June 3, 2021 Regulatory Updates
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Medical Devices – Regulatory Updates- June Volume 1

EUROPE

1. Clinical investigation application/notification documents

The sponsor of a clinical investigation is required to submit an application/notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV of Regulation (EU) 2017/745 (MDR). The application/notification is required to be submitted by means of the electronic system referred to in Article 73 of the MDR.

In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to MDR. These documents include:

  • Clinical investigation – application/notification form under the MDR
  • Addendum to the clinical investigation application/notification form for: o Additional investigational device(s) (section 3) o Additional comparator device(s) (section 4) o Additional investigation site(s) (section 5)
  • Clinical investigation supporting documents – Appendix of documents to attach
  • Checklist of general safety and performance requirements, Standards, common specifications and scientific advice.

Insofar as possible, the clinical investigation application/notification form includes same data fields to the EUDAMED system in development.

For further guidance with respect to the application of certain MDR provisions during the absence of EUDAMED please see MDCG 2021-1 Rev.1. In the absence of EUDAMED, the Union-wide unique single identification number for a clinical investigation, which shall be used for all relevant communication in relation to that clinical investigation will be the CIV-ID which is currently used for Eudamed2, the electronic system which supports the medical device Directives.

https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-8_en.pdf

2. Commission Statement on the decision by the Swiss Federal Council to terminate the negotiations of the EU-Swiss Institutional Framework Agreement

On 26 May 2021, the Federal Council took the decision to terminate the negotiations of the EU-Swiss Institutional Framework Agreement. We take note of this unilateral decision of the Swiss Government. The Federal council said that they regret this decision, given the progress that has been made over the last years to make the Institutional Framework Agreement a reality.

The EU-Swiss Institutional Framework Agreement was intended as the foundation to enhance and develop EU-Swiss bilateral relations for the future. Its core purpose was to ensure that anyone operating in the EU Single Market, to which Switzerland has significant access, faces the same conditions. That is fundamentally a matter of fairness and legal certainty. Privileged access to the Single Market must mean abiding by the same rules and obligations. This is why, back in 2019, the EU insisted that this agreement was so essential for the conclusion of possible future agreements regarding Swiss further participation to the Single Market, and also an essential element for deciding upon further progress towards mutually beneficial market access.

This agreement would have allowed for a consolidation of the bilateral approach and ensured its sustainability and further development. Without this agreement, this modernization of our relationship will not be possible and our bilateral agreements will inevitably age: 50 years have passed since the entry into force of the Free Trade Agreement, 20 years since the bilateral I and II agreements. Already today, they are not up to speed for what the EU and Swiss relationship should and could be. We will now analyze carefully the impact of this announcement.

3. NOTICE TO STAKEHOLDERS: STATUS OF THE EU-SWITZERLAND MUTUAL RECOGNITION AGREEMENT (MRA) FOR MEDICAL DEVICES

The new Medical Devices Regulation (EU) 2017/745 becomes fully applicable on 26 May 2021, this new Medical Devices Regulation is not included, in its relevant parts, in the medical devices chapter of the MRA.

The MRA is one of the key agreements between the EU and Switzerland, facilitating bilateral trade in a number of key sectors such as machinery, motor vehicles and medical devices. It is essentially a “single market access” and “dynamic alignment” with EU rules agreement, two principles which are also at the core of the Institutional Framework Agreement in negotiation with Switzerland since 2014. The MRA falls under the scope of the EU-Switzerland Institutional Framework Agreement. This is fundamentally a level playing field issue.

As a result, until a potential agreement on the proposed modification to the MRA is reached, the trade facilitating effects of the MRA for medical devices falling under the new Medical Devices Regulation, including the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations, cease to apply as from 26 May 2021.

