April 2024 – Medical Devices Regulatory Insights

Update from MHRA on UK MedTech Regulatory Reform

The UK medical device regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), presented a webinar (March 5) on the upcoming changes to the medical devices legislation for Great Britain (GB). The webinar provided an update on the draft policy on scope, classification and essential requirements for medical devices, based on the government response to the 2021 consultation.

Scope of the Regulations

  • The scope is updated to account for advances in the field, improve patient safety and increase international alignment.
  • For general medical devices, new definitions will be provided for “medical device” and “intended purpose” to provide clarity for device users on how and when a device can be used and to reduce risks to patient safety associated with potential misuse.
  • For in vitro diagnostic (IVD) devices, software, companion diagnostics and genetic testing will be included in the scope, as will IVDs providing information about a physical or mental impairment.
  • Software as a medical device (SaMD) will be included with a new definition introduced and
    additional pre-market essential requirements implemented. NOTE: THE newly introduced
    definition for SaMD will be sufficiently broad to allow for flexibility of qualification and will include Artificial Intelligence (AI) as a subset.

It is interesting to note that, in a deviation from the EU Medical Devices Regulation (MDR 2017/745), products without a medical purpose will not be included in the Future Core regulation but are instead expected to be covered within the Future Enhancements regulation, following further stakeholder engagement.

Classification

  • The general medical devices classification will align to the MDR, with the addition of a rule for devices used in the process of in vitro fertilization (IVF) or assisted reproduction technologies (ART), where these substance-based devices, that come into direct contact with human embryos before implantation, will be Class III medical devices.
  • For SaMD that are general medical devices and not IVDs, the MHRA will adopt the risk
    categorization in the IMDRF Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations for classification, resulting in the four-tier risk categories (I-IV) aligning with risk classifications I-III, as per Rule 11 of the MDR.
  • For IVDs, classification will move to a risk-based classification system based on IMDRF N64FINAL:2021, providing close alignment to the MDR, with only minor modifications. Also, there will be UK-specific additions for devices monitoring infectious loads of life-threatening infectious diseases, such as Ebola virus (Class D), and devices with the intended purpose of screening, detecting or diagnosing neurodegenerative or cardiovascular diseases such as dementia or stroke (Class C).

Essential Requirements

Accelerated EUDAMED implementation Essential Requirements will be aligned with the General
Safety and Performance Requirements (GSPRs) in the MDR and EU In Vitro Diagnostic Devices Regulation (IVDR 2017/746) but will be tailored to the domestic context (i.e., references to EU laws and provisions will be replaced by the equivalent GB adaptation).

In terms of timelines, while no definitive dates were discussed, reference was made to the roadmap published earlier this year, which provides an overview of the planned activities. It was also stated that the MHRA has no intent to delay implementation of future regulations. It
was emphasized that certain actions incorporated in the roadmap are dependent on other priorities outside the MHRA’s control. Furthermore, the upcoming UK General Election, due to take place before January 28, 2025, may also affect the current timelines

Original source: EMERGO by UL. Published: 6 March 2024.

European Commission Proposes Amendments to Medical Device Regulations

The European Commission has proposed an amendment to the Medical Devices Regulation (MDR) and to the In Vitro Diagnostic Medical Devices Regulation (IVDR) in order to not only enhance safety and transparency but also giving more time to medical devices manufacturers to adapt to such regulations. The new proposal issued on 23 January aims to ensure availability of the medical devices and protect patient care by introducing the following three key changes:

Extension of the transition periods

Since many manufacturers are not sufficiently prepared to comply with the requirements of the IVDR for various causes and the capacity of notified bodies within the EU is limited, the proposal introduces extended deadlines for manufacturers and notified bodies to comply with the IVDR by giving them more time to complete, under certain conditions, the necessary conformity assessment procedures without lowering the requirements.

High-risk devices (that is, class D devices according to the IVDR) have until December 2027, devices with high individual and moderate public health risk (IVDR class C devices) until December 2028, and lower-risk devices (class B and A sterile devices) until December 2029. This should mitigate the shortage of IVDR at least in a short term period.

Accelerated EUDAMED implementation

The European Database on Medical Devices (EUDAMED) will contain information about all medical devices and IVDRs placed on the EU market and consists of six modules: agency registration; Unique Device Identification and product registration; bodies and certificates; clinical investigations and performance studies; post-market surveillance and vigilance; and market surveillance.

