Recent global regulatory updates include changes for software-based medical devices, prescription lenses, and microbial, recombinant, or animal substances. Effective June 15 and July 1, 2024, with reclassification by July 1, 2026. High-risk devices have limited audits; spectacle lenses are ARTG exempt from June 15.
The UK’s policy on the international recognition of medical devices aimsto simplify market access in Great Britain by leveraging approvals from recognized regulatory authorities such as those in Australia, Canada, the EU,and the USA.
To be eligible for the recognition program, the product needs to
· comply with the relevant legislation(s)of the recognized country(ies)
· have English language labelling and packaging
· comply with specific applicable Great Britain requirements for electronics compatibility (frequency, voltageand plug type), units of measurement, and labelling materials of concern where applicable (for example, for substances which are carcinogenic, mutagenic ortoxic to reproduction (CMR), of category 1A or 1B, or could result insensitisation or an allergic reaction)
· have all aspects of the device,including the design, manufacturing process and intended purpose, be in line with the device authorized by the recognized country(ies)
· have a UK responsible person with the name and address of which will be included on the label
· have a physical unique device identifier (UDI) on parts and labels in compliance with the requirements in the UK Medical Devices Regulations or the the recognized country(ies)
· comply with the new post-market surveillance (PMS) requirements in the UK Medical Devices Regulations which are expected to come into force in 2024
Devices authorized in other recognized jurisdictions and class I/Aself-certified in UK, will need to have a manufacturer’s declaration for an appropriate QMS such as ISO 13485 or product-specific equivalent.
Overall, manufacturers need to submit a dossier in the International Medical Device Regulators Forum (IMDRF) ‘table of contents’ format, or equivalent format used in the recognized country(ies) that will not be reviewed during the submission process but in case of post-market events. At the submission, evidence of approval(s), PMS plan/PMS report/PSUR, SSCP, implant cards, patient information leaflet, will be reviewed as applicable and as required. For devices with abridged assessment (e.g., De Novo in US) ordevice-specific requirements (e.g., devices legislation in Canada) in the recognized country(ies):
- device classification will be confirmed,
- clinical data will be reviewed on a sampling basis,
- and premarket (training and test) data, implementation verification & validation as well as use of predetermined change control plans, will be reviewed for AIaMD.
Some products are excluded from this recognition program such as (but not limited to) custom-made devices, SaMD authorized via an equivalence to apredicate device in US or that do not satisfy to the intended purpose guidelines, class III or class IIb implantable devices relying on equivalence to a predicate device in US, products excluded from the scope of UK MDR 2002 listed in Regulation 3.
The proposed framework is a draft and the final version would come into force at the same time as the future core regulations which are aiming to be in force in 2025.
HPRA, the Irish competent authority, published the Medical Devices Newsletter, Issue 58 and emphasizes important updates in June for medical device manufacturer, with the following key elements:
- 2024 regulatory milestones: HPRA reminds the critical milestones in 2024 for legacy devices transitioning under MDR or IVDR. The next milestone being September 26,2024 to have a written agreement in place with a notified body.
- EU regulatory updates: It includes updates on recent proposals and changes in EU to improve the availability of in-vitro diagnostics and medical devices, and the sequential implementation of EUDAMED. It is expected that the first five completed modules (Actor, Devices, NB & Certificates, Market Surveillance and Vigilance) will become mandatory during Q1-2026.
- HPRA focus for 2024: The newsletter details HPRA's strategic priorities and focus areas for the year, including enhancing regulatory processes and ensuring compliancewith new regulations.
- Updates for health institutions: HPRA reminds the requirements applicable on May 26,2024 and detail the actions required by health institutions including review ofcompliance with IVDR Article 5(5) and Annex I, ensuring documentation outlined in Article 5(5) is available, definition of documented plan for reaching compliance (e.g. timelines, progress to date)
- Economic operator (EO) registration obligations: EOs are reminded that registration details, on both the HPRA’s national registration database and on Eudamed, should be kept up to date.
