Our MedTech news roundup for August 2024 includes the latest from Swissmedic on EU IVDR equivalence and Swissdamed respectively, and a new EU Commission survey on eIFU. Guidance updates from the UK’s MHRA also feature, along with news from the FDA on eMDR system enhancements, MDR adverse event codes, electronic submissions for De Novo requests, and draft guidance on PCCPs. And don’t miss this month’s announcements from China’s NMPA regarding its medical devices Urgent Use Policy and new device classification rules. Read on for more…
MedTech news from Switzerland & Europe
Swissmedic ensures equivalence with EU IVDR transition provisions
In the EU, Regulation (EU) 2024/1860 amending the EU-IVDR regarding the transitional provisions for certain IVD medical devices was adopted on 13 June 2024. The measures implemented as part of this amendment included the extension of the validity of certain certificates issued under the old legislation until 2027 – 2029 depending on device classification.
As reported by Swissmedic, on 14 August the Federal Council stated that these amendments must also be implemented in Switzerland to avoid any potential supply bottlenecks.
Additionally, the product registration obligation already set out in the MedDO and IvDO will enter into force in 2026, with the amendment of the MedDO and IvDO planned for autumn this year.
Actors module in Swissdamed goes live
The first module of the Swissdamed medical devices database is now live. The Actors module, which enables economic operators to register online, was introduced on 6 August.
The second module “Devices”, which will facilitate the voluntary registration of certain medical devices, will go live in several phases, with the first release planned for 2025. Find out more about Swissdamed here.
EU Commission launches eIFU survey for healthcare professionals
The EU Commission has launched a new survey to gather insights from healthcare professionals regarding electronic instructions for use (eIFU) of medical devices.
The survey, which is open until 11 October this year, seeks feedback on the potential scope expansion of eIFU Implementing Regulation (EU) 2021/2226 to include all professional-use medical devices. Available in all EU languages, the five minute survey also aims to collect opinions on eIFU for non-professional use devices.
Find out more about the survey here.
Medical device updates from the UK
MHRA updates guidance on clinical investigation notification for medical devices
This month the UK’s MHRA made two updates to its guidance on notifications about clinical investigations for medical devices. A section on regulatory advice meetings, and a new QSR template have been added. See more on the updates here.
MHRA updates guidelines on how to register medical devices
The MHRA has updated its guidelines on how to register medical devices intended for the Great Britain and Northern Ireland markets. The reference guides for Account Management and Device Registration have been updated to reflect changes to the registration system. Find out more here.
MedTech news & guidance from the US
FDA commits to regular enhancements of eMDR system
The FDA will regularly implement enhancements to CDRH’s Electronic Medical Device Reporting (eMDR) system to provide early notice and predictability about eMDR system changes – especially for manufacturers submitting HL7 ICSR XML reports using AS2.
Via a regular schedule, the FDA expects to take the following steps for every cycle of new enhancements:
- June | Upcoming enhancements announced
- August | Implementation Package released
- September | Enhancements to pre-production (ESG Test) deployed
- March | High-impact enhancements to production deployed (7 months after the Implementation Package is released)
The upcoming 2024 enhancements to eMDR include the following:
- Require weight unit if weight is provided
- Require all Adverse Event codes in initial MDRs
- IMDRF 2024 maintenance updates
FDA updates MDR adverse event codes
The FDA has updated its comprehensive set of resources for reporters to use when selecting event codes in a Medical Device Report (MDR). The resource page contains information about the codes and the MedWatch Medical Device Reporting Code Instructions, sometimes referred to as the coding manual. On 12 August, the 2024 maintenance update list was shared, containing summaries of updates to the FDA MDR adverse event codes. Read more about the updates here.
Electronic submission guidance for De Novo requests published
The FDA has published final guidance that provides the standards for the electronic submission of De Novo Requests, a timetable for standard establishment, and exemption criteria.
The guidance also represents part of the FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools to improve submission consistency and review process efficiency.
FDA will require De Novo Request electronic submissions to be provided as described in the guidance from 1 October 2025.
You can access the final guidance here.
FDA updates information on MDR data files
The FDA has updated its MDR data files to provide the medical device reports of suspected device-associated deaths, serious injuries, and malfunctions received from 1984 – 1996 through CDRH’s legacy Device Experience Network (DEN) reporting system, and reports received under the Alternative Summary Reporting Program from 1999 – April 2019. Read more on this here.
Draft guidance shared on PCCPs for medical devices
The FDA has issued draft guidance to propose a policy for Predetermined Change Control Plans (PCCPs) and provide recommendations on the information to include in a PCCP in a medical device marketing submission.
The draft guidance document recommends that a PCCP for a device describes:
- The planned device modifications
- The associated methodology to develop, validate, and implement those modifications
- An assessment of the impact of those modifications
The recommendations apply to devices (including device-led combination products), reviewed through the 510(k), De Novo, and PMA pathways. Find out more here.
Final guidance issued on acceptable media for electronic product user manuals
The FDA has issued final guidance that allows manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. The guidance marks the FDA’s recognition of the wide use of electronic media for instruction provision, and capitalises on the opportunity to reduce paper consumption, increase accessibility, and provide rapid means for editing and updating content. Access the final guidance here.
Medical device regulatory announcements from China
Medical devices Urgent Use Policy to be applied nationwide
The “Regulation on the Management of the Importation of Drugs and Medical Devices from Hong Kong and Macao into the Nine Mainland Cities of Greater Bay Area” takes effect on 1 December this year.
The availability of Real-World Study (RWS) in GBA marks a key change in the document, as previously, RWS was only permitted for use in Hainan. Article 23 in the new regulation states that designated medical institutions in GBA are encouraged to collaborate with manufacturers to conduct real-world studies – the data from which can support device registration and marketing in mainland China.
Find out more about the new policies here.
NMPA’s new device classification rules to take effect in September
In May this year, the NMPA published the “Announcement on Standardizing the Classification of Medical Devices” that revised the classification processes for devices, combination products, and newly developed medical devices, and standardised the classification materials. NMPA will implement these new rules from 1 September this year. Find out more here.
That concludes our August 2024 MedTech news roundup. Check back in September for more medical device news and updates.
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