October 2023 – Medical Devices Regulatory Insights

Medtech Could Help Address EU’s Worsening Healthcare Workforce Crisis

Belgium, when it takes over the presidency of the Council of the European Union in January 2024, intends to make the EU’s worsening healthcare workforce crisis “one of the main priorities at the EU level for the upcoming years and the next Commission.”.

That is according to Health Policy Watch, a nonprofit independent global health reporting platform, which also points out that countries in the WHO’s European region currently face a shortfall of 1.8 million health workers. That number is expected to double to 4 million by 2030.

This clearly highlights the importance for medtech companies of developing products that help solve some of the shortfalls created by lack of staff and that offer smart care.

AI, telemedicine, remote patient monitoring and robotics are among the new technologies that offer promise here. But the growing mountain of overlapping regulations in this area is making innovation difficult and costly. Indeed, Medtech Insight notes, it will be important that the
sector becomes part of the dialogue that will be taking place.

Appalling Workforce Retention Statistics

A myriad of complex issues contribute to the large gap between supply and demand in healthcare in the EU itself. One major contributor to the problem is workforce retention. “Europe’s medical and nursing graduate output has outpaced workforce growth by 29% and 4%, respectively,” Health Policy Watch reports.

This is not a good outcome given the rapidly ageing population and the demands they place on the system. But it is not surprising that healthcare workers are leaving the sector in droves because of the low pay and high stress. Many have also decided they no longer wish to work in the environment following their stressful experiences working during the COVID-19 pandemic.

Internal dialogues held by Belgian delegations with EU health ministers to determine the priorities of the country’s presidency, Health Policy Watch reports, found that the health workforce crisis is the “main headache for basically all health ministers in the EU and in the WHO European region.”

Original source: Medtech Insight. Published: 9 October 2023.
Full article: https://medtech.citeline.com/MT148332/MedtechCould-Help-Address-EUs-Worsening-Healthcare-WorkforceCrisis?vid=Pharma

Guidance documents issues by the Medical Device Coordination Group (MDCG)

MDCG has issued some guidance documents over the past few months which include a list of standard fees, In Vitro Diagnostic medical devices, and the MDR transitional period.

July 2023

Q&A Rev. 1: Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “sell off” periods

September 2023

Q&A: Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR

Manual on Borderline: Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3

MDCG 2020-3 Rev.1: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

UK MHRA Announces Three New Approved Bodies to Certify Medical Devices

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices.

UK Approved Bodies

Under the current UK legislation, before a manufacturer can place a UKCA-marked medical device on the market in England, Wales and Scotland, they must secure UKCA marking from a UK Approved Body. This applies to all medical devices and IVDs, except those of the lowest risk
classification (i.e., Class I medical devices without sterile/measuring functions and general IVDs).

Before appointing a UK Approved Body, the MHRA conducts a detailed assessment to ensure that the organization meets the relevant requirements. Once all conditions are satisfied, the MHRA will designate that organization as a UK Approved Body for a maximum period of five years, during which time they are regularly monitored to ensure they continue to meet the requirements.

New Designations

TÜV SÜD, Intertek, and TÜV Rheinland UK have now been added to the list of four previously designated UK Approved Bodies, bringing the total number to seven. All three have been designated as UK Approved Bodies to assess and certify general medical devices in accordance
with Part II of the UK Medical Devices Regulations 2002, while TÜV Rheinland UK has also been designated to assess and certify IVDs in accordance with Part IV of the UK MDR 2002.

Original source: EMERGO. Published: 5 September 2023. Full
article: https://www.emergobyul.com/news/uk-mhra-announces-three-new-approved-bodies-certify-medical-devices

eSTAR Program

As of October 1, 2023 all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR, as noted in the final guidance: Electronic Submission Template for Medical Device 510(k) Submissions.

eSTAR is the only available electronic submission template to prepare 510(k) electronic submissions.

eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. eSTAR provides the following benefits:

• Guides the submitter to ensure they provide the necessary details for the submission.
• Complements the reviewers’ internal Submission Memo And Review Template (SMART) used to review the submission (the questions correlate), so the reviewer is getting what is expected.
• Provides a standardized format to make information accessible for the reviewer and submitter.
• Automates many aspects of the submission to ensure the content is present, eliminating the need for a Refuse to Accept (RTA) review by the reviewer and RTA holds. The FDA does not intend to conduct an RTA review for an eSTAR submission.
• Auto fills entered information to avoid entering the same information twice.
• Includes built-in databases to ensure the information relevant for device specific guidance, classification identification, and standards information are auto filled accurately.
• Includes built-in forms (Truth & Accuracy statement, Form 3514, 510(k) Summary, Declaration of Conformity, and the Indications for Use Form 3881).
• Collects submission data in a structured format to help automate many aspects of FDA processing.
• Serves as a comprehensive resource to consolidate the necessary information and links needed for submission preparation.

