July 2023 – Medical Devices Regulatory Insights
MDCG Recommends Limits on Article 97 MDR Applications by EU Member States
European regulators are recommending that European Union member states should limit use of Article 97 Medical Devices Regulation (MDR) to particular circumstances involving legacy medical devices now that amendments extending MDR transition periods have been published.
On July 1, 2023 the Medical Devices Coordination Group (MDCG) published an addendum to the previously published MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.
In short, the addendum clarifies that with the adoption of the amendment to the MDR, Regulation (EU) 2023/607, the application of Article 97 MDR by EU member-states should be limited to “very exceptional situations”.
What was MDCG 2022-18 about, again?
MDCG 2022-18 was published December 2022, and aimed at avoiding disruption of the supply of devices in the EU and avoiding discontinuation of healthcare as a result of an expected bottleneck of expiring certificates by May 26, 2024.
MDCG 2022-18 was a guide for manufacturers and EU Member-states “to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the
MDR because its certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.”.
Article 97(1) MDR allows manufacturers and EU Authorized Representatives to request that a Competent Authority (CA) permits a device on the EU market that is not (yet) fully compliant with the MDR. Before the amendment to extend the MDR transitional provisions was published (Regulation (EU) 2023/607), legacy devices that had not yet received the final CE certificate to the
MDR, while the MDD or AIMDD certificate had already expired, were no longer allowed on the market in the EU.
Article 97 MDR decisions could be issued by CAs to allow a device on the EU market for a limited time until the MDR certificate is issued or any non-compliance issue was solved. Article 97 MDR was intended as a bridging solution until Regulation (EU) 2023/607).
With the publication of Regulation (EU) 2023/607 on March 20, 2023, MDCG 2022-18 lost its main purpose: “avoiding disruption of supply of devices on the EU market needed for health systems and patients”.
The addendum that has been added to MDCG 2022-18, states that Article 97(1) MDR decisions should only be made in very exceptional situations.
Original source: EMERGO by UL. Published: 5 July 2023. Full article:
https://www.emergobyul.com/news/mdcg-recommends-limits-article-97-mdr-applications-eu-member-states
EU MDR costs could cause device shortages for children, medical groups warn
European regulators voted earlier this year to extend the transition period for the Medical Devices Regulation (MDR) to 2027 or 2028, depending on a device’s risk category.
However, the deadline for submitting devices to certification organizations, known as notified bodies, is much sooner. Manufacturers need to submit applications to a notified body by May 2024 and have a contract in place by September 2024 to be able to market their devices.
The cost of this process “forms a critical financial barrier for manufacturers” to introduce, or re-introduce, devices in the EU market, the medical associations warned in a letter. For example, one company with a single device received invoices of 800,000 Euros for a conformity assessment, which would allow it to be on the market for five years, they wrote. By comparison, 510(k) clearance in the U.S. costs roughly 5,000 Euros.
Some types of devices are already facing shortages, the letter writers warned. Balloons used to treat certain congenital heart defects in new-born infants have become unavailable, and shortages have been reported for dialysis machines used to treat young children with end-stage kidney disease.
The groups suggested establishing an EU-wide system to monitor whether specific medical devices are about to disappear from the market and creating a status designation for “pediatric” or “orphan” devices that could result in faster and cheaper conformity assessments In the interim, the associations recommended automatically granting permission for continued use of high-risk pediatric or orphan medical devices that have been on the market for at least three years without reported problems.
Original source: Medtech Dive. Published: 29 June 2023. Full article:
https://www.medtechdive.com/news/MDR-shortage-pediatric-devices/654302/
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.
January 2023
MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2023-2: MDCG 2023-2 MDR form: MDCG 2023-2 IVDR form: List of Standard Fees
February 2023
MDCG 2020-16 Rev.2: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
March 2023
Q&A: 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
May 2023
2023/C 163/06: Commission Guidance on the content and structure of the summary of the clinical investigation report
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
June 2023
MDCG 2022-18 ADD.1: MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – Addendum 1
Timeframe for accepting CE marked medical devices in Great Britain extended
The Government has made regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023.
