Mhra medical device alerts database

Mhra medical device alerts database. 9 May 2024. 5. so they are confident in being able to use any new devices (see further Nov 30, 2023 · AstraZeneca UK Ltd. Guidance and regulation Jun 18, 2024 · Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for Jun 29, 2017 · MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018) Apr 2, 2012 · The MHRA has also advised surgeons to closely monitor patients with this combination of implants. uk and requesting this facility. uk Aug 30, 2012 · I am requiring the Adverse event database for MEDICAL DEVICES. Jan 7, 2021 · Governance. Background The advice is included in a new MHRA Medical Device Alert, which can be found here. g. , COVID-19 test), it may be longer. In accordance with 21 CFR Part 803, manufacturers and importers must submit reports when they become aware of information that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or Dec 18, 2014 · See the How to register for MHRA Portal and RamaXL (PDF, 700 KB, 11 pages) for extra help. Once the medicines safety officers and medical device safety officers have been identified by the organisations required to act on the alerts, these individuals and the newly formed networks will enormously increase our ability to improve safety by broadening our reach and establishing channels for sharing and feedback. Sep 23, 2019 · The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. Feb 14, 2024 · Alerts, recalls and safety information: drugs and medical devices; Field Safety Notices: 5 to 9 February 2024 MHRA reference: 27931662. Please visit the new site at: PARD (mhra. Alert type: Field safety notice Issued: 5 August 2024 Nov 9, 2021 · Following our latest review of medical device alerts, we have archived the ones listed below. MHRA reference Aug 3, 2023 · Once manufacturers and/or UKRPs have registered themselves and their devices with MHRA, registrants’ name, address, and device information are added to the Public Access Database for Medical Device Registration. We would like to show you a description here but the site won’t allow us. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. List of featured recalls and alerts updated. MHRA uses terminology to describe devices and classification per the There’s a different way to report a problem with a medical device if you’re in Wales, Scotland or Northern Ireland. News. This guidance provides information on the UK system, including National Patient Safety Alert - DHSC: 03-May-2024: Issued: CEM/CMO/2024/002: Influenza season 2023/24: ending the prescribing and supply of antiviral medicines in primary care: CMO Messaging: 02-May-2024: Issued: NatPSA/2024/004/MHRA: Reducing risks for transfusion-associated circulatory overload: National Patient Safety Alert - MHRA: 04-Apr We have launched a new version of the Public Access Registration Database (PARD). NatPSA/2023/004/MHRA. Medical Devices Notifications (public part) includes the notifications on the first placing medical devices on the market (according to § 25 MPG / § 96 MPDG). 30 In vitro diagnostic Medical Device & Accessories. The MHRA is taking a The objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy of medicines available in Ireland and to participate in systems designed to do that throughout the European Union. Therefore, it is not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions Mar 19, 2020 · The MHRA is working closely with DHSC and other healthcare partners on COVID-19. This timeframe may be shorter for registrations that have only 1-2 device families, or for well-established products. Problem Action Delays in acting on Field Safety Notices (FSNs) can compromise patient safety. E-cigarettes and e-liquids Any adverse incident involving a nicotine e-cigarette or refill container (e-liquid) should be reported. Database de­scrip­tion for AM­Ice Batch Re­lease; Database de­scrip­tion for AM­Ice Sub­stances; Database de­scrip­tion for AM­Ice Terms of Sub­stances; Database de­scrip­tion for AM­Ice Medic­i­nal Prod­ucts; Pharm­Net. The database is part of the German database-supported medical devices information and database system. Public Access Database for Medical Device Registrations. To overview: Medical devices; Reg­u­la­to­ry frame­work. email to: safetyalerts@mhra. Where appropriate, the medical devices management group should include links with specialist groups dealing with specialised medical devices (for example laboratories, radiology and renal dialysis). 33 IVD Medical Device Post market surveillance. All national patient safety alerts need executive level oversight (or equivalent in organisations without executive boards) of governance systems that provide evidence that the required actions have been fully completed before any National Patient Safety Alert is recorded as action completed on the Central Alerting System (CAS). Search the database to: verify the licence status of a medical device; find product specific information on a medical device A Periodic Safety Update Report (PSUR) is a document which provides an evaluation of the risk-benefit balance of the medicine at defined times following authorisation. Enquiries England Send enquiries about this notice to MHRA, quoting reference number MDA/2020/020 or 2019/011/013/291/013. Apr 1, 2014 · It is intended for people in hospitals and community-based organisations that are responsible for the management of reusable medical devices. Ref: MDA/2014/037 Issued: 26 September 2014 at 14:00 . News stories, speeches, letters and notices. MHRA alerts are defined within . Updated file 'Medical device