Our January MedTech news covers a broad range of recent guidance and updates from the EU, Switzerland, the US & Canada, the UK, and China. Read on for news related to MDR exemptions, MDR Annex XVI products, clinical investigations, and the designation of EU reference labs for high-risk IVD medical devices. You’ll also find updates on the FDA’s eSTAR program, guidance related to premarket submissions, and the latest on FDA’s new Digital Health Advisory Committee. And finally, don’t miss the UK’s MHRA update on its proposed regulatory reform.
For all this and more, see below…
Guidance and updates from the EU & Switzerland
Manufacturers and notified bodies urged to ensure timely compliance with MDR & IVDR
The MDCG has revised its position paper – MDCG 2022-11 Rev. 1 to include a call to manufacturers to transition to the Regulations and submit their applications for certification without delay. Furthermore, the revised paper calls on notified bodies to “streamline the certification process”. Access the full paper here.
MDCG shares guidance on exemptions from MDR requirement to perform clinical investigations
The MDCG has released guidance that clarifies the exemptions from the requirement to perform clinical investigations according to Article 61(4)-(6) MDR, and the associated conditions related to the demonstration of equivalence for implantable and Class III medical devices in the EU. You can access the guidance here.
MDCG shares guide on demonstrating equivalence for Annex XVI products
MDCG 2023-6 covers the demonstration of equivalence, based on data pertaining to an already existing device, for the purpose of CE-marking under the MDR. It’s applicable to products without an intended medical purpose listed in Annex XVI of MDR and covered by the CS. You can read the full guidance here.
Guidance on qualification and classification of Annex XVI devices
MDCG 2023-5 provides useful advice for the qualification of a device as a product without an intended medical purpose listed in Annex XVI of the MDR. It also provides explanations and examples for the application of certain classification rules for products without an intended medical purpose. Find out more here.
MDCG updates Q&A on clinical investigations under MDR
The MDCG has updated its Q&A regarding clinical investigations for devices conducted according to MDR. The questions included in MDCG 2021-6 Rev. 1 cover general topics related to clinical investigations and appropriate regulatory pathways, as well as application content, modifications to clinical investigations, timeline considerations for clinical investigations, clinical investigation reports, arrangements for the transitional period, and legal representative. Access the full Q&A here.
EU Commission designates EU reference labs for high-risk IVD medical devices
On 5 December 2023, the EU Commission adopted an implementing act designating five EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices. These EURLs will be involved in conformity assessment of high-risk (class D) IVDs, and will carry out certain advisory tasks. Together, the designated EURLs cover the following categories of class D IVDs:
- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
The EURLs are expected to take up their tasks in conformity assessment of devices from 1 October 2024. Find out more on this here.
MDCG updates guidance on Article 15 MDR and IVDR regarding PRRC
MDCG 2019-7 – Rev.1 includes clarifications on qualifications related to manufacturers, roles and responsibilities of the PRRC, manufacturer, and authorised representative, as well as clarification on qualifications regarding Authorised Representatives, and registration of the PRRC in Eudamed. You can read the full guidance here.
Swissmedic shares information sheets on clinical investigations with medical devices & performance studies with IVDs
At the end of last year, Swissmedic released two information sheets: BW600_00_015e_MB is intended for sponsors of clinical investigations of medical devices, contract research organisations (CROs), and investigators, and provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance of clinical investigations by Swissmedic. BW600_00_016e_MB is intended for sponsors of performance studies with IVDs, contract research organisations (CROs), and investigators, and provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance by Swissmedic.
MedTech News from the US & Canada
eSTAR program now available for PMAs
In December 2023, the FDA’s eSTAR program was made available for voluntary use for certain Premarket Approval Applications (PMAs). The submission types now available include original PMAs, PMA Panel Track Supplements (PTS), PMA Real-Time (RT) Supplements, and PMA 180-Day Supplements.
To find out more about the eSTAR Program, see here.
Final guidance released on sterility information in 510(k) submissions
The FDA has released final guidance that updates and clarifies information on the sterilization processes it recommends to include in 510(k)s for devices labelled as sterile. The guidance also provides details about the pyrogenicity information to include. You can access the full final guidance here.
