 December 2023 and published on 3 January 20241. These amendments to the Medical Devices Regulations broaden the scope of Part 1.1,…
On 4 December 2023, Health Canada revised the medical device establishment licence (MDEL) application form and its accompanying instructions for completion (FRM-0292)1. The MDEL application form is used to apply for a new MDEL, apply for an MDEL after a…
Health Canada has clarified the details of the annual licence review (ALR) for 20241. Holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before 1 April, according to section 46.1 of…
The White House has issued an Executive Order on artificial intelligence (AI)1 to promote the safe development of this growing technology. This Executive Order requires developers to share the results of safety tests before new AI systems are publicly released,…
The container system for the processing and storage of red blood cell components under reduced oxygen conditions has been classified1 into Class II (special controls) in response to a de novo classification request. The Food and Drug Administration has taken…
Comments are being accepted until 28 February 2024 on a proposal1 to classify certain unclassified, pre-amendments wound dressings and liquid wound washes containing antimicrobials and/or other chemicals into three separate classification regulations: solid wound dressings, where the intended use…
Final guidance has been published to set out the Food and Drug Administration’s (FDA’s) enforcement policies for clinical electronic thermometers1,2. The guidance describes enforcement policies for certain legal requirements for clinical electronic thermometers, including those with and without telethermography or…
Final guidance entitled Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring has been published1,2. The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring…
Final guidance for industry entitled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations was issued on 21 December 20231,2. This guidance provides recommendations for ensuring that a digital health technology (DHT) is fit for purpose (i.e. that the…
Final guidance has been issued for industry and Food and Drug Administration staff on assessing the credibility of computational modelling and simulation (CM&S) in medical device submissions1,2. CM&S can be used in a variety of ways in medical device applications,…
The Food and Drug Administration (FDA) has released1 the final guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the [Food, Drug and Cosmetic] FD&C Act2 and the draft guidance…
Immediately-in-effect guidance has been released1,2 concerning the Food and Drug Administration’s (FDA’s) enforcement policy for certain supplements to approved pre-market approval (PMA) or humanitarian device exemption (HDE) submissions. The guidance provides recommendations for limited modifications affecting the safety or effectiveness…
As part of its efforts to support device sponsors as they address cybersecurity concerns, the Food and Drug Administration (FDA) has fully recognised1 the key consensus standard ANSI/AAMI SW96:2023, Standard for medical device security – Security risk management for device…
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…
Comments are being accepted until 20 February 2024 on a draft guidance entitled 510(k) Third Party Review Program [3P510k] and Third Party Emergency Use Authorization (EUA) [3PEUA] Review1,2. When finalised, this draft guidance will update the previously issued 510(k) Third…
Comments are being accepted until 25 March 2024 on draft guidance1,2 concerning the characterisation of metallic coatings and/or calcium phosphate coatings on orthopaedic devices. This draft guidance provides recommendations for pre-market submissions for orthopaedic devices that contain metallic coatings and/or…
Comments have been solicited on a revised draft guidance for industry entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers1-3. Specifically, this revised draft guidance relates to companies…
Since 2 January 2024, the Food and Drug Administration (FDA) will only issue electronic export documents for medical devices rather than paper documents1. Switching to electronic PDF documents improves efficiency in issuing export documents, reduces the amount of time it…
Guidance entitled Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices – Guidance for Industry and Food and Drug Administration [FDA] Staff has been updated1. The updated guidance includes minor changes to align…
The electronic Submission Template and Resource (eSTAR) is now available for voluntary use for the following pre-market approval application (PMA) submission types1: original PMAs; PMA panel track supplements; PMA real-time supplements; PMA 180-day supplements. eSTAR is an interactive…
The Center for Devices and Radiological Health’s Customer Collaboration Portal (CDRH Portal) has been updated to help users track the progress of their de novo classification requests1. The latest portal updates are also intended to improve the user experience by…
On 8 January 2024, the Food and Drug Administration (FDA) announced that it considers vaporised hydrogen peroxide (VHP) to be an established method of sterilisation for medical devices1. Methods with a long history of safe and effective use on medical…
On 18 December 2023, the Food and Drug Administration (FDA) updated1 its medical device shortages list to remove the following from the list: chest drains, suction canisters, and chest drains with autotransfusion indications (product codes KDQ and CAC); tracheostomy…
In January 2024, ANMAT Provision 2/20241 modified the fees charged by the National Administration of Drugs, Food and Medical Technology (ANMAT) for the activities it undertakes with respect to medical devices and in vitro diagnostic medical devices (IVDs). A full…
On 8 November 2023, Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) and Brazil’s National Health Surveillance Agency (Anvisa) signed a mutual recognition agreement1 on Certificates of Free Sale and Certificates for Foreign Countries for medical devices in…
Draft Resolution No. 734 of 22 October 2019, which proposed the updating of Resolution RDC No. 36 of 26 August 2015, which establishes the risk classification, control scheme of notification, registration, market authorisation and technical requirements for labelling and usage instructions…
Draft Resolution No. 1123 of 27 October 2022, which contained provisions pertaining to the performance of clinical trials with medical devices in Brazil, was adopted as Resolution RDC No. 837 of 13 December 20231. This Resolution came into force on the…
Anvisa – Brazil’s National Health Surveillance Agency – has invited interested companies to participate in a pilot project designed to support the development of innovative medical devices1,2. During this pilot, Anvisa will analyse the risks posed by the innovative device…
An update of the standards used for sanitary control and verification of the conformity of hypodermic, sterile and single-use needles and syringes, as previously established in Ministry of Health Exempt Decree No. 1887 of 27 December 2007, has been proposed1.…
A regular update of the National Institute for Food and Drug Surveillance’s (Invima’s) Tariff Manual1 was carried out on 1 January 2024 and included the following changes: In compliance with the provisions of Article 313 of Law 2294 of…
On 10 November 2023, a partial amendment of the substitute sanitary Technical Regulation on the sanitary registration and control of medical devices for human use and of the establishments that manufacture, import, dispense, sell or market such devices, entered into…
In an unprecedented move to improve transparency and end the era of opacity that has predominated obtaining marketing authorisations for medical devices in Mexico, the Federal Commission for the Protection against Health Risks (Cofepris) has published a guide1 for obtaining…
Interested parties had until 20 January 2024 to comment on Nicaraguan Mandatory Technical Standard (NTON) No. 24001:2023, Health technology. Medical devices. Sanitary registration requirements1. This draft standard establishes the requirements and provisions for the sanitary registration of medical devices for…
If a country only issues Certificates of Free Sale (CFSs) in digital format, certain rules need to be followed before those certificates will be accepted in Panama1. Manufacturers must print out the CFS that was provided to them digitally and…
On 25 November 2021, the reclassification of certain medical devices to align with Regulation (EU) 2017/745 on medical devices (MDR) came into effect. Transitional arrangements are in place to allow eligible Australian Register of Therapeutic Goods (ARTG) entries to be…
The following five guidance documents have been updated recently by the Therapeutic Goods Administration (TGA): TGA quality management system audits and certification – Guidance for manufacturers of medical devices (version 2.0, December 2023)1 This guidance provides information for medical…
