RQM Weekly Watch #17

RQM Recap

RQM news, content recently published, and upcoming online events.

Technical Briefs

• Future-Proofing Sterilization: Understanding EPA's New EtO Standards and What To Do Now

• Three Critical Aspects of Analytical Testing for Pharmaceuticals

• Key Benefits of Chemical Characterization Laboratory Services

Video and Audio Resources

RQM is continuing our educational video series on clinical trials. Clips cover three areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. All videos in the series will be able to be viewed on LinkedIn, our podcast (Apple, Spotify), and YouTube.

Videos thus far:

1. Introducing Our Educational Video Series on Clinical Trials

2. Strategy for First-in-Human Studies (1/2)

3. Strategy for First-in-Human Studies (2/2)

4. Tactics for First-in-Human Studies

5. Strategy for Global Pivotal Studies

6. Tactics for Global Pivotal Studies

7. Would you like to get reimbursed?

8. Key Aspects of Medical Device Trial Design (1/2)

9. Key Aspects of Medical Device Trial Design (2/2)

[Upcoming] 18 July panel and Q&A – Beyond EtO: New EPA Regulations and Sterilization Alternatives, featuring Jessica Dreyer and Greg Murdock | *Register here*

[Now On Demand] On 22 May, our COO of Clinical Trials, David Novotny, joined THREAD CEO John Reites for a conversation about hybrid study approaches. | RQM website, Apple Podcasts, Spotify

Europe

• MDCG 2021-5 has been updated to revision 1. There are numerous updates (especially in terms of references) and clarifications but none that significantly affect the guidance provided in the initial version relating to EU harmonized standards and the generally acknowledged state of the art.

• Team-NB members adopted a template agreement specifying the terms of the transfer of the surveillance according to Regulation 2017/7451 for legacy devices. Team-NB-PositionPaper-TransferAgreement_v02-20240702.pdf

• MedTech Europe and COCIR were amongst the 100 industry associations that co-signed a joint statement calling for an increased budget in FP10 (EU Framework Programme (FP), establish public research, development, and innovation investments in the EU). As stated in the declaration, to further support EU Competitiveness, FP10 must focus on excellent cross-border collaborative RD&I, with strong industrial participation and a reinforced focus on competitiveness in Pilar II.  This investment is crucial to stimulate private investments in RD&I, increase public-private partnerships in RD&I activities, and foster European competitiveness as well as help the EU keep pace with global technological developments.

• Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC. Enters into force on 18 July 2024.

• In France ANSM updated their guidance for reporting stock shortages of a medical device or essential in vitro diagnostic medical device that affect France., including updated templates to download

• A reminder that the swissdamed Actors module goes live from 6th August 2024.

• Swissmedic announced an 80% reduction in the flat-rate fees for authorization procedures is available for certain academic clinical trials: Academic trials: Application for fee reduction for clinical trials with medical devices (clinical investigations and performance studies).

• The HPRA have updated their Guide to Fees for Human Products to version 43, but there are no apparent changes to fees for medical devices or IVDs.

• The MHRA updated their guidance on clinical investigations with the following amendments: Updates to clarify the fees and payment process, addition of guidance on early terminations and temporary halts in GB and NI and clarification that Annex XVI applications cannot be accepted in GB.

• Also in the UK, DEKRA have updated their scope for UK Approved Body activities.

United States and Canada

• FDA's CDRH announced the expansion of the Total Product Life Cycle (TPLC) Advisory Program (TAP). To date, the TAP Pilot has enrolled 46 Breakthrough Designated Devices in the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5). The expansion of TAP will cover innovators and devices in new clinical areas as follows: the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A) (both 1st October 2024), and the Office of Orthopedic Devices (OHT6) (1st January 2025).

Rest of World

• Nothing of note this week.

Recalls, FSCAs, and Alerts

Class I Recall (US)

• None to report this week.

FDA Safety Communications

• None to report this week.

Other FSCAs / Safety Notices

• FSNs published in the UK: 

In the News

• FDA continues crackdown on plastic syringes made in China

• Philips Disputes Additional Deaths Linked To May Recall Of Breathing Machines (MedTech Insight)

Warning Letters (US)

Approvals and Clearances

• None to report this week.

Articles We Read

Note: We've decided to begin including articles behind a paywall (MedTech Insight) and will clearly note where that's the case. We recognize some readers subscribe to MedTech Insight.

Europe Related

• EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise (MedTech Insight)

• MDCG 2021-5 Rev. 1: EU’s Standardization Guidance Brought Up To Date (MedTech Insight)

• EU’s Historic PFAS Restriction Looms Over Medical Devices Sector (MedTech Insight)

• Does The AI Act Apply To My Medtech Product And What Do I Need To Know? (MedTech Insight)

• End for telemedicine software providers

United States Related

• Unpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials (Health Law Advisor Blog)

• FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot (MedTech Insight)

• FDA Offers Draft Guidance For Developers Of Drug Delivery Devices (MedTech Insight)

• Experts: Chevron deference ruling could impact recent FDA regulations (RAPS)

• FDA drafts guidance on essential outputs for drug delivery devices (RAPS)

General Industry News

• IMDRF publishes AI/ML guiding principles echoing US, UK, Canadian regulators (RAPS)

Stay In the Know

• Subscribe to the RQM Device Advice podcast (Apple, Spotify)

• Visit the RQM Knowledge Center for upcoming and on-demand content

• Subscribe to the RQM YouTube channel

• Follow RQM on LinkedIn for regular updates