Our March 2023 MedTech news roundup includes the latest on the EU MDR extension, Swiss Medtech’s Annual Report, and the MHRA’s overhaul of clinical trial regulation, as well as updates from Swissmedic and the FDA. Read on for more…
EU Parliament formally adopts proposal for MDR extension
European Parliament has adopted the EU Commission’s proposal for MDR and IVDR amendments regarding transitional provisions for certain medical devices and IVDs.
The main changes, which include the extension of the transitional periods for existing products according to a risk-based approach as well as the abolition of the “sell-off” deadline, will allow notified bodies and manufacturers more time to certify medical devices under MDR and IVDR, and as such, aim to mitigate the risk of device shortages. Find out more on this here.
Swiss Medtech publishes 2022 Annual Report
Earlier this month Swiss Medtech published its Annual Report. Whilst acknowledging the demanding environment triggered by Switzerland’s third-country relationship with the EU, Europe-wide problems regarding MDR implementation, and import hurdles relating to the revised national Medical Device Ordinance (MepV), Swiss Medtech also reports positive news – sharing how the last two years have seen the creation of around 4,500 new jobs in the MedTech sector in Switzerland.
Encouraging the industry to “defy the demanding environment” with “strength, agility, and innovation”, the annual report reflects on challenges faced in 2022 and the strategic goals regarding Switzerland’s long term attractiveness as a MedTech location. It also outlines key developments relating to Swiss Medtech last year such as the organisation’s expansion activities in Italian-speaking Switzerland. You can access the full report here.
UK’s MHRA announces biggest overhaul of clinical trial regulation in 20 years
The UK’s MHRA intends to streamline clinical trial approvals in the biggest overhaul of trial regulation in two decades.
The legislative changes aim to position the UK as one of the best countries in the world to conduct clinical research for patients and researchers, with the reforms to the UK clinical trials regulatory framework set to focus on patient safety and broader inclusivity, as well as the development of a proportionate, streamlined, flexible, and effective clinical research environment. Find out more here.
MDCG shares work in progress update regarding MDR & IVDR guidance
MDCG has shared a “work in progress” document regarding ongoing guidance related to MDR and IVDR. Areas covered in the update include notified bodies oversight, standards, clinical investigations & evaluation, post-market surveillance & vigilance, market surveillance, new technologies, UDI, IVDs, and nomenclature. Access the full update here.
Swissmedic introduces technical standard eCTD v4.0 for combination products
Swissmedic has shared a technical standard developed by the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). eCTD v4.0 relates to the submission of applications for the authorisation of medicinal products, including combination products. It’s a further development of the eCTD v3.2.2 standard which is currently valid.
Swissmedic intends to introduce the new version of the standard in stages. The first step involves the publishing of the Implementation Guide which provides the basis for the technical implementation. The following step covers the preparation of the technical infrastructure necessary for Swissmedic to receive and assess applications for eCTD v4.0.
Submissions according to both standards will be possible during a transitional period of several years that has yet to be defined. For more information, take a look here.
MHRA granted £10m to fast-track access to cutting-edge medical products
HM Treasury has awarded a total of £10 million to the UK’s MHRA to help accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as those made and approved by other trusted regulatory partners globally.
Over the next two years, the funding will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments such as cancer vaccines and AI-based therapeutics for mental ill-health. Read more on this here.
FDA highlights differences between standards in laser product final guidance
The recently published final guidance document describes the FDA’s approach regarding manufacturers’ compliance with FDA’s performance standards for laser products, and highlights the significant differences in some clauses within the related IEC standards.
Whilst there are many similarities between the FDA’s laser performance standards and the related IEC standards on laser products (namely IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1), there are some clauses that differ significantly. You can find out more and access the final guidance here.
FDA shares final guidance on medical x-ray imaging devices
The final guidance describes FDA’s policy regarding the regulation of medical x-ray imaging equipment that’s subject to the FD&C Act and FDA’s regulations that apply to medical devices and electronic products. The guidance aims to harmonize performance standards in Section 534, Subchapter C of the FD&C Act with IEC standards, to help ensure more efficient and consistent regulatory review of submissions for these products.
The FDA has determined that industry conformance to certain IEC standards would provide, at a minimum, the same level of protection of public health and safety from electronic radiation as certain EPRC regulatory standards. Access the final guidance here.
FDA shares recommendations for ultrasonic diathermy devices 510(k) submissions
The FDA has published final guidance that outlines recommendations for 510(k) submissions for ultrasonic diathermy devices, also known as physiotherapy devices. The guidance includes recommendations on the use of certain IEC standards in generating information that can support 510(k) submissions for these devices. Find out more here.
Marketing clearance of diagnostic ultrasound systems & transducers: FDA final guidance
The FDA has published final guidance that provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. As well as outlining regulatory approaches for certain diagnostic ultrasound devices, the guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new 510(k). Read the final guidance here.
FDA updates CDRH Portal
The FDA’s CDRH Portal allows users to send and track medical device premarket submissions online. This month the FDA updated the CDRH Portal to improve access to certain information. Organisations may now add more users to view the status of 510(k) submissions, users can now filter and sort the list of submissions via the Portal home page, and a new CDRH Portal Help section provides users with common questions and information about new features. Find out more here.
That concludes our March 2023 MedTech news roundup. Check back in April for more medical device news and updates.
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