Our July 2023 MedTech news roundup covers the latest from Swiss Medtech on utilising FDA authorised medical devices in Switzerland, a personnel update from Swissmedic, an amendment from the EU Commission on MDR transitional provisions, and an addendum from the MDCG on MDR application to legacy devices.
You’ll also find guidance from the FDA on MDDTs and premarket submissions for patient-matched guides to orthopaedic implants respectively, as well as news from the UK’s MHRA on CE marked medical devices, and from Australia’s TGA regarding an extension for medical device reform deadlines.
Read on for more…
Swiss Medtech shares expectations for implementation of motion to recognise FDA approved medical devices in Switzerland
Last November, Swiss Parliament passed a motion to increase room for manoeuvre in the procurement of medical devices for the care of the Swiss population. The motion tasks the Federal Council with amending national legislation so that Switzerland recognises medical devices from non-European regulatory systems with comparably strict requirements – in particular medical devices authorised for the US by the FDA.
On 30 June this year, Swiss Medtech published its expectation for the Federal Council to implement the parliamentary mandate swiftly and efficiently, and to observe three key principles:
- Medical devices authorised in the USA may be utilised in Switzerland.
- National laws will only be adapted where absolutely necessary.
- The underlying concept can be applied for other non-European systems.
Read more on the principles here.
Swissmedic appoints new Chief Medical Officer
On the 1st of this month, Claus Bolte was appointed Chief Medical Officer at Swissmedic. The newly created role sees Mr Bolte primarily tasked with developing clinical and regulatory scientific issues on a strategic level, as well as following up relevant developments at national and international level on behalf of the Executive Director and the Management Board.
Claus Bolte has taken on this role for a temporary two year period, following eight years at Swissmedic as Head of the Authorisation Sector.
Find out more about the appointment here.
EU Commission amends implementing regulation on MDR transitional provisions
On 20 June, the EU Commission passed the Commission Implementing Regulation (EU) 2023/1194 amending Implementing Regulation (EU) 2022/2346 regarding the transitional provisions for certain products without an intended medical purpose listed in the MDR Annex XVI.
Read more about the types of medical devices included in the amendment here.
MDCG publishes addendum to paper on MDR application to legacy devices
The MDCG has published an addendum to its Position Paper on the application of Article 97 of the MDR to legacy devices.
Published in December 2023, the position paper MDCG 2022-18 aimed to help avoid supply disruptions of devices on the EU market. It provided a uniform approach to the application of Article 97 of the EU MDR in situations where a certificate issued under MDD or AIMDD expires before issuance of the necessary certificate(s) in accordance with the MDR. The use of Article 97 in these situations was intended as a temporary solution.
Since the MDR transitional period and the validity of MDD/AIMDD certificates has been extended (as a result of Regulation (EU) 2023/607 entering into force on 20 March this year), the imminent risk of critical legacy device shortages related to the expiry of MDD/AIMDD certificates has been averted.
As such, the application of Article 97 MDR in accordance with MDCG 2022-18 has achieved its objective and is deemed no longer relevant by the MDCG. Read more on the addendum here.
UK’s MHRA continues to accept CE marked medical devices
The MHRA has announced that CE marked medical devices will continue to be accepted on the Great Britain market after 30 June this year.
The Government’s regulations that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023, mark the first statutory instrument in a series that’s planned to implement a strengthened regulatory framework for medical devices.
Later this year, the MHRA intends to continue the series with a statutory instrument that’ll lay down enhanced post-market surveillance requirements.
See here for more information.
FDA releases final guidance on qualification of MDDTs
The final guidance from the FDA describes a voluntary program for the qualification of medical device development tools (MDDTs) for use in the evaluation of devices regulated by CDRH.
Aiming to create efficiencies in the evaluation of medical devices, the guidance describes the framework for voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package.
Access the final guidance here.
CDRH to transition from paper to electronic export documentation for medical devices
From 2 January next year, the FDA’s CDRH will be transitioning from paper export documents for medical devices to electronic export documents. Documents to be issued electronically include:
- Certificate to Foreign Government,
- Certificate of Exportability Section 801(e)(1) or 802,
- Non-Clinical Research Use Only Certificate,
- Certificate to Foreign Government for Device Not Exported from the United States, and
- Export Permit Letter.
All certificate requests received by 15 December this year will be issued as paper certificates, as will those requests received after 16 December if the review is completed prior to 2 January 2024. All requests received after 2 January 2024 will be issued electronically.
FDA shares draft guidance on premarket submissions for patient-matched guides to orthopaedic implants
The draft guidance document provides the FDA’s recommendations on information to support premarket submissions for patient-matched guides to orthopaedic implants. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of submissions.
The guidance also provides recommendations for manufacturers to consider when developing their design process for these device types.
Australia’s TGA extends deadlines for medical device reforms
Due to the impact of the EU MDR transition, the Australian Government recently agreed to extend the deadlines for several medical device reforms underway in Australia.
Regulatory amendments are progressing and are expected to be in place this year. The extended deadlines intend to give manufacturers time to obtain an EU MDR certificate before the end of the EU MDR transition on 31 December 2028, and for sponsors to use the MDR certificate to apply to the TGA before 1 July 2029.
That concludes our July 2023 MedTech news roundup. Check back in August for more medical device news and updates.
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