This measure aims to support the ongoing and safe supply of medical devices within Great Britain and facilitate a smooth transition towards a future strengthened regulatory framework for medical devices.
It is the first statutory instrument in a series that are planned to implement the strengthened framework. Next in the series, the MHRA intends to lay a statutory instrument later this year that will put in place enhanced post-market surveillance requirements.
Core aspects of the future framework for medical devices are intended to apply from 1 July 2025. This timeline is subject to ongoing review as the MHRA continues to monitor feedback from external stakeholders, for instance on the capacity of conformity assessment bodies.
Original source: GOV.UK. Published: 1 July 2023. Full article:
https://www.gov.uk/health-and-social-care/medicines-medical-devices-blood-medical-devices-regulation-safety
Countdown Starts On Great Britain’s Move To Accept Medtech Registered Overseas
There are some 15-18 months at the outside – before the UK government must hold the next general election. The political consensus points to an autumn 2024 poll.
By that time, the government – represented by the Department of Health and Social Care (DHSC) and UK Medicines and Healthcare products Regulatory Agency (MHRA) − will have delivered international recognition for medtech products used in Great Britain.
That was the promise of minister of state Will Quince, as he addressed a 3 July parliamentary reception hosted by the Association of British HealthTech Industries (ABHI).
Industry will be called on to support the work needed to provide the future framework of approvals from other, trusted jurisdictions, the minister said. The government’s consultation on what international device recognition should comprise will start in October, coordinated by
MHRA chief healthcare quality and access officer Laura Squire.
MHRA Strategic Direction 2023-26
Confirmation of the timing of this significant device regulatory policy move for the UK, and potentially for other MedTech regulatory jurisdictions over time, came as the MHRA released a three-year corporate plan for the period. The plan outlines the agency’s strategic direction for 2023-26.
There are many timetabled initiatives set out in the plan, but the one covered by section 2.6 is the most far reaching. It promises that by 31 March 2025, Great Britain will have formalized new recognition pathways for UK device approvals that will complement existing national UK national routes to market.
The UK’s transition from EU member state to a country with a standalone sovereign medtech regulatory system “has brought home the importance of working in partnership with other regulators both nationally and internationally, “the agency noted.
It also acknowledged that it is “at a pivotal moment” in its evolution, as it presses for faster, risk-proportionate and more predictable regulatory pathways for the UK.
Accordingly, the agency will establish several new priority regulatory pathways for new medical products for:
- Diagnostics and genomics;
- Data science;
- Artificial intelligence (AI) and software as a medical device;
- Vaccines and immunotherapies; and
- Biotherapeutics, cell and gene therapies.
The task of delivering joined-up services has already started with the development of the AI and Digital Regulation Service. This will support the risk-proportionate regulatory approach and enable the MHRA to compete on a performance basis with other international regulators.
These pathways will provide a legal base to allow for expedited access for some medicines and medical devices where these have already been approved by trusted regulators, the corporate plan said.
Original source: Medtech Insight. Published: 10 July 2023. Full article: https://medtech.pharmaintelligence.informa.com/MT148078/Countdown-Starts-On-Great-britains-Move-To-Accept-Medtech-Registered-Overseas
Regulating AI as a medical device in the UK
The term ‘medical device’ is broadly defined and widely used. It has been estimated that there are currently around two million different kinds of medical devices available throughout the world, with the market expected to reach a valuation of USD964.9 billion by 2030. Although many
medical devices are low tech or have no electronic components, the ever-increasing rise and integration of technology into our daily lives is equally apparent in the medical device industry.
A concurrent combination of the growth of software capabilities and the shrinking size of hardware has led to a proliferation of electronic medical technology incorporating, or in some cases exclusively consisting of, software. For example, software that calculates clinical risk or offers a prognosis of future disease risk would constitute a medical device in its own right, even without the accompanying hardware. This is referred to as software as a medical device (SaMD).