FDA shares draft guidance on 510(k) Third Party Review Program and EUA requests
The draft guidance outlines FDA’s expectations regarding the review of 510(k) submissions and EUA requests by third party review organisations.
The document provides updated recommendations on the 510(k) Third Party Review Program previously discussed in the 2020 final guidance, “510(k) Third Party Review Program.”, which will remain in effect until this draft guidance is finalised. You can read the draft guidance here, and submit comments until 20 February 2024.
Medical device export documents to now be issued electronically
On 2 January 2024 the FDA’s CDRH began issuing electronic export documents for medical devices. The transition from paper to electronic PDF aims to improve the efficiency of issuing export documents, accelerate the delivery of export documents to manufacturers, and decrease environmental burden. Find out more about which documents will now be electronically issued here.
FDA advises on use of DHTs in clinical investigations
To support a move towards improved efficiency and accessibility for clinical investigations, in December, the FDA released final guidance providing recommendations on the use of digital health technologies (DHTs) to remotely acquire patient data from participants in clinical investigations that evaluate medical products. You can read the full final guidance here.
FDA creates new Digital Health Advisory Committee
The FDA is establishing a Digital Health Advisory Committee as part of its strategy to support safe and effective regulation of digital health technologies (DHTs). Soliciting views from technical and scientific subject matter experts from diverse disciplines and backgrounds, the Committee will advise the Commissioner of Food & Drugs on issues related to DHTs, including related FDA policies and regulations, and the use of DHTs in clinical trials or post-market studies. Find out more about the new Committee here.
CDRH Portal updated to facilitate premarket submissions tracking
The FDA has updated CDRH’s Customer Collaboration Portal (CDRH Portal) to help users track the progress of their De Novo classification requests. The portal now facilitates the ability for a user to track their supported submission types during user fee holds and/or format holds for 510(k) originals, De Novo originals, Pre-Sub originals, and Pre-Sub supplements. Find out more about the portal updates here.
Health Canada revises MDEL application form
On 4 December 2023, Health Canada’s Regulatory Operations and Enforcement Branch revised the medical device establishment licence (MDEL) application form to include an updated definition from the medical device establishment licensing guidance (GUI-0016) and updated instructions for amendments. Information related to medical device shortage reporting and changes to the information on small business mitigation and fees was also added. Read more about the form updates here.
Health Canada amends Medical Devices Regulations to address future public health emergencies
On 3 January this year, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) came into force. These regulations broaden the scope of Part 1.1 to apply to future public health emergencies for which there’s an urgent public health need. Read more on the amendments here.
Regulatory reform & guidance from the UK
MHRA sets out regulatory roadmap to support safe access to MedTech
On the 9 January the MHRA revealed new plans to protect patient safety and enable faster access to innovative medical technologies.
The new ‘roadmap’ sets out a route to deliver enabling regulations via a series of new Statutory Instruments (SIs) for transformative technologies such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease, with core elements of the new framework intended to be in place by 2025. Find out more on this here.
Guidance on notifying MHRA about clinical investigations updated
The UK’s MHRA has updated its guidance on how to notify them of the intention to carry out a clinical investigation for medical devices. The recent updates include:
- The addition of a template for submitting Quarterly Summary Reports
- The addition of a PDF on the MHRA’s electrical guidance for clinical investigations
- The addition of a ‘Tabular Summary input” template for non-marked IVD devices
Guidance on registering medical devices updated
The MHRA’s guidance on registering medical devices for the Great Britain and Northern Ireland markets has been updated to include the following:
- An updated Account Management Reference Guide & Device Registration Reference Guide
- An updated video for registering a custom-made medical device
- A reminder concerning legislation requirements for custom-made devices
- Clarification concerning fees and actions required to change legislation of a registered device
IVD update from China
NMPA publishes IVD guidelines
On 3 January NMPA published twelve guidelines for in vitro diagnostic reagents-related products. To access the full list of guidelines, see here.
That concludes our December – January MedTech news roundup. Check back in February for more medical device news and updates.
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