The following consequences as of 26 May 2021 should therefore be noted by stakeholders:

  • For all new devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place their devices on the EU market. In particular, new Swiss medium and high-risk devices must be certified by conformity assessment bodies established within the EU.
  • Existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU.
  • For existing certificates issued under the MRA by conformity assessment bodies established in the EU, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland, must designate an authorised representative established in the EU.
  • On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Ordinance on Medical Devices establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.
  • To address the consequences set out in this notice, market participants (e.g. affected manufacturers, EU importers and distributors, authorised representatives) as well as EU market surveillance and customs authorities in Member States are required to act in accordance with the Medical Devices Regulation (EU) 2017/745:
  • Since existing certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU as of 26 May 2021, to ensure that medical devices are certified by an EU conformity assessment body where such certification is required on the basis of the applicable conformity assessment procedure;
  • to ensure compliance with the requirements for economic operators, in particular the need for an EU authorised representative;
  • to comply with the requirements on registration and labelling of products.

4. Questions & Answers: Application of Regulation on Medical Devices – EU rules to ensure safety of medical devices

Following Questions are answered as follows:

  • Why do we need new rules on medical devices?
  • What are the main benefits for patients?
  • Which products are affected by the new regulation?
  • Will the new rules be able to keep up with future progress?
  • Will medical devices that were certified under the old rules have to reapply?
  • How will the new Regulation make medical devices safer?
  • What will be the role of Notified Bodies?
  • How will the scrutiny mechanism for assessment of high-risk devices work?
  • What are the rules on reprocessing single-use devices?
  • What are the rules for products without an intended medical purpose listed in Annex XVI of the Medical Devices Regulation?
  • Does the regulation address the use of nanomaterials in medical devices?
  • What is the state of play on the medical devices database, EUDAMED?
  • Why was the application of the Medical Devices Regulation postponed by a year?

5. MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers

In light of the MDR 2017/745 UDI requirements, and considering that:

  • for contact lenses, a specific UDI assignment solution is under development by the MDCG UDI WG, which may also be extended to spectacle frames and
  • for spectacle lenses and ready readers, whilst a specific UDI assignment solution is agreed, 1 its practical application is yet to be formalised the following clarifications should be observed in terms of UDI assignment, carrier labelling and registration.

UDI Assignment: the abovementioned products are expected to be in compliance with the UDI assignment obligations set out in Art 27(3) and Art 29 (1) MDR, applying mandatorily from 26 May 2021, until specific UDI assignment solutions are finalised.

UDI Carrier labelling: for Implantable devices and Class III devices, Class IIa/IIb devices and Class I devices, UDI labelling requirements apply from May 2021, May 2023, and May 2025 respectively. As the majority of the aforementioned products are Class IIa/IIb devices and Class I devices, it is expected that there will be sufficient time to reflect the specific UDI assignment solutions on the label.

UDI & Device Registration: registration of devices starts to apply 24 months after the date of publication of the notice referred to in Article 34(3) MDR. Before this time, or until specific UDI assignment solutions are finalised, manufacturers of the above mentioned products are instructed not to use on a voluntary basis, the UDI/Device registration module of EUDAMED, to register devices and UDI related information as established in Part A and B of Annex VI MDR.

US FDA

6. Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

As described below, FDA does not intend to object to the use of legacy FDA identification numbers on device labels and packages for finished devices manufactured and labeled prior to September 24, 2023. In addition, this guidance addresses requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs).

Under FDA’s 2013 unique device identification (UDI) final rule, medical device labels and packages are required to bear a UDI according to the schedule set in the final rule, with some exceptions and alternatives for certain devices. The UDI Rule also includes a provision to rescind National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers assigned to devices once UDI provisions are applicable to them.

In a newly issued immediately effective guidance that supersedes the agency’s 2016 enforcement policy, FDA said it will not object to the use of NDC and NHRIC numbers on device labels and device packages for finished devices that are manufactured and labeled prior to 24 September 2023.

“Removal of [NDCs] from medical device labels, which is required to occur beginning September 2021 pursuant to the [UDI] Rule, will significantly disrupt patient access to critical medical products and jeopardize public health. This includes the millions of Americans with diabetes who rely on the NDC for the processing and dispensing of devices used to manage diabetes, which include, for example, glucose sensors, strips, monitors, meters, syringes, lancets, and insulin pumps,” AdvaMed wrote in its comments. AdvaMed and other commentors also cited the COVID-19 pandemic as an ongoing source of disruption to many of the players involved in the switch from legacy identifiers to UDI.