- Distributor and importer inspections: The newsletter outlines the inspection plan in Ireland conducted between February and May 2024. Though HPRA will describe the major non-compliances, the key observation is that ISO 9001 certification or similar should be aware that this does not in itself imply compliance with EU medical device regulatory requirements.
- Clinical investigations update: This section provides updates on clinical investigations, including new guidelines and requirements for conducting clinical trials with medical devices (MDCG2024-3, MDCG2024-5).
- Published documents: The newsletter lists all EU publications issued from January 2024and relevant to medical device stakeholders.
The Therapeutic Goods Administration (TGA) has introduced new measures to enhance the safety review process for the highest-risk implantable and cardiac invasive medical devices used in first-in-human clinical trials. These changes stem from the 2019 Action Plan for Medical Devices and consultations on proposed regulatory changes.
Key updates effective from April 5, 2024, include:
CTN Form Enhancements:
Legislative Changes:
Impact on Trials:
Sponsor Interaction:
These measures aim to ensure the highest safety standards for participants in clinical trials involving high-risk medical devices.
The Swiss Federal Council approved the amendments to the ordinance srelating to the Human Research Act (HRA), adopted them on 7 June 2024 and made them effective from November 1, 2024. Significant updates are introduced for medical devices (MD) and in vitro diagnostic (IVD) devices to enhance participant protection, improve regulatory efficiency, and align with international standards. The key updates for MDs and IVDs are:
Electronic Consent (E-Consent):
- Researchers can now obtain consent from participants electronically. This change is reflected in the Clinical Trials Ordinance for Medical Devices (ClinO-MD) and the Human Research Ordinance (HRO). This digital approach facilitates easier and more efficient consent processes.
Data Anonymization and Coding:
- The regulations update standards for anonymizing and coding health-related personal data and biological materials. This ensures enhanced data protection and risk assessment, aligning with current technological advancements in data processing(ClinO-MD, HRO).
Transparency Requirements:
- New transparency rules require researchers to publish summaries of clinical trial results in relevant national languages. These summaries must be made publicly available, ensuring that trial outcomes are accessible and understandable to a broader audience. Full compliance with these transparency requirements is mandated by March 1, 2025.
Extended Data Retention:
- Clinical trial data for medical devices must now be retained for 20 years. This extension aims to improve long-term data availability, aiding future research and regulatory reviews.
Improved Information for Participants:
- Researchers must provide clear, comprehensive information to participants, emphasizing the possibility of incidental findings. This requirement ensures participants are well-informed about the study's potential outcomes and their rights (ClinO-MD,HRO). This includes prenatal or pre-symptomatic genetic tests or genetic tests for family planning as well as the communication of individual results.
Alignment with EU Regulations:
- The amendments bring Swiss regulations in line with EU Regulation No. 536/2014,streamlining processes for transnational research projects. This includes harmonizing notification, reporting, and deadline requirements for clinical trials involving medical devices.
Transitional Provisions:
- Ongoing research projects approved under existing laws will transition to the new requirements, with specific timelines for full compliance. Researchers are granted a transition period until October 31, 2025, to adapt to the new regulations for documentation and reporting.
The Medical Device Coordination Group (MDCG) guidance document MDCG 2024-1-5 provides detailed guidance on the vigilance system for CE-marked urogynaecological surgical mesh implants used in the treatment of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
The MDCG guidance document reminds the general reporting requirements applicable to allmedical devices, but does not provide real additional or unique obligations for urogynaecological surgical mesh implants within the scope of this guidance.This includes:
- Reporting of serious incidents
Manufacturers must report serious incidents to the relevant Competent Authority (CA) asdefined in Article 2(65) of the MDR. This includes incidents where the manufacturer is uncertain about the reportability or needs time to clarify the root cause (Article 87(6),(7) of the MDR). The reporting should adhere to the timelines specified in Article 87(2) to (5) of the MDR, ensuring prompt communication of potential risks.