Artificial intelligence (AI) can use machine learning to enhance the capabilities of software, by analysing and interpreting data. In practice within healthcare, this includes AI systems that can be trained to diagnose medical conditions, spot early cancer symptoms or predict cardiac arrest.
As explored in our overview of AI in healthcare, the UK’s national AI strategy focuses on a light-touch and flexible approach to AI regulation, relying on a framework that permits regulators to introduce sector-specific rules. In the UK, the Medicines and Healthcare products Regulatory
Agency (MHRA) is responsible for regulating the medical devices market. It is currently preparing detailed guidance on the regulation of AI as a medical device (AIaMD).
In September 2021, the MHRA announced its development of a work programme, the Software and AI as a Medical Device Change Programme, that will review the regulatory environment applicable to medical software and AI in the UK. This announcement was followed in October 2022 by a Regulatory Roadmap, which sets out how the MHRA intends to regulate medical software and AI in the UK, summarised in eleven ‘work packages’. AIaMD will be regulated as a part of SaMD, with no additional legislative medical device requirements being imposed on AI beyond those for software.
Original source: Taylor Wessing. Published: 4 July 2023. Full article: https://www.taylorwessing.com/en/insights-and-events/insights/2023/07/regulating-ai-as-a-medical-device-in-the-uk
FDA Alerts Industry On GUDID Compliance
The US Food and Drug Administration is sending out letters to alert device manufacturers to potential problems with information in the Global Unique Device Identification Database (GUDID).
The letters specifically address an apparent mismatch between device establishment registration and listing records and UDI information loaded into GUDID, says Sarah Fitzgerald, US program manager for Emergo by UL. Fitzgerald told Medtech Insight that the letters began to appear the week of 6 June. The consulting firm, which also serves as an official FDA correspondent for some device companies, has already seen dozens.
Most devices needed to be listed in GUDID by the end of 2022, but exemptions exist for certain categories such as custom devices and devices intended for use only outside the US, as well as most class I devices. (For a full list of exemptions, see the sidebar.) (Also see “Updated GUDID
Data Shows Product Details For 4M Devices” – Medtech Insight, 31 Jan, 2023.)
But Fitzgerald says the system-generated letters are being sent even to some companies with valid exemptions – possibly because the FDA’s process doesn’t seem to look for exemptions.
“We don’t have internal insight into the FDA, but what it appears to be is that they’re looking at the GUDID database, which is where a company is supposed to put all of the UDI information, and then the establishment registration and device listing, which is the other database that a company has to register with and saying, ‘Hey, these aren’t matching up,’” she says.
What should a company do if it has received one of these letters?
First, Fitzgerald says, the firm should check to see if it might fall under an exemption that the FDA failed to recognize. If that is the case, the company technically does not need to do anything – though Fitzgerald recommends that manufacturers take a minute to write a letter to the FDA explaining that they believe the product is exempt.
Original source: Medtech Insight. Published: 7 July 2023 Full article: https://medtech.pharmaintelligence.informa.com/MT148073/FDA-Alerts-Industry-On-GUDID-Compliance
FDA to transition to electronic export documents for devices in 2024
Starting next year, the US Food and Drug Administration (FDA) will transition key export documents for medical devices from paper to digital format to reduce paperwork and streamline their workflow.
Starting 2 January 2024, export documents for human medical devices that are regulated by the Center for Devices and Radiological Health (CDRH) will be issued electronically by FDA as downloadable PDFs from CDRH’s Export Certification Application and Tracking System (CECATS). The agency says the documents may then be validated by foreign governments and other entities who use the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) database. Companies can access the FECV online database from a web address or a QR code on the certificate.
“The change from paper to electronic PDF will improve efficiency in issuing export documents, reduce the amount of time it takes for a manufacturer to receive export documents, and decrease environmental burden,” said FDA.
The list of export documents 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
FDA will still issue paper certificates for all requests received by 15 December 2023, and those received after 16 December will only receive paper certificates if the review is completed before 2 January 2024. After that, all requests will be handled electronically by the agency.
