Medtech SMEs

📢 Artificial Intelligence-Enabled Device Software Functions: DECEMBER 2024 FDA released a FINAL Guidance document 💡 Per FDA this guidance was issued to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness. This guidance recommends that a PCCP describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. FDA reviews the PCCP as part of a marketing submission for an AI-enabled device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. The recommendations in this guidance apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways. The recommendations in this guidance build on FDA’s longstanding commitment to develop and apply innovative approaches to the regulation of AI-enabled devices.  #FDA #Medicaldevice #predeterminedchangecontrolplans #PCCP #AIDSFs

📢 On January 6, 2025, the FDA published the Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. 💡 As presented by FDA: this draft guidance proposes both lifecycle considerations and specific recommendations to support marketing submissions for AI-enabled medical devices. The draft guidance highlights recommendations from other guidances in order to assist manufacturers with applying those recommendations to AI-enabled devices, as well as providing additional recommendations on topics of specific relevance for AI. When final, the guidance is intended to be used in addition to other applicable guidances for a given device. Notably, this draft guidance is specific to AI-enabled medical devices. The FDA has also published draft guidance with recommendations regarding the use of AI to support development of drug and biological products. The publication of these guidances, among other actions, continues to demonstrate the agency's efforts to provide transparency and to help ensure product safety and effectiveness while supporting innovation in this rapidly growing field. 💡 Keep in mind that just a few weeks before, in December 2024, FDA published another important Guidance document in the filed: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions #FDA #SW #AI #Medicaldevice #ArtificialIntelligence

📢 BORDERLINE BETWEEN MEDICAL DEVICES AND MEDICINAL PRODUCTS under (EU) 2017/745 💡MDCG 2022-5 was revised. Not much has changed. Only section 1.2.6.1 The following example has been added to the list of examples: 💡 products specifically intended for the cleaning, disinfection or sterilisation of medical devices https://lnkd.in/dTiY6PKf #MDR #CEMARK #Borderline #CE #medicaldeviceregulation #cemarking #medicaldevice

📢 ORPHAN MEDICAL DEVICES 📢 ORPHAN INDICATIONS 💡 The term "UNMET NEEDS" exist in the MEDDEV2.7/1 rev 4 [ Section A8. Devices for unmet medical needs - aspects to consider]. This term however was not present in the MDR /IVDR or any other guidance documents. 💡 August 2022, MDCG 2022-14 [ position paper] acknowledges "ORPHAN devices" These devices, or indications, they are challenges in demonstrating sufficient pre-market clinical evidence due to the nature of an ORPHAN device or ORPHAN indication i.e small numbers of individuals each per year. 💡June 2024, a new MDCG was released: MDCG 2024-10 Clinical Evaluation of ORPHAN Medical Devices. 📢 MDR requirements to orphan devices should be balanced and proportionate in light of Article 35 of the Charter of Fundamental Rights states: “Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.” 📢 There are circumstances where it is acceptable to place an orphan device on the market with limitations in pre-market clinical data. PLEASE DO NOT HESITATE TO CNTACT OUR TEAM FOR FUTHER ASSITANCE IF YOU HAVE ANY QUESTIONS. #MDR #CER #ClinicalEvaluation #CE #CEMARK #Clinicaldata https://lnkd.in/eJTezwxn

JULY 2024 - UPDATE of the EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices Changes are mostly typos, aside from teh three below:   📢 clarification regarding legacy devices that require certification for the first time under the MDR 📢 clarification regarding legacy devices that require certification for the first time under the MDR 📢Addition of questions: Do all QMS aspects listed in Article 10(9) MDR have to be addressed? #medicaldevices #MDR #IVDR #regulatorycompliance #standards #standardisation #MedTech #HealthcareInnovation #HealthTech #PatientCare #RegulatoryFramework #MDR #IVDR #healthcare #innovation #regulatoryaffairs #regulatorycompliance #invitrodiagnostics #patientsafety