The first three modules are currently available on a voluntary basis, while the post-marketing surveillance and vigilance and market surveillance modules are expected to be completed in 2024. The clinical investigations and performance studies module is not expected to be completed until the third quarter of 2026.

The Commission has proposed a phased roll-out of EUDAMED to facilitate effective implementation of the MDR and IVDR and intends to make its use mandatory once the modules have been audited and declared functional. The Commission sustains that such measure is crucial for ensuring the availability of in vitro diagnostics, enhancing transparency in the medical devices sector and supporting patient care without imposing unnecessary burdens on manufacturers.

Mandatory prior notice for supply interruptions

At least six months in advance, manufacturers are required to notify competent authorities, distributors and healthcare providers, if they anticipate a disruption or discontinuation in the supply of in vitro diagnostics or medical devices.

This measure is intended to give healthcare systems more time to foresee and implement a replacement solution or mitigating measures to ensure patient safety.

Original source: Osborne Clarke. Published: 27 February 2024

EU: May 26 Deadline Approaches for Medical Device Regulation 2023/607

The first deadline for Regulation 2023/607 (amending the European Medical Devices Regulation (2017/745, MDR) is rapidly approaching. Manufacturers must have an application with a notified body designated for the MDR for the legacy (or substitute) devices by May 26, 2024, a quality management system and an agreement with said notified body by September 26, 2024. There must continue to be no significant changes in design and intended use, the MDCG guidance 2020-3 may be an asset here.

If the manufacturers of the legacy devices are compliant, the legacy devices benefit from the following extended deadlines, at which point the devices must be compliant with all aspects of the MDR, to continue to be placed on the market.

  • December 31, 2027, for all class III devices, class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
  • December 31, 2028, for class IIb devices (non implantable), class IIa devices, and for class I
    Sterile/Measurement/Reusable surgical instrument.

Original source: EMERGO by UL. Published: 31 January 2024

The EU AI Act: How Will It Impact Medical Device Manufacturers?

On February 2, European Union Member States endorsed the world’s first comprehensive legal framework regulating artificial intelligence in the EU. The EU’s Artificial Intelligence Act (AI Act) applies across industries—from medical device manufacturers to consumer app developers—to both the AI systems themselves and the output produced by those devices.

Once the European Parliament and European Commission formally adopt the AI Act, which is expected this spring, developers of medical devices with AI-based products and components will have an additional set of requirements to meet. The requirements for AI systems will augment what’s already required under the EU’s Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).

MDR has stressed the resources of medical device companies of all sizes due to notified body backlogs, more rigorous reporting requirements, and ambiguities in the regulations themselves. Requirements under the AI Act may create more of the same.

The Notified Body Burden

Notified bodies, that perform the conformity assessments required under MDR and IVDR, will soon have an additional set of regulations to monitor. And concerning the AI Act, that means reviewing data on sophisticated technology that’s changing by the minute. With the AI Act,
notified bodies will likely have to find highly skilled experts to help with the requirements added as part of the conformity assessment for medical devices. This will lead to more delays and higher costs

AI Requirements for Medical Devices

Providers of high-risk AI systems (that includes all regulated medical devices with AI-based components or systems) must comply with several obligations. Many of them will sound familiar to anyone pursuing CE Marking under MDR.

Requirements under the AI Act include

  • that consists of a “continuous, iterative process that is planned and run throughout the entire lifecycle of a high-risk AI system.”
  • Conduct data governance, ensuring that training, validation, and testing datasets are relevant, sufficiently representative, and, to the best extent possible, complete, and free of errors.
  • Draft technical documentation that demonstrates compliance and provides authorities with information to assess that compliance.
  • Design the system so it automatically records events relevant for identifying national-level risks and substantial modifications throughout the system’s lifecycle.
  • Provide instructions for use to downstream deployers to facilitate compliance.
  • Design the system so that deployers can implement human oversight.
  • Design the system with appropriate levels of accuracy, robustness, and cybersecurity.
  • Establish a quality management system to ensure compliance.

The intent is for the AI Act to “harmonize” with MDR and IVDR. According to the current legal text, the application of regulations should be simultaneous and complimentary, with at least a little flexibility on how to meet the applicable requirements of both.