Original source: RAPS. Published: 11 July 2023. Full article:
https://www.raps.org/News-and-Articles/News-Articles/2023/7/FDA-to-transition-to-electronic-export-documents-f
First Notified Body In Cyprus Named Under Medical Device Regulation
GFI Health Technology Certification, based in Nicosia, Cyprus, has been listed as the EU’s 39th notified body in the context of the EU Medical Device Regulation.
Its designation is limited to nineteen product codes and includes: reusable surgical instruments; devices incorporating medicinal substances (but excluding medicinal products derived from human blood or human plasma; class III custom-made implantable devices, but limited to orthopaedic and ophthalmological devices; devices incorporating software/utilizing software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices; and devices in a sterile condition as long as this has been achieved through certain types of sterilization.
GFI’s full range is available under its listing on the European Commission’s Nando website of notified bodies.
The listing states that its competence was assessed by the Swedish Board for Accreditation and Conformity Assessment, SWEDAC, and that the designation is valid until 6 July 2023.
The designation was notified by the Medical Devices Competent Authority’s Medical and Public Health Services to the European Commission.
Original source: Medtech Insights Published: 7 July 2023. Full article:
https://medtech.pharmaintelligence.informa.com/MT148072/First-Notified-Body-In-Cyprus-Named-Under-Medical-Device-Regulation
New guidance published on manufacturer evidence for IVD medical devices in Australia TGA no longer accepts ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a Declaration of Conformity under the EU IVD Directive before 26 May 2022.
IVD medical devices that are already approved for supply based on ISO 13485 certificates will need to transition to another form of acceptable manufacturer evidence once the certificate expires, to continue to supply in Australia.
This guidance helps sponsors identify the actions they must take to transition to new manufacturer evidence and ensure ongoing regulatory compliance.
Original source: OMC Medical. Published: 20 June 2023. Full article: https://omcmedical.com/june-newsletter-2023/
Malaysia MDA Update on Transition Period for the Use of Electronic Medical Device Registration Certificate
Malaysia MDA released an update on the use of Electronic Medical Device Registration Certificate starting 2 May 2023. Establishment can download the Medical Device Registration Certificate from MeDC@St2.0+ system once the application is complete (status complete) and paid the
registration fee.
Both physical and electronic Medical Device Registration Certificates can be used for the
purpose of importing or placing the medical device in Malaysia market. The transition period for the use of physical Medical Device Registration Certificate to electronic Medical Device Registration Certificate will last until 31 December 2023. Establishment can obtain the physical Medical Device Registration Certificate from MDA officer as per current practice and can download the electronic Medical Device Registration Certificate from MeDC@St2.0+ system during the transition period.
Starting from 1 January 2024, the electronic Medical Device Registration Certificate will be fully effective and MDA will no longer issue physical Medical Device Registration Certificate.
Original source: Pharma to Market. Published: 5 June 2023. Full article:
https://www.pharmatomarket.com/malaysia-mda-update-on-transition-period-for-the-use-of-electronic-medical-device-registration-certificate/
Anvisa publishes new medical device import manual
The new Manual for Importing Medical Devices is available on Anvisa’s portal . The document aims to guide importers on the rules for submission and procedures for analyzing import processes.
The subjects are organized into topics , which help consultation on the regularization of companies and products, procedural instruction and analysis and inspection procedures. The specific legislation and situations applicable to each topic are also indicated.
This publication is not intended to replace the guidelines on petitioning for the import process already published by the Agency or the manual available on the Siscomex Portal . The idea is to complement this information on specific aspects of consent to import medical devices in
the context of Anvisa.
Original source: OMC Medical. Published: 22 June 2023. Full article:
https://omcmedical.com/june-newsletter-2023/
References
Image 1:
https://www.sciencepharma.com/news/medical-device-regulation-regulatory-aspects,p534672316
Image 3:
https://www.tctmd.com/news/fda-green-lights-empagliflozin-hf-reduced-ejection-fraction
Image 4:
https://pharmaphorum.com/news/mhra-cuts-could-affect-uk-regulatorydecisions-say-unions
Image 6:
https://www.regdesk.co/malaysia-mda-complaints-and-problem-reporting/