FDA further explains that because more devices will require UDIs by September 2024, it anticipates that healthcare systems and supply chains will be more equipped to rely on UDIs by that time.

7. Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations

This guidance document provides recommendations for nonclinical testing and study design considerations for Investigational Device Exemptions (IDEs) feasibility and pivotal clinical studies for implanted Brain-Computer Interface (BCI) devices for patients with paralysis or amputation. The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life.

For the purposes of this guidance document, implanted BCI devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation.

8. Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

This guidance document provides recommendations for 510(k) submissions for peripheral vascular atherectomy devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular atherectomy submissions.

9. Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

This guidance document provides Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.

10. CDRH seeks feedback on proposed materials labeling framework

On May 20, 2021, the FDA published a discussion paper, Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework, intended to stimulate discussion and to solicit feedback from a variety of stakeholders on how materials information could be communicated. The discussion paper highlights considerations for labeling of medical devices as it relates to material composition of the device.

Submit Comments: The FDA is accepting feedback through a public docket on the Federal Register: FDA-2021-N-0334. The last day to submit comments to the docket is July 19, 2021.

CANADA (HC)

11. Medical Device reports and publications

The Medical Devices Performance Reports provide detailed metrics about the timeliness of pre-market medical devices review process against the performance service standards. The report compares five quarters, and the report is broken down by Parts of the Regulations and the applications types covered by them. Within the report, statistics are provided by submission type and show the number received, the number licensed the number in workload, the number of decisions and time to first decision against Cost Recovery service standards.

Applications Received are counts of submissions received during the Quarter using the filing date (AC date) which is the date the submission is considered received by Health Canada. Workload is the number of submissions “in process” on a given day. Backlog is the proportion of the workload that is over target Often the term workload is used to mean the amount of work received over a period of time and is a common source of confusion. Licences issued are a count of applications licenced after completion of scientific review. Decisions are points in the process where an action is recommended to license, reject, refuse, or request additional information, in regards to the application. First decision is measured from acceptance for review to the issuance of a licence or a request for further information (AI). Second decisions are measured from receipt of a response to an AI to a decision to license or issuance of a subsequent AI.

Quarterly Reports: To obtain a full electronic copy of the Medical Devices Directorate Performance Quarterly Reports, please contact publications@hc-sc.gc.ca.

For more information regarding the reports please contact Medical Devices Directorate (hc.meddevices-instrumentsmed.sc@canada.ca).

12. Medical Devices Action Plan: Progress report

Medical Device Action Plan (MDAP) purpose and progress
We launched the MDAP in December 2018. Since its publication, we have made significant progress toward achieving the goals of the action plan’s 3 pillars. While we focused on the COVID-19 pandemic in 2020, we have continued to move forward and incorporate the action plan’s principles into our work.

In 2020, we approved or authorised:

  • 545 COVID-19 medical devices and 18 clinical trials for medical devices related to COVID-19
  • 332 new medical devices in the highest risk categories (Classes III and IV)
  • 122 new investigational testing applications for medical devices
  • 2,693 requests for special access to medical devices

We also created a stand-alone Medical Devices Directorate (MDD) in January 2020. This new directorate represents an innovation for Health Canada in that we have, for the first time, incorporated both pre-market work and post-market work within the same directorate. We did this in recognition of the fast pace of medical device development and the importance of regulating medical devices from a life cycle perspective. The creation of this new directorate will allow us to engage more effectively with patients, healthcare professionals and industry.

