In May 2024, major regulatory updates were announced across the UK, EU and Switzerland to enhance medical and in vitro diagnostic devices. The COMBINE project was launched to streamline regulations, and new standards and frameworks were proposed to improve safety, compliance, and timely access to innovative treatments.
The European Commission has launched the COMBINE project to streamline regulatory processes for combined studies involving medicinal products, medical devices, and in vitro diagnostics. This initiative aims to address current regulatory challenges, reduce administrative burdens, and make Europe more attractive for research investments. The project's ultimate goal is to provide patients with faster access to innovative and personalized treatments. The next steps involve developing proposed solutions to improve the regulatory landscape, with collaboration from national authorities, ethics committees, and the European Medicines Agency.
The MDCG 2024-6, 7, 8, and 9 documents provide comprehensive templates for the preliminary assessment and re-assessment of Notified Bodies (NB) for designation under the MDR and IVDR. These documents outline the necessary documentation and processes, covering organizational and general requirements, quality management, resource requirements, and process requirements. They emphasize the importance of independence, impartiality, confidentiality, and competence of personnel. The documents stress thorough evaluation procedures, continuous monitoring, and regulatory compliance to ensure the integrity and reliability of conformity assessments conducted by NBs.
Swissmedic has adopted MDCG 2024-4 and the related appendix for the reporting of serious adverse events and device deficiencies during category C interventional performance studies for in vitro diagnostics(IVDs).
The term "clinical trial" in Switzerland includes "clinical investigation" for medical devices under MedDO and "performance study" for in vitro diagnostics under IvDO. The Human Research Act (HRA) and the Ordinance on Clinical Trials with Medical Devices(ClinO-MD) regulate these trials, aligning with EU MDR and IVDR regulations. ClinO-MD specifies requirements for clinical trials involving medical devices and in vitro diagnostic devices, ensuring compliance with Swiss and EU standards.
The general information sheets for clinical investigations with medical devices or Performance studies with IVD have been updated and are available at the following links:
- IVDs
The MHRA has initiated a four-week consultation to enhance the safety of high-risk in vitro diagnostic (IVD) devices. This policy proposes additional requirements for high-risk IVDs, such as those identifying blood types and life-threatening diseases. The consultation also considers removing the Coronavirus Test Device Approval process to streamline regulatory compliance. The feedback gathered will guide revisions to IVD common specifications within a draft Statutory Instrument as part of the future core medical device regulations to be published later in 2024. The updated regulations will then come into force in 2025.
The MHRA has announced a proposed framework for the international recognition of medical devices. This framework aims to recognize regulatory approvals from Australia, Canada, the EU, and the USA based on device type, class, and prior approval, with potential inclusion of Japan. This initiative seeks to reduce duplicate assessments, ensuring safe access to quality-assured medical devices while allowing resources to focus on innovative products. The framework remains in draft form, and final regulations are anticipated as part of core medical device regulations to be published later in 2024, coming into force in 2025.
The MHRA wrote a draft policy for recognition by the UK of international regulators’ approvals of medical devices available at the following link:
This draft policy describesthe eligibility criteria, access routes, additional requirements (e.g., UKRP, UDI,PMS activities) and exclusions.
The MDCG 2022-4 Rev. 2 document provides guidance on appropriate surveillance for medical devices under the transitional provisions of Article 120 of the MDR. The main changes from the previous version include alignment with Regulation (EU) 2023/607, which amends the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
Key updates are related to:
- Transitional period extensions
- Adjustments for regulatory alignment with Regulation (EU) 2023/607
- Surveillance requirements for legacy devices under MDD/AIMDD with the consideration of certain MDR requirements (i.e., PMS, vigilance, economic operator and device registration)
- Quality management system to comply with MDR
- Notified Body agreements with manufacturer
- Adjustment of audit program by NBs due to change of transitional provisions
- Reporting of necessary documentation (e.g. PSUR as part of NB surveillance process)
On May 27, 2024, the Council of the European Union adopted new regulations to improve the safety, quality, and accessibility of substances of human origin (SoHO). These regulations aim to harmonize standards across the EU, ensuring high safety and quality for blood, tissues, and cells used in medical treatments. They extend protective measures to additional groups, including donors and offspring from medically assisted reproduction,and support innovation by creating conditions for safe, effective, and accessible therapies. These new rules could impact the Medical Devices Regulation (MDR) and could necessitate updates to MDR compliance processes for devices involving SoHO.
After the adoption in April of the European Parliament, the Council of the European Union adopted the new measures to enhance the availability of in vitro diagnostic (IVDs) devices for patients and healthcare providers.
These measures, proposed in January 2024, aim to ease the transition to the new EU rules on IVDs by allowing additional time based onthe device's risk level. For instance, high-risk devices like HIV tests have until December 2027, moderate-risk devices like cancer tests have until December 2028, while lower-risk devices like pregnancy tests have until December 2029.
In addition, the measures introduce a mandate for manufacturers to notify national authorities and the healthcare sector (e.g.,distributors, healthcare professionals) in advance if they anticipate any supply disruptions. This is intended to mitigate risks of shortages and ensure continuity in patient care.
Finally, the gradual implementation of the EUDAMED is expected to take effect as of late 2025 and will enhance transparency and provide a comprehensive view of medical devices available in the EU market.
The regulation will enter into force following publication in the EU’s Official Journal.
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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.