stand-alone software including apps (including IVDMDs)' to reflect that the Government has made regulations that enable CE marked medical devices to Jun 23, 2021 · Date of issue: 23 June 2021. Skip to results. Jan 9, 2024 · Alerts, recalls and safety information: drugs and medical devices; Field Safety Notices (FSNs) from 1 to 5 January 2024 MHRA reference: 27763197. Added a section on Medical Device Alerts (MDAs) related to coronavirus (COVID-19) 9 April 2020. Oct 16, 2015 · List of Field Safety Notices from 29 July to 2 August 2024. • User modifications of devices other than directed by the device manufacturer. To to reproduce or re-use any MHRA material see our guidance. Single-use medical devices: leaflet. Patient information leaflets and summaries of product characteristics. Basic search functionality allows searches by Medical Device Type or Manufacturer Name. Assistive technology: definitions, examples and safe use - Section 10 includes links to guidance on bed rails, wheelchairs in transport and hoists. Departments, agencies and public bodies. Updates to this page Published 1 April 2014 Registration of medical devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA. The Central Alerting System (CAS) and the role of medical device liaison officers (MDLOs) The Central Alerting System is the medium through which MDAs are issued to the NHS. Medical Device Alert Action update Ref: MDA/2010/001 Issued: 04 January 2010 at 11:00 Device Medical devices in general and non-medical products. Problem Action • Off-label use of medical devices. . 1: Developing the NRLS as an integrated reporting route for medical device EMA is responsible for maintaining a rapid alert list of contact points, which includes national competent authorities in EEA Member States, the European Commission and international partner regulatory authorities and organisations. Jan 1, 2021 · The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator. Thank You I have had a look on the TGA, MHRA website but no luck! National Health Regulatory Authority; Al Khair Tower 2, Building 612, Road 1011, Block 410, Sanabis; P. Bund; Med­i­cal de­vices. Do not use the device if you suspect it is counterfeit. Emollients and risk of burns. Manufacturers, importers and distributors must continue to comply with GMP/GDP and all other legal obligations. PL 33616/0015. Therefore, it is not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions 5 days ago · 1. Yellow Card centres. Government activity Departments. 020 3080 7272 (manned 10:00-16:00 Report a problem with a medicine or medical device Alerts, recalls and safety information: drugs and medical devices. Technical aspects Email: DSS-TM@mhra. UK. The The MHRA products website allows you to find: The leaflets which are provided with medicines; The description of the medicinal product’s properties and how it can be used; Scientific reports about marketing authorisations for medicines; You can look for any word, phrase or Product Licence number (PL) using the search tool. Search Filter results. Find alerts and recalls issued by MHRA Cookies on GOV. Enquiries email to: safetyalerts@mhra. Apr 7, 2022 · 29 August 2024. Adverse reactions to drugs | Medicines guidance | BNF content published Dec 31, 2020 · In vitro diagnostic medical devices registered as undergoing performance evaluation study are not published on this database. You can search with keywords and set medical speciality, alert type and search timeframe. From: Medicines and Healthcare products Regulatory Agency May 20, 2020 · MHRA keeps information from manufacturers on proposed field safety corrective actions (FSCAs), including draft copies of FSN, confidential as required by the Medical Devices Regulations (SI 2002 Dec 18, 2014 · 17 May 2024 'Medical devices: the regulations and how we enforce them' updated to reflect changes to the legislation relating to MHRA’s investigatory and enforcement powers. From: Medicines and Healthcare products Regulatory Agency Published 9 November 2021. uk) Dec 17, 2014 · MHRA often has to issue Medical Device Alerts (MDAs) reminding users about manufacturers’ FSNs where there is insufficient feedback that it has reached the appropriate people and been acted upon Aug 30, 2023 · The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Drug Safety Update - stay up to date with emerging news and MHRA guidance. These alerts are sent to the NHS in England. MHRA normally supports this action by issuing a Medicines Recall/Notification to healthcare professionals. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. Is there anywhere I can access this data for UK, EU and Australia which is similar to MAUDE. For any queries involving counterfeit or fake medical devices contact devices. Methods The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory Feb 6, 2023 · Alerts, recalls and safety information: drugs and medical devices; Field Safety Notices: 30 January to 3 February 2023 List of Field Safety Notices (FSNs) from 30 January to 3 February 2023 CDRH Databases: a listing of databases for such topics as advisory committees, regulations, good practices, medical devices, Premarket Approval (PMA) and Notification (510(k)), product codes May 28, 2014 · View a map showing our location. gov. Dec 18, 2023 · The MHRA quotes 5 days to review and process medical device registrations. Included therein is mainly administrative data and further data relevant to Medical Device Post market surveillance. Jun 20, 2022 · Sign-up to receive MHRA alerts about drugs and medical devices and subscribe to Drug Safety Update. 