PART I – Improve the safety and effectiveness of medical devices and how they get to the Canadian market
Under this pillar, we are working to:

  • increase research by medical professionals and increase patient protection
  • review evidence requirements and expand scientific expertise

https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/medical-devices-action-plan-progress-report.html

AUSTRALIA (TGA)

13. Therapeutic Goods (Medical Devices-Application Form for Inclusion) Approval 2021

Update to legislative instrument

  • Name
  • Commencement
  • Authority
  • Definitions
  • Approved forms – medical devices other than IVD medical devices
  • Approved forms – IVD medical devices
  • Repeals

14. Guidance for Declaration of Conformity: For Class I non-sterile non-measuring, Class 1 in vitro diagnostic (IVD) medical devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)

This document is designed to assist manufacturers in completing the relevant Declaration of Conformity and to assist sponsors confirming that documentation prepared by the manufacturer is complete.

Sponsors must obtain a Declaration of Conformity from the manufacturer to upload as part of their application for inclusion in the ARTG of a Class I non-sterile, non-measuring medical devices, Class 1 IVD devices, Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only), and Class I Systems and Procedure Packs. This guidance is not legislative in nature and is subject to the requirements of therapeutic goods legislation. The Therapeutic Goods Administration (TGA) will continue to update this guidance as required.

15. Including IVD medical devices in the ARTG

The ARTG is a register of therapeutic goods accepted for importation into Australia, supply for use in Australia, or exportation from Australia. The ARTG can be viewed from the TGA eBusiness Services (eBS) website.

Medical devices1 cannot generally be imported, supplied in or exported from Australia unless they are included in the ARTG.

Exceptions to this requirement include devices that are supplied through one of the following mechanisms for supplying medical devices in Australia not included in the ARTG:

  • Clinical Trials in Australia
  • Authorised Prescribers
  • Special Access Scheme
  • Personal Importation
  • Exemptions in the national interest, to deal with emergencies

Philippines (FDA)

16. Philippine FDA starts consultation on post-market surveillance requirements

The Philippine Food and Drug Administration (FDA) has begun a consultation about the postmarket surveillance of new drugs under monitored release. FDA wants to change its policies in response to new technologies and to harmonize its requirements with those of other countries.
Manufacturers of new drugs cleared for use under monitored release in the Philippines must fulfill postmarket research requirements for three years to gain a regular registration. The FDA policy dates back to 1987. Last year, FDA released guidance on the pharmacovigilance requirements for all drugs, leading it to re-evaluate its approach to the monitored release of new drugs.
The draft guidelines set out the postmarket surveillance requirements for new drugs classified as monitored release. Applicants need to submit a risk management plan that complies with the 2020 pharmacovigilance guidance and discusses plans to further characterize the safety concerns.
FDA will evaluate applications that are already pending but lack a local Phase IV study protocol using its new guidance. FDA will issue a postapproval letter if additional local pharmacovigilance activities are needed but the applicant met all the requirements.

JAPAN (PMDA)

17. PMDA sets out plan for accelerating medical devices access

Japan’s PMDA has already shortened medical device review times. In fiscal 2019, PMDA typically took 11.1 months to review normal devices and 7.3 months for priority candidates, beating its respective targets of 14 months and 10 months. PMDA chief executive Fujiwara Yasuhiro said the data show “the device lag that had previously been a problem in Japan” is now a thing of the past. PMDA now is trying to accelerate access to specific groups of products. Yasuhiro highlighted four specific initiatives.

A breakthrough device program, called Sakigake, provides priority access to PMDA, enhanced pre-submission consultation, and accelerated review to devices that impress in early-phase clinical trials. PMDA has set a six-month target review timeframe for Sakigake devices.

Yasuhiro also highlighted as other examples of how PMDA is supporting development regulatory privileges for devices designed for use in children and a conditional early approval system. The conditional approval system is intended to enable access to devices that address significant unmet needs but are hard to study in conventional confirmatory clinical trials.

Finally, PMDA’s IDATEN initiative caters to the emergence of medical devices that continue to change after coming to market, such as products based on artificial intelligence. When reviewing such devices, PMDA will confirm change plans so that the authorization holder can quickly make certain partial amendments to their approvals.