Original source: FDA. Published: 2 October 2023 Full article:
https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program

LDT Rule Will Have Massive Impact, Analysts Say; Fundamental Questions Remain

It’s no surprise the Food and Drug Administration decided to flex its regulatory muscle over laboratory-developed tests (LDTs) – Commissioner Robert Califf has made it clear for a year now that the agency’s rulemaking authority was on the table; and when Congress failed to act on diagnostic reform last year, it almost became a certainty the FDA would do so unilaterally.

As recently as August, Califf was blunt: “We’re going down the pathway of a rule, let me be clear about that,” he said during an Alliance for a Stronger FDA webinar. (Also see “FDA Going Down ‘Pathway’ Of A Rule On LDTs, Califf Says” – Medtech Insight, 23 Aug, 2023.)

But what is surprising about the proposed rule is that the FDA took a more aggressive approach than anticipated. According to a report by John Leppard, a health care analyst with the Washington, DC, research firm Washington Analysis, the rule includes a requirement for
LDTs to undergo premarket approval (PMA) and 510(k) reviews, which disregards prior iterations that would allow currently marketed tests to forego these requirements.

Instead, the rule proposes that all high-risk LDTs submit a PMA no sooner than 1 October 2027 with low- and moderate-risk tests required to submit a 510(k) on or after 1 April, 2028. (Also see “Proposed Rule Would Apply FDA’s Diagnostic Rules To LDTs” – Medtech Insight, 29 Sep, 2023.)

Leppard says this harder line contrasts with previous guidance and discussion drafts from the FDA – “as well as even congressional efforts” – at LDT regulation.

“The agency now appears to largely dismiss industry criticisms that regulatory oversight of currently marketed tests will stymie innovation, impose an undue burden on industry, and disrupt patient access to in vitro diagnostics,” Leppard explained, opining this will likely be most controversial aspect of the rule during the upcoming comment period, which run through 1 December.

Original source: Medtech Insight. Published: 5 October 2023.
Full article: https://medtech.citeline.com/MT148322/LDT-Rule-Will-Have-Massive-Impact-Analysts-Say-Fundamental-Questions-Remain

Canada Updates 18-Year-Old Guide On What Constitutes Advertising

How long can manufactures operating in Canada keep press releases about their health care products posted on their website landing page, and when would corporate messages be considered promotional?

These are among the raft of topics that Health Canada has addressed in new guidance that will replace its 18-year old guidelines on distinguishing between advertising and other activities.

The updated guidance, which now applies to medical devices as well as drugs, explains which forms of communication or activities would be considered promotional and therefore subject to advertising provisions in Canadian health care product legislation.

It also includes a new section on the use of social media and technology.

The new guidance states that a press release or information disseminated at a press conference may be considered promotional if, for example, the announcement is kept on the manufacturer’s Canadian website landing page for more than a year and is not archived.

For corporate messages, it says that including information beyond the name and therapeutic area of a health product may render the message promotional, except if such information is required to be provided by law, for example, in securities filings.

Why The Distinction Is Critical

Health Canada notes that it is critical to determine whether the purpose of a message is to promote the sale of a health product or to provide information.

While it is important for industry to disseminate non promotional, accessible information on human and animal health products to health care professionals and the general public, there are numerous provisions in the Food and Drugs Act, the Controlled Drugs and Substances Act
and their respective regulations that apply to health product advertising, says Health Canada.

As such, it is necessary to determine whether a message or activity would be considered to be non-promotional in nature and, therefore, not in violation of the prohibitions against the advertising of health products set out in the legislation.

For example, sections 9(1) and 20(1) of the Food and Drugs Act prohibit advertising any drug or device in a manner that is:

• false, misleading or deceptive; or
• likely to create an erroneous impression regarding its character, value, quantity, composition, merit, design, construction, performance, intended use or safety.

Original source: Medtech Insights Published: 23 August 2023.
Full article: https://medtech.citeline.com/MT148204/Canada-Updates-18-Year-Old-Guide-On-What-Constitutes-Advertising

TGA seeks feedback on educating Australian healthcare about unique device identification

Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on its draft plan for educating the healthcare system about unique device identification (UDI).

TGA was aiming to achieve voluntary compliance with UDI requirements by July but deferred the date because of a legislative hold-up. The regulator is yet to set new timeframes for voluntary or mandatory compliance but with UDI requirements planned in Australia and in place overseas, it expects healthcare providers to start seeing medical devices that carry the identifiers.

To prepare the sector, TGA is drafting a document intended to educate healthcare providers about the key concepts of UDI and highlight the importance of adopting the identifiers within their organizations. TGA released version 0.3 of the draft document for consultation last week.

The draft includes an overview of what UDIs are and how they will affect healthcare, as well as a closer look at the Australian system. TGA is accepting feedback on the draft until 31 October.

Original source: Regulatory Focus. Published: 2 October 2023.
Full article: Asia-Pacific Roundup: Singapore’s HSA gives industry a year to comply with new drug substance evidence requirements | RAPS

Funding

The Innovative Devices Access Pathway (IDAP) – pilot phase

The aim of IDAP is to enable and improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers.

