Our August 2023 MedTech news roundup covers upcoming legislative changes for Post-Market Surveillance in the UK, updates from the EU Commission and Team NB on the MDR transitional provisions, the latest on the Swiss Data Protection Act, and guidance from the FDA on Off-The-Shelf software, and clinical studies for devices that treat Opioid Use Disorder. For this and more, read on…
PMS requirements for UK set to change
On 26 July, the World Trade Organization (WTO) published a notification of the intended legislative changes related to Post-Market Surveillance (PMS) for medical devices in Great Britain.
The measures will amend the MDR 2002 as applicable in Great Britain, and aim to introduce clearer, risk proportionate PMS requirements with improved regulatory oversight. Many of the proposed PMS provisions are aligned with the EU MDR. The key changes include:
- An increased scope of devices that must comply with the new PMS requirements, including CE marked devices
- Detail regarding what must be included as part of a PMS system, including PMS data collection methods, to support improved data capture and harmonization across manufacturers
- A reduction in the timescale for reporting serious incidents from 30 days to 15 days to support faster detection of safety issues
- More stringent timeframes for PMS data periodic reviews to support earlier detection of trends / signals that may have an impact on the safety of a medical device
- Improved coordination and collaboration between manufacturers, UK Approved Bodies, and the MHRA to support regulatory oversight
Find out more about the legislative changes here.
EU Commission issues updated Q&A on MDR & IVDR amending regulation
In our April MedTech news roundup, we shared the EU Commission´s Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
This July, the Commission updated the Q&A to expand on certain answers. You can find the updated document here.
Team NB shares position on new MDR transition timelines
Team NB (The European Association of Medical Devices Notified Bodies) has released a position paper on the new MDR transition timelines and notified body capacity.
The whitepaper discusses why the new MDR transitional periods were necessary and the consequences that notified bodies expect from this change. It also elaborates on the current status quo of notified body capacity and measures that will help to secure a successful transition.
You can read the full position paper here.
Revised Swiss Data Protection Act to come into force this September
This month the revision of the Swiss Data Protection Act (DSG) has been completed. The new rules of the DSG and the implementation provisions in the new Data Protection Ordinance (DSV) and the new Ordinance on Data Protection Certifications (VDSZ) will come into force on 1 September this year, with no transitional periods.
To ensure compliance with the newly applicable data protection regulations, Swiss companies are being urged to urgently make the necessary adjustments to their data protection setups, in particular to their data protection declarations and contracts.
This article from Economie Suisse outlines some useful questions and answers regarding the new law.
FDA publishes final guidance on Off-The-Shelf software in medical devices
Earlier this month the FDA issued updated guidance on Off-The-Shelf software in medical devices. The document, which supersedes a previous version issued in 2019, aims to provide guidance to medical device manufacturers on the appropriate use and documentation of OTS software in their devices.
The guidance provides information regarding the recommended documentation to be included in a premarket submission for OTS software and describes information that would typically be generated and documented during software development, verification, and validation.
You can access the guidance here, and for a useful overview of the guidance see our recent article here.
FDA shares draft guidance on clinical studies for devices that treat OUD
The FDA has shared draft guidance that provides recommendations for the design and development of pivotal clinical studies for devices intended to treat Opioid Use Disorder (OUD). This comes as part of the FDA´s strategy for tackling the opioid overdose crisis in the US, which includes steps to decrease unnecessary exposure to opioids, prevent new cases of OUD, and support the treatment of people with the disorder.
You can read the draft guidance here.
Japan´s PMDA issues guidance on informed consent in clinical trials via electronic means
Japan´s PMDA has issued guidance on consideration points regarding informed consent using electromagnetic means in clinical trials and post-marketing clinical trials.
The guidance summarises the points to consider when providing subjects with explanations of trial-related information via remote methods using, for example, PCs, tablets, telecommunication lines, videos, and real-time video calls.
You can read the guidance here.
That concludes our August 2023 MedTech news roundup. Check back in September for more medical device news and updates.
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