May Medical Device Regulatory Updates

21st May 2024: MHRA Issues Policy on International Medical Device Recognition

• The MHRA now recognizes regulatory decisions from Australia, Canada, the EU, and the USA to streamline approvals.
• Aims to enhance patient safety while making the UK a more attractive market for innovators.
• The framework would reduce duplicate assessments, speeding up access to new devices.
• A certificate of international recognition would allow access to the GB market but not provide UKCA marking.
• The MHRA is considering adding Japan and Singapore as comparable regulatory countries.

13th May 2024: Glasgow University Study on Sensory Device for Heart Failure

• Sensinel, a wearable device from Analog Devices, monitors cardiopulmonary measurements remotely.
• Detects fluid accumulation, a key factor in heart failure, allowing early intervention.
• Could reduce emergency hospital admissions by enabling treatment in the community.

9th May 2024: MHRA Launches AI Airlock Project

• Addresses regulatory challenges of AI in medical devices.
• Focuses on balancing innovation with patient safety.
• Five key principles for AI regulation: safety, transparency, fairness, accountability, and contestability.
• A webinar on 23rd July 2024 will provide further details.

23rd May 2024: FDA Expands Recall of Chinese-Made Syringes

• Additional Chinese syringe manufacturers added to the recall list due to leakage, breakage, and dosage errors.
• FDA recommends avoiding Chinese-made syringes if possible and closely monitoring those in use.
• Part of broader U.S. trade measures increasing tariffs on Chinese medical goods.

20th May 2024: FDA Approved as WHO Listed Authority

• The FDA joins the WHO Listed Authorities, confirming its regulatory standards meet the highest global benchmarks.
• The European Medicines Regulatory Network (EMRN) and Singapore’s Health Sciences Authority also received WHO approval.

21st May 2024: Study on Robotic Deep Brain Stimulation (DBS) Device

• AiM Medical Robotics, in collaboration with Harvard and Brigham and Women’s Hospital, is testing a robotic DBS system.
• Designed for conditions such as Parkinson’s, epilepsy, and brain cancer.
• The system demonstrated precise placement of brain stimulation leads in a cadaver trial.
• Expected to reduce surgical time by 50% and lower healthcare costs.

13th May 2024: FDA Approves 882 AI/ML-Enabled Medical Devices

• From August 2023 to March 2024, 151 new AI-enabled devices were added.
• Includes image analysis software, surgical tracking tools, and cardiac monitoring systems.
• The FDA will continue updating its list periodically.

24th May 2024: MedTech Forum Highlights Climate Change Risks

• WHO and the European Commission warn that rising temperatures could impact health and medical supply chains.
• The 2022 heatwaves led to 60,000–70,000 preventable deaths in Europe.
• The industry is urged to develop sustainable and resilient medical technologies.

21st May 2024: European Council Approves AI Act

• The first comprehensive AI regulation covering all 27 EU countries.
• Applies to companies using EU customer data.
• Establishes new regulatory bodies, including an AI Office and an advisory panel.

20th May 2024: EMRN Approved as WHO Listed Authority

• The European Medicines Regulatory Network (EMRN) was added to the WHO Listed Authorities.
• Recognized for meeting high standards in regulatory practices.

16th May 2024: Lithuanian Smart Wristband Receives CE MDR Certification

• The TeltoHeart wristband detects atrial fibrillation with continuous heart rate monitoring.
• Features a high-precision 6-lead ECG.
• Marketed as a breakthrough in wearable diagnostics.

21st May 2024: EMA Issues Guidance on Combination Devices

• Covers lifecycle management, packaging, companion diagnostics, and medical substances.
• Supports compliance with EU MDR and IVDR regulations.

MDCG Releases New Guidance on Notified Body Assessments

• Updated templates for assessing Notified Bodies under MDR and IVDR.