8 successful applicants will receive support at key stages of their product design and development process from the IDAP partners.

The IDAP Offering

• quality management system support
• system navigation advice
• a fast-tracked clinical investigation
• joint scientific advice with partners
• support with Health Technology Assessments (HTA) for product realisation and adoption
• safe-harbour meetings to discuss NHS adoption
• exceptional use authorisation granted by the MHRA, provided necessary safety standards
  are met

Eligibility

The eligibility and innovation criteria will need to be met for successful entry to the IDAP pilot. The IDAP partners will select 8 products that best meet those criteria and are most likely to benefit from the expertise and tools available in the pilot.

How to apply

To join the program, you need to complete the IDAP pilot application via GovForms.

You must complete the form in one session as progress cannot be saved. To prepare evidence in advance, you can download a template of the form.

The application will require the completion of seven parts.

Important dates

• Pilot live for applications 25 September 2023 00:00 BST
• Submission deadline 29 October 2023 23:59 BST
• IDAP pilot notifications from December 2023
• Target Development Profile engagements from January 2024

Original source: GOV.UK. Published: 19 September 2023. Full article https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase

Horizon Europe: Help for UK Applicants

Horizon Europe is an EU research and innovation programme. It has a budget of €95.5 billion and runs until 2027.

The UK agreed a deal to associate to Horizon Europe on 7 September 2023.

UK researchers can now apply for Horizon Europe funding, certain that all successful UK applicants will be covered through the UK’s association (or through the guarantee) for the remainder of the programme.

All calls in Work Programme 2024 will be covered by association, and the UK guarantee scheme will be extended to cover all calls under Work Programme 2023.

In summary, Horizon Europe funding is available for:

• excellent research in any field
• researcher mobility
• research infrastructure
• global challenges and industrial competitiveness including:
  o health
  o culture, creativity and inclusive society
  o civil security for society
  o digital, industry and space
  o climate, energy and mobility
  o food, bioeconomy, natural resources,
  agriculture and environment
• innovation
• the development of the European research and
  innovation systems

As a UK applicant, help is available so you can make the most of Horizon Europe. Find out where to get guidance and help.

Original source: UK Research and Innovation. Published: 18 September 2023.
Full article: https://www.ukri.org/apply-for-funding/horizon-europe/

Government to invest £30 million in innovative technology for NHS

The technology will help cut waiting lists, speed up diagnosis and deliver new and improved ways to treat patients.

• Integrated care systems (ICSs) will be invited to submit bids for a share of £30 million to roll out innovative technology
• Effective use of the latest medical technology can help cut waiting lists, with the potential to speed up diagnoses and improve care for patients
• Technology could include virtual wards to help care for patients at home, or wearable devices to monitor chronic conditions remotely – easing winter pressures and supporting the workforce

Patients across the country will benefit from a £30 million government investment in innovative medical technology (medtech) which will help ease pressures on the NHS this winter and could include the expansion of 3D checks that speed up cancer tests and novel logistics solutions such as the use of drones.

Available to each region in England, ICSs – organisations that come together in local areas to deliver joined up health and social care services – will be able to invest in the latest technology
that can help cut waiting lists, speed up diagnosis and deliver new and improved ways to treat patients.

Depending on local need, ICSs could use the funding to expand virtual wards, allowing more patients to receive the care they need at home, freeing up hospital beds. Over 9,800 virtual ward
beds have already been created, and the NHS is on track to meet its target and deliver 10,000 ahead of winter.

ICSs could also invest in wearable medical devices for use by patients at home, to aid diagnosis and management of numerous chronic conditions – these devices allow the monitoring of vital signs such as blood oxygen levels, heartbeat and blood pressure. Alternatively, investing in digital 3D and other imaging technology could bolster diagnostic tests, supporting the NHS to detect and treat cancer and other serious illnesses earlier.

Original source: GOV.UK. Published: 19 September 2023.
Full article: https://www.gov.uk/government/news/government-to-invest-30-million-in-innovative-technology-for-nhs

Network Events

MedFit: 9-10 October 2023
Device Talks West: 18-19 October 2023
TOPRA Symposium: 23-25 October 2023
Project Medtech’s Startup Symposium: 25 October 2023
MEDICA:13-16 November 2023

Simplimedica will be exhibiting at MEDICA 2023. Come and see us for all your Quality and regulatory needs at hall 16 stand 16H21-8 at the Medlink Pavilion

CTRMD2023: 20-21 November 2023
Warsaw Medical Expo: 6-8 December 2023
Medicall Kolkata: 8-10 December 2023

References
Image 1:
https://www.sciencepharma.com/news/medical-device-regulation-regulatory-aspects,p534672316
Image 2:
https://www.medtecheurope.org/wp-content/uploads/2022/05/20220513_eu_ivdr_impact_changes_int_reg_ed.2_final_pub.pdf
Image 3:
https://www.tctmd.com/news/fda-green-lights-empagliflozin-hf-reduced-ejection-fraction
Image 4:
MHRA cuts could affect UK regulatory decisions, say unions | pharmaphorum