Concessions for Small and Midsize Businesses

Given the additional requirements will likely disproportionately affect small- and medium-size medical technology companies as much, if not more, than MDR, the European Commission has proposed several provisions intended to remove barriers for these companies. Those provisions include priority access to forthcoming “regulatory sandboxes,” which are physical, digital, or hybrid environments set up in member states where companies can develop and test technology with regulatory oversight.

The AI Act also requests that member states support smaller entities and start-ups with compliance-related education and information. The Act states European Digital Innovation Hubs should provide further technical and scientific support. The AI Act further suggests that notified bodies ease conformity assessment fees and translation costs for smaller entities, as well as allow “microenterprises” to establish quality management systems. It doesn’t specify whether simplified simplified versions must conform to ISO standards.

Conflicting Terms and Definitions

Another concern raised by multiple organizations relates to conflicting definitions and duplicative requirements. An earlier iteration of the AI Act was criticized for its overly broad definition of “artificial intelligence system.” MedTech Europe states that the definition has since been updated
to align with the definition given by the Organization for Economic Cooperation and Development (OECD). van Oirschot said verbiage that captures the range of systems that pose risks to human health, safety, and fundamental rights would be of value.

The agency may also need to clarify some misalignment between the AI Act, MDR, and GDPR. Carrillo points out that the AI Act requires the use of demographic data (eg, patient data) for training and validation of AI systems without factoring in GDPR requirements around healthcare data privacy and transparency. The AI Act does appear to include an exception for debiasing AI
systems, however.

And given the massive datasets needed to adequately train and validate an AI-based tool, it’s difficult to know when training is “complete” in the eyes of the Act. This aspect of AI-enabled device development could impact medical technology more so than other industries, given
the sensitive nature of the data needed to train and validate AI-based medical technology.

Original source: Mddionline. Published: 27 February 2024.

New MDCG Guidance Issued Concerning the Clinical Investigation Plan Investigations of Medical Devices for Clinical

The MDCG have published a guidance document on preparing the clinical investigation plan, in accordance with Section 3 of Chapter II of Annex XV of the MDR as well as the international standard ISO 14155:2020. The former is the legally required content of the Clinical Investigation Plan while the latter addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations. MDCG 2024-3 is meant to support sponsors developing their CIP by describing in greater detail what type of information is expected in the plan. The guidance also includes a clinical investigation plan synopsis template in Annex I.

Original source: Advena.mt. Published: 12 March 2024

EU Update: Overview of European Language Requirements for Medical Devices

To help medical device and IVD manufacturers understand the national language requirements under the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR), the European Commission recently published two tables on it’s website (January 17) with links for the relevant legal provisions for each member state.

The MDR and IVDR contain regulatory requirements for manufacturers to translate certain documentation into the official European Union language(s) (determined by the member state(s) in which the device is sold:

  • Accompanying information (Ref MDR Art. 10(11) and Annex I, section 23; IVDR Art. 10(10) and Annex I, section 20)
  • Implant Card (Ref MDR Art. 18(1))
  • Declaration of Conformity (Ref MDR Art. 19(1); IVDR Art. 17(1)
  • Field Safety Notice (Ref MDR Art. 89(8); IVDR Art. 84(8))
  • Documents for conformity assessment (Ref MDR Art. 52(12); IVDR Art. 48(12))

In addition to outlining the language requirements, the guidance also provides language requirements, if applicable, to the graphic user interface (GUI). While the Regulations do not specifically impose language requirements on the GUI, several member states have national legislation about GUIs.

The Regulations allow each member state to determine the official language(s) they will require for certain documentation. The published Overview of language requirements for manufacturers of medical devices provides manufacturers with a single resource that can be used without having to identify each member state’s requirements.

Original source: EMERGO by UL. Published: 18 January 2024.

Guidance Documents Issues By the Medical Device Coordination Group (MDCG)

MDCG has issued guidance documents over the past three months, see below. The European Commission published several updated Device Specific Vigilance Guidance (DSVG) documents on January 30. The newly released guidance documents cover four of the original five specific devices to which the now-obsolete MEDDEV DSVGs once applied: cardiac ablation, coronary stents, cardiac implantable electronic devices and breast implants.