18. PMDA shares guidance on the use of registry data in applications

PMDA has published English-language versions of two recent documents on the use of registry data in applications involving drugs, medical devices and regenerative medical products in Japan.
One document sets out basic principles for the use of registry data and the second document focuses on the reliability of registry data.

1.    Purpose of the points to consider

This notification indicates the points to consider for ensuring the reliability in utilization of data from the registries (hereinafter referred to as “registry data “) when the applicant (including sponsor and sponsor-investigator; the same shall apply hereinafter) intends to utilize registry data as a clinical data (evaluation data) in the data/documents to be submitted for the following applications of drugs, medical devices, and regenerative medical products (hereinafter referred to as “Application data/documents”),

  • Application for marketing approval
  • Application for re-examination
  • Application for interim evaluation
  • Application for use-results evaluation
  • Application for re-evaluation
  • Application after conditional and time-limited approval

2.    Concepts of ensuring the reliability

A registry is constructed for the purpose of conducting studies related to the followings:

  • the specific disease
  • the use of drugs, medical devices, and regenerative medical products, etc.
  • the populations defined by specific conditions (e.g., age, pregnant women, characteristics of specific patients)

Since registry data is collected according to the original purpose of registries, the concepts and methods adopted to ensure reliability of registry data vary. Also, in the case of secondary utilization of registry data as Application data/documents., etc., the level of reliability required for the registry data may vary depending on the purpose of utilization (refer to “Basic Principles on Utilization”). Therefore, an applicant is not required to ensure all the matters provided in this notification in a unified manner. But an applicant is required to consider necessary matters on case by case basis according to the purpose of utilization. Consequently, in the case of utilization of registry data as Application data/documents, etc., an applicant is encouraged to consult Pharmaceuticals and Medical Devices Agency (hereinafter referred to as “PMDA”) regarding necessary matters, etc. to ensure the reliability of registry data in Application data/documents., etc.

3. Concepts of ensuring the reliability in utilization of registry data as Application data/documents for marketing approval

The following matters are specified for an applicant to utilize registry data as Application data/documents for marketing approval.

  • Compliance matters for applicants utilizing registry data
  • Points to consider for registry data utilized for application data/documents

This notification should also be referred to when an applicant intends to utilize registry data for Post-marketing clinical studies in the applications for reexamination/use-results evaluation, etc

Sri Lanka (NMRA)

19. Notices for Medical Devices

  • Extension of validity period of Registration certificates & licenses upto 30th June 2021
  • Extension of validity period of Manufacturing licences, Registration certificates, and GMP certificates of local manufacturers
  • Extension of the validity period of certificates of registration and license issued by the NMRA and import of products which less than 75% shelf life
  • Restriction for issuing Waiver of Registration (WORs) with effect from 26th June 2020
  • Extension of validity period of Manufacturing licences, Registration certificates, and GMP certificates of local manufacturers
  • NMRA approvals to Face masks, PCR Test kits, PPE kits & Thermometers.
  • NMRA expedited review of COVID-19 diagnostic test kits in Sri Lanka
  • NMRA approvals relevant to DHS tenders
  • Extension of validity of Certificates of Registration and Import licences due to prevailing situation
  • For information on the import & manufacture of Medicine, Surgical masks, Test kits, & Thermometers
  • Laboratory testing for COVID 19
  • Falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19.

Singapore (HSA)

20. Consultation for Guidance on the Medical Device Unique Device Identification (UDI) System

The Medical Devices Branch (MDB) has published a draft document “Guidance on the Medical Device Unique Device Identification (UDI) System” for comments. This document is intended to provide clarity on the regulatory requirements for Unique Device Identification (UDI) implementation in Singapore and the details on the steps to submit UDI information into the Singapore Medical Device Register (SMDR) and Class A Medical Device Database. We would like to invite our stakeholders to provide feedback on this document:

The Consultation period for this document is from 25 May 2021 to 30 June 2021. Please submit your feedback using the prescribed guidance feedback form via our online UDI enquiry form by 30 June 2021. Please indicate “Guidance on the Medical Device UDI System” in Question 6 of the form.

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