- Periodic summary reporting
For similar serious incidents involving the same device or device type, manufacturers mayuse Periodic Summary Reports (PSR). This alternative reporting method allows consolidated reporting, provided the root cause is identified or corrective actions are implemented. The format, content, and frequency of PSRs must be agreed upon with the Coordinating Competent Authority, in consultation with other relevant authorities.
Until EUDAMED becomes fully functional, CA, economic operators and other relevant parties should follow MDCG 2021-1 Rev. 1 “Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional” and communicate the PSR at the national vigilance system level.
- Trend reporting
Manufacturers are required to report any statistically significant increase in the frequency or severity of non-serious incidents or expected undesirable side effects. Such trends must be reported when they can indicate a change in the risk-benefit profile of the device, potentially impacting patient safety.
The primary advantages of utilizing this guidance are evident in the provided examples ofdevice-related issues that led to incidents or serious incidents, and the associated reporting requirements linked to IMDRF Terminologies for Categorized Adverse Event Reporting (AER) codes. These examples are organized into categories for reporting individual serious incidents, through Periodic Summary Reporting (PSR), or when a trend is identified.
In 2021, Health Canada, the FDA, and the UK's MHRA established 10 guiding principles for good machine learning practice (GMLP) to ensure the development of safe, effective, and high-quality AI/machine learning technologies for medical devices. Building on these principles, they have now introduced guidelines for transparency in machine learning-enabled medical devices (MLMDs). Transparency involves clear communication of a device's intended use, development, performance, and logic to relevant audiences, which include healthcare professionals, patients, and regulatory bodies. Effective transparency helps in managing risks, understanding device functionality, and fostering trust. It also includes human-centred design principles to enhance user experience and involves providing detailed information throughout the device's lifecycle. The guidelines cover aspects like the relevant audiences, motivation, type of information to share, placement, timing, and methods to support transparency, aiming to ensure safe and informed use of MLMDs.
A medical device manufacturer must demonstrate compliance with the Essential Principles by identifying applicable safety and performance requirements, documenting rationales for non-relevant requirements, and summarizing supporting evidence.
SCHEER provided an update of the guidelines on the benefit-risk assessment of phthalates in certain medical devices. The guidelines cover phthalates which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED). The guidelines describe the methodology for performing a benefit-risk assessment justifying the presence of CMR 1A or 1B and/or ED phthalates in medical devices and/or parts or materials used there in at percentages above 0.1% by weight(w/w).
The guidelines further support manufacturers with methodologies to justify the use of CMR/ED substances above the quantitative limit regarding the available alternatives and the analysis of potential patient exposure. They also describe the methodology for the evaluation of possible alternatives as replacement of CMR/ED phthalates currently used in medical devices, including alternative materials, designs or medical treatments.
The benefit-risk assessment needs to be included into the relevant documents of the technical documentation to meet the GSPR 10.4 such as the biological evaluation report, clinical evaluation report or risk management file.
The revision 1 of MDCG 2022-13 document provides updated guidance on the designation, re-assessment, and notification of conformity assessment bodies (CABs) and notified bodies (NBs) under the MDR and IVDR regulations. The document has been updated to include additional guidance on the conduct of joint assessments relating to the scope extension of designations and provide further details of procedures for the designation and re-assessment of NBs.
The EU's Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) seeks external experts for a working group assessing health risks associated with non-medical brain stimulators. Experts in brainstimulation by electric, magnetic, or electromagnetic fields, neuroethics, and neurology are invited to apply. Applications must be submitted online by August 31, 2024. Selected experts will participate in meetings and contribute to drafting the scientific opinion. Proficiency in English and submission of relevant documentation are required.