January 2024
MDCG 2024-1: Device Specific Vigilance Guidance (DSVG) Template
MDCG 2024-1-1: DSVG 01 on Cardiac ablation
MDCG 2024-1-2: DSVG 02 on Coronary stents
MDCG 2024-1-3: DSVG 03 on Cardiac implantable electronic devices (CIEDs)
MDCG 2024-1-4: DSVG 04 on Breast implants
MDR/IVDR Language requirements: Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country

February 2024
MDCG 2024-2: Procedures for the updates of the EMDN

March 2024
MDCG 2024-3: Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices
MDCG 2024-3 Appendix A: Clinical Investigation Plan Synopsis Template

FDA’s CDRH Announces Intent to Initiate the Reclassification Process for Most High Risk IVDs

As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for most IVDs that are currently class III (high risk) into class II (moderate risk). The majority of these tests are infectious disease and companion diagnostic Reclassification would manufacturers IVDs. allow of certain types of tests to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than the premarket approval pathway, the most stringent type of FDA medical device review.

Notably, CDRH would still be conducting a premarket review of reclassified tests under the 510(k) pathway. Such reclassifications may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests.

CDRH intends to propose reclassification of devices for which we believe there is sufficient information to establish special controls that, together with general controls, provide a reasonable assurance of safety and effectiveness for these tests.

In addition to the reclassification process, would continue taking a risk-based approach in the initial classification of individual in vitro diagnostic devices to determine the appropriate level of regulatory controls and whether a new test may be classified into class II through De novo classification (and special controls established), rather than being Class III and subject to the PMA pathway. Based on our experience, we believe that special controls could be developed, along with general controls, that could provide a reasonable assurance of safety and effectiveness for most future companion diagnostic and infectious disease IVDs. As such they would be regulated
as class II devices.

Original source: US FDA official website. Published: 31 January 2024.

US FDA Incorporates ISO 13485 within Its QMSR Final Rule

The US Food and Drug Administration (FDA) has issued a final rule that will recognize the ISO 13485 international medical device quality management standard as part the agency’s Quality Management System Regulation (QMSR), a major step toward greater harmonization of medical device regulations in the US with those of other markets and jurisdictions around the world.

Issued by the FDA on February 2, the QMSR Final Rule incorporating ISO 13485 becomes effective on February 2, 2026. The final rule follows a proposed rule from the agency in early 2022 targeting greater alignment between FDA’s erstwhile Quality System Regulation (QSR) and
ISO 13485.

Manufacturers have two years to align internal processes and procedures, make appropriate changes within their organizations and update their documentation according to QMSR requirements.

Where possible, the FDA has accepted the incorporated ISO 13485 requirement without modification. However, the FDA confirms that compliance only with ISO 13485 does not fully satisfy the QMSR. FDA has added “limited” additional requirements to the QMSR where appropriate, and thus manufacturers must meet those additional QMSR requirements as well as to those set forth in ISO 13485. Some examples of these additional requirements include:

  • Requirements for control of records, especially around certain records that interface with other requirements in the FD&C Act such as records of complaints and servicing activities required by part 803, Medical Device Reporting and UDI in accordance with part 830, Unique Device Identification (specified in § 820.35 of the final rule);
  • Requirements related to labelling and packaging – FDA believes that ISO 13485 does not specifically address the inspection of labeling by the manufacturer, which is why FDA is retaining in this final rule requirements from the QMSR that strengthen controls for labeling and packaging operations.

Original source: EMERGO by UL. Published: 5 February 2024.

TGA Seeks To Clarify Rules on CDSS Software

TGA is seeking feedback on proposed clarifications of its position on the regulation of clinical decision support system (CDSS) software. The agency introduced clarifications to the Therapeutic Goods (Medical Devices) Regulations 2002 for software-based medical devices in 2021 to address a government request for improvements to the regulation of digital products. Since then, industry representatives and other people have raised questions and sought further clarification about CDSS and how they are regulated in Australia.

TGA has responded with a consultation document that outlines problems related to the use of the term “clinical decision support” by device suppliers, the incorrect application of the conditional exemption to IVD software and issues assessing the performance of CDSS software.
The agency has proposed four actions to address the problems. TGA is seeking feedback on whether to introduce a definition of CDSS, clarify the scope of a regulatory exemption, require software to provide the reasons behind its recommendations and change its guidance materials.

The consultation closes on 6 May.

Original source: RAPS. Published: 18 March 2024.

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References
Image 1: Medical device testing
Image 2: Pharmaphorum
Image 3: Europa commission
Image 4: tctmd