4 MHRA Drug Alerts . uk Telephone: 020 3080 7171 Monday to Friday, 9am to 5pm Find out about Jun 27, 2022 · Alerts, recalls and safety information: drugs and medical devices (FSNs) from medical device manufacturers from 20 to 24 June 2022. O. Filter. uk Clinical aspects Devices Clinical Team, MHRA Summaries of information about the most serious medical device recalls. To overview Medical Device Alerts (MDAs) MDAs are the MHRA’s prime means of communicating important safety information to medical device users in health and social care. Therefore, it is not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions MHRA Homepage for reporting of suspected side effects or adverse drug reactions to any medicines or vaccines, as well as medical device incidents Feb 11, 2019 · In 2022, the MHRA undertook a review of the restrictions in place for these anti-choking devices, which considered multiple factors including: the progress made by the manufacturers since the Sep 27, 2011 · The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for laryngoscope handles produced by all manufacturers, including all model numbers. Dec 27, 2018 · Medical Devices Active Licence listing online query. 2. MHRA CFS team device. drugs and medical devices. Feb 5, 2024 · Following a review, the MHRA has updated previous guidance (DSI/2022/003) on the use of paclitaxel coated devices (PCD) in the treatment of peripheral arterial disease (PAD). Enquiries England Send enquiries about this notice to MHRA, quoting reference number MDA/2020/019 or 2019/003/019/468/002 Technical aspects Alexander McLaren, MHRA Tel: 020 3080 6000 Email: DSS-TM@mhra. MHRA Managing Medical Devices January 2021 Page 6 of 46 • purchasing • medical device trainers • medical device users • MDSOs. uk. cfs@mhra. Updates to this page Mar 25, 2024 · The MHRA is working with online marketplaces to remove unbranded and counterfeit anti-choking devices from sale. uk Clinical aspects Devices Clinical Team, MHRA Tel: 020 3080 7274 Jul 1, 2023 · An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Devices Regulations For counterfeit or fake medicines or medical devices, including coronavirus testing kits, report as usual on the Yellow Card site. The information is about safety concerns which do not meet MHRAs criteria for a national patient safety alert. Jan 16, 2024 · The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a new roadmap setting out its timeline for an overhaul of the UK medical device regulations. Dec 18, 2014 · Therefore, the Medical Device Regulation (EU) 2017/745 (MDR) and the in vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) will apply in Northern Ireland from 26 May 2021, and 26 May Dec 31, 2020 · Overview. We use some essential cookies to make this website work. The alert has been issued to clinicians today for the management of patients the Mitch TRH cup/heads, made by Finsbury Orthopaedics, used in combination Alerts Recalls Other Safety Related Information; United Kingdom: National Patient Safety Alerts: Alerts and recalls for drugs and medical devices Alerts and recalls for drugs and medical devices - 153 alerts for Field safety notice: Medical devices regulation and safety - Latest documents: Japan: Safety Information regarding Medical Devices Jan 28, 2015 · Bookmarks and saved links to MHRA’s old website will still take you to the information you need. like our safety alerts and guidance on applications by using the same web links you currently Nov 17, 2023 · Alerts, recalls and safety information: drugs and medical devices; Field Safety Notices: 6 to 10 November 2023 MHRA reference: 27483084. Main telephone (weekdays 9am to 5pm): 020 3080 6000. PL Number. The Medicines and Healthcare products Regulatory Agency MHRA Device Safety Information (MDSI) MDSIs capture safety information from MHRA. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Alerts, recalls and safety information from MHRA. compliance@mhra. Urgent: to be cascaded within 24 hours . National Patient Safety Alert - DHSC: 03-May-2024: Issued: CEM/CMO/2024/002: Influenza season 2023/24: ending the prescribing and supply of antiviral medicines in primary care: CMO Messaging: 02-May-2024: Issued: NatPSA/2024/004/MHRA: Reducing risks for transfusion-associated circulatory overload: National Patient Safety Alert - MHRA: 04-Apr Registration of medical devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA. 32 IVD Design and Manufacturing requirements. 9 July 2024. PL 33616/0014. Non-Urgent: to be cascaded within Nov 7, 2016 · Contact the Medicines and Healthcare products Regulatory Agency (MHRA) if you need help. Therefore, it is not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions Description of the MAUDE Database. Feb 12, 2021 · The MHRA is accredited to publish National Patient Safety Alerts (NatPSA) for medical devices and medicines. Other regulators and countries may be notified of a recall by the issue of a Rapid Alert notification. 0 Oct 31, 2023 · Alerts, recalls and safety information: drugs and medical devices; Field Safety Notices: 23 to 27 October 2023 MHRA reference: 27492800. 31 IVD Essential Requirements - General. uk Clinical aspects Devices Clinical Team, MHRA Tel: 020 3080 7274 Email: dct@mhra. Box 11464 Manama, Kingdom of Bahrain; Tel: +973 17 113 333, Fax: +973 17 113 270 Sep 16, 2021 · The MHRA will therefore proceed with preparing regulations reclassifying products such as certain implantable devices, extending the scope of regulations to capture certain non-medical products 5. uk) Apr 11, 2022 · Alerts, recalls and safety information: drugs and medical devices (FSNs) from medical device manufacturers from 4 to 8 April 2022. You can register up to 7 people for free (including training for 2) and then pay for additional people Aug 8, 2014 · 1 July 2023. The Public Access Registration Database. This alert is for action by: all Hospital Trusts and Health Boards providing NHS and private healthcare, including community care. Therefore, it is not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions Aug 30, 2022 · MHRA. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. Alerts, recalls and safety information: medicines and medical devices; Drug Safety Update; Yellow Card: Report a problem with a medicine or medical device; Marketing authorisations and Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products to the Medicines and Healthcare products Regulatory Agency May 25, 2022 · The Central Alerting System (CAS) is a web-based cascading system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the Jan 26, 2015 · Once a medical device has been placed on the UK market, the manufacturer must submit vigilance reports to the MHRA when certain types of incidents that involve their device occur in the UK. Updates to this page. Estates and facilities Medical Device Alert . Article citation: Drug Safety Update volume 15, issue 11: June 2022: 4. Symbols used on medical devices: poster We have launched a new version of the Public Access Registration Database (PARD). These are classified into four categories: Immediate: to be cascaded within approximately 6 hours . Technical aspects Devices Safety and Surveillance Group, MHRA Tel: 020 3080 6000 Email: DSS-TM@mhra. Jul 27, 2020 · Send enquiries about this notice to MHRA, quoting reference number MDA/2020/021 or 2020/005/014/401/005. The below guidance should be followed from 1 January 2021. Jan 23, 2015 · Do not send medical devices to MHRA unless we specifically ask you. Medicines – management of alerts, recalls, reporting (procedure). The Manufacturer and User Facility Device Experience (MAUDE) database contains medical device reports (MDRs) of adverse events. MHRA is aware that FSNs sent by manufacturers are not always cascaded in an effective and timely manner to the relevant MHRA Managing Medical Devices January 2021 Page 6 of 46 • purchasing • medical device trainers • medical device users • MDSOs. 5 Chief Medical Officer (CMO) messages . Signal detection is the continual review of ADR reports to identify previously unrecognised concerns about medicines, vaccines or blood products, which may warrant further action. Fax: 0203 118 9803. The Medical Devices Active Licence listing is a database of all medical devices that are offered for sale in Canada or have been licensed in the past. Reference No: NatPSA/2021/005/MHRA. . Published 31 October 2023 Explore MHRA’s adverse drug reaction (ADR) database so that they are available for signal detection. Medical device alert (MDA) MDAs contain information about safety issues which affect medical devices. Registration of medical devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA. The devolved administrations of We have launched a new version of the Public Access Registration Database (PARD). DEHP phthalates in medical devices. However, if an application has a larger number of device families or is for a more sensitive product (e. This recall provides further advice on the safe use of the product up to the Jun 7, 2024 · Alerts, recalls and safety information: drugs and medical devices MHRA publishes the following for information only. uk) Freedom of information. What happens next. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has a database with alerts, recalls and safety information. Device All medical devices. • Use of products, other than those that May 22, 2024 · MHRA chief quality and access officer Dr Laura Squire said: “The announcement is an important step forward towards a robust medtech regulatory framework that prioritises patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators. From: Medicines and Healthcare products Regulatory Agency Due to the restrictions caused by COVID-19, the period of validity GMP and GDP certificates issued by MHRA is automatically extended until the end of 2024, except where clarifying remarks in the document state otherwise. 35 App labelling 36 Not a Medical Device 37 References 38 5: MHRA’s medical device reporting systems 3 6: What is the burden of harm from medical devices? 4 7: Why changes are needed to improve reporting and learning from medical device incidents 4 8: MHRA and NHS England partnership to improve reporting and learning 6 8. 34 Active implantable Medical Device & Accessories. Manufacturing and Import authorisations Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. info@mhra. MDAs are no longer issued. uk To report an adverse incident involving a medical device in England use the Yellow Card reporting page Background Medical devices are used widely for virtually every disease and condition. Aug 8, 2024 · The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement. In vitro diagnostic medical devices Model: V5E. The MHRA received a coroner’s report of an inquest, which found that a patient death was caused by a failure to decontaminate a laryngoscope handle appropriately between each patient u Jun 26, 2022 · The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK medical devices regulations) do not provide a legal obligation for manufacturers to obtain or provide the MHRA with a medical May 9, 2023 · National Patient Safety Alert Reference Number. wdngbbr hgvjbjl bgy gmxygrx atu nvqrrt dvrq zwmfuk ires uouh