Changes to the regulation of software-based medical devices, prescription spectacle lenses, and medical devices containing microbial, recombinant, or animal substances, as well as application audit requirements, came into effect on 15 June 2024 for software-based medical devices and prescription spectacle lenses, and will take effect on 1 July 2024 for devices containing microbial, recombinant, or animal substances and application audit requirements. Notably, classification rule 5.5 was amended to exclude devices containing microbial or recombinant substances and to specify requirements for animal-origin substances. Sponsors must reclassify affected devices by 1 July 2026. Software-based medical devices transitioning to higher risk classifications have an alternate pathway for compliance, while mandatory application audits are now limited to high-risk devices, including Class III devices with MDSAP and US FDA 510(k) approval. Prescription spectacle lenses are exempt from ARTG inclusion from 15 June 2024.
The MDCG2024-10 provides detailed guidance on the clinical evaluation of orphan medical devices, which are designed for rare diseases affecting fewer than 12,000 individuals annually in the EU. The devices also need to meet one of the following criteria:
- There is insufficiency of available alternative options for the treatment, diagnosis, or prevention of this disease/condition,or
- The device will offer an option that will provide an expected clinical benefit compared to available alternatives or state of theart for the treatment, diagnosis, or prevention of this disease/condition, taking into account both device and patient population specific factors.
These devices face unique challenges due to the small patient populations and the ethical and practical difficulties in conducting large-scale clinical trials. The guidance is aimed at providing recommendations and tolerances to ensure that these devices meet the clinical evaluation requirements and applicable GSPRs.
The document is divided into two main parts: Clinical Evaluation Considerations and Procedural Considerations. The first part addresses the challenges in generating pre-market clinical data and the role of non-clinical data. It emphasizes that while orphan devices must comply with the GSPR, there may be acceptable limitations in pre-market clinical data if justified. This includes ensuring that the benefit-risk ratio is acceptable and that any remaining limitations are addressed through a well-structured PMCF plan. The guidance also emphasizes the importance of non-clinical data, such as results from laboratory tests and computer models, which can support clinical evidence when direct clinical data is limited.
The second part, Procedural Considerations, provides guidance for notified bodies on assessing orphan devices. It outlines the responsibilitiesof notified bodies, including early verification of orphan status and the assessment of technical documentation. The role of expert panels is also highlighted, where they may provide advice on orphan device status and required clinical data. This consultation can help ensure that the clinical evaluationis appropriate and that any limitations in pre-market data are adequately addressed. Manufacturers of orphan devices are recommended to consult the expert panel with a detailed clinical development plan and a comprehensive justification that the device meets the status of orphan device.
The guidance document also includes appendices that offer additional guidance on creating clinical evaluation reports, considerations for clinical investigations, and the extrapolation of clinical data to orphan indications.
Overall, MDCG 2024-10 aims to balance the need for rigorous clinical evaluation with the practical realities of developing orphan devices This approach helps facilitate the development and availability of orphan devices,ultimately benefiting patients with rare conditions who often have limited treatment options.
Health Canada is proposing amendments to the Food and Drug Regulations and the Medical Devices Regulations to address and mitigate health product shortages. The consultation, open from June 25 to July 25, 2024, seeks feedback on these amendments aimed at preventing shortages of drugs and medical devices for human use and reducing their impacts when unavoidable. The government invites input from provincial and territorial governments, manufacturers, distributors, importers, healthcare partners, and the public. The proposed changes and planned actions over the next four years focus on enhancing systems for readiness and rapid response, early detection of shortage risks, and timely restoration of product access.
Swissmedic announced the Go-Live of Swissdamed Actors module and detailed from August 6, 2024. By this date, economic operators must register through the swissdamed system.
Applications for registration and for changing the CHRN, as well as notifications for mandates, will continue to be accepted as PDF forms until 26July 2024 (submission date). After that date, these forms will no longer be considered and an online contact form will need to be completed. Registered operators will have their data migrated and will only need to check it after being informed by letter beginning of August.
The device registration is planned to be voluntary in 2025 and a device registration testing began in June 2024, with a group of manufacturers that issued UDIs.
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