For manufacturers of hashtag #medicaldevices in the hashtag #EU. 🇪🇺 #MDCG has released a revised version of their guidance document on standardization for medical devices: MDCG 2021-5 Rev. 1. 📢 UPDATE TO INCLUDE COMMON SPECIFICATIONS [ section 3.8]  📯 (...) There, the concept “that manufacturers shall as a general rule be required to comply with the common technical specifications” has been established65. Only “for duly justified reasons” when “manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto”.   ▶ We are however still missing a significant amount of CS 😭 📢 Update on the IMDRF: In the absence of Common Specification and Harmonized standards, IMDRFs can come in handy  📯(...)These documents provide useful indications for the development of international standards in the field of medical devices and their recognition and implementation at regional and national level, which is especially important for harmonised European standards the references of which are intended to be published in the OJEU in support of MDR and IVDR. 📢The document reflects the current regulations, MDR (EU 2017/745) and IVDR (EU 2017/746), with references to previous directives removed. 📢 The role of "state-of-the-art" in standardization and conformity assessment is emphasized. 📯(...) it is not possible to impose the use of a specific standard in the conformity assessment of a product, not even on the basis of “compliance with the state of the art”: the “state of the art” expressed by standards must be taken into account but it does not mean “compliance” that must be granted with respect to the legal requirements and not to standards. 📯(...)However, “taking into consideration” is different from making any standard “mandatory”: choosing to use a standard or not, as appropriate and applicable, belongs to the manufacturer, within its overall and ultimate responsibility on the legal compliance of products intended to be placed on the EU market. 📢 New considerations are included for specific standards like EN ISO 15189 and ISO 14155:2011, as well as the MDR/IVDR standardization requests and amendments. 📢 Information on the MDCG Subgroup on Standards and the CEN-CENELEC Sector Forum on Healthcare Standards (SFHS) has been updated to reflect the current governance structure. If you need any securing compliance and the best regulatory strategy for your #Medicaldevice or in vitro diagnostics #IVDs don't hesitate to Reach out to us at info@medtechsme.com #medicaldevices #MDR #IVDR #regulatorycompliance #standards #standardisation #MedTech #HealthcareInnovation #HealthTech #PatientCare #RegulatoryFramework #MDR #IVDR #healthcare #innovation #regulatoryaffairs #regulatorycompliance #invitrodiagnostics #patientsafety

Expected Device lifetime is not to be confused with the shelf life. to demonstrate compliance to relevant GSPR you will need to define the expected device lifetime. Manufactures receive numerous nonconformities related to the fact this has not been properly defined. This can also have an impact on your Clinical development plan including study endpoints and further the PMCF activities. #MDR #PMCF #PMS #Medicaldevice #deseinginput

EXPECTED LIFETIME- It is not the same as shelf life. To demonstrate conformity with GSPR #6, you will need to define the expected lifetime. #MDR #PMCF #CEMARK #CEMARKING #Medicaldevice #PMS #Deseinginput

Artificial Intelligence (AI) and medical device software TGA clarified when AI is considered a medical device. Even if not FDA or EU, clarifications from other National Competent Authorities can always be useful insight. Don't forget that some countries do recognize market approvals from TGA ( i.e MHRA) 📢 When AI is considered a medical device  AI would generally be a medical device if it is intended to be used for:  💡 diagnosis, prevention, monitoring, prediction, prognosis, or treatment of a disease, injury, or disability  💡alleviation of, or compensation for, an injury or disability  💡investigation of the anatomy or of a physiological process  💡control or support of conception. 📢Examples of medical devices that use AI include:  💡apps that aid in diagnosing melanoma from mobile phone photos  💡analytics in the cloud that predict patient deterioration 💡chatbots that give treatment suggestions to consumers or health professionals 💡clinical decision support that uses generative AI to create symptom and diagnosis summaries 💡eye disease screening apps that cover diabetic retinopathy, glaucoma and macular degeneration 💡radiology image analysis to aid in diagnosing pneumothorax, pneumonia, tumours. You can read further information, for example, on how AI is regulated by TGA, evidence requirements for SW using AI, Synthetic data use, by clinking on this link ttps://https://lnkd.in/dJHcZP_5 #AI #medicaldevice #TGA #MDR #FDA #CEMARK

📢 UK- BREXIT and implementation of medical devices future regime. Statement of policy intent for international recognition of medical devices was updated on May 21st, 2024. 📢 MHRA currently recognise CE certification and approvals completed by the European Union (EU). 💡 This arrangement is time limited until 30 June 2030, at the latest, to support the transition following EU exit. 📢International recognition will allow MHRA to utilise the expertise and decision-making of other regulatory partners for the benefit of patients. MHRA will retain the authority to reject applications if the evidence provided is considered insufficiently robust. 💡Countries or jurisdiction (regulatory authorities): 🔖 Australia (TGA) 🔖 Canada (Health Canada) 🔖 European Union (NCA in EU & EEA) 🔖 USA (FDA) The full statement of policy intent can be found here: https://lnkd.in/d4nWf3QP #Medicaldevice #MHRA