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Medical Devices - Regulatory Updates - August Volume 1

Medical Devices - Regulatory Updates - August Volume 1

August 04, 2020 Regulatory Updates

EUROPE

1.

Fact sheet on MDR requirements for Transparency and Public Information

The European Commission has published an overview of the information that will be publicly available under EP and Council Regulation (EU) 2017/745 on medical devices. This is mainly information published in the EUDAMED database, but also data published through other information sources by the European Commission, national competent authorities, industry and notified bodies. A document summarizing the above is available in provided link.

Transparency is a key objective of the Medical Devices Regulation (MDR) aiming at providing a large access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market.

The transparency requirements under the MDR can be divided in different categories:

  • Information on medical devices made accessible to the public in Eudamed.
  • Information which is pro-actively made publicly available outside Eudamed by the Commission, the national competent authorities, the industry or the notified bodies.

2.

MHRA: Medical Device "Certificates of Compliance" / "Attestation of Conformity" have no legal standing under UK Medical Device Regulations 2002

Certificates of compliance or Attestation of Conformity documents are not evidence that the manufacturer of the device has met the requirements of the UK Medical Device Regulations 2002, nor are they CE Certificates issued under Directive 93/42/EEC.

The certification body may have issued the certificate or attestation following a review of the technical documentation for the medical device concerned. However, this is not a regulatory requirement and so the certificate issued has no regulatory validity.

Valid CE certificates will be issued by one of the organizations listed and will have been issued from within the EU.

3.

MDCG posts CEAR template

The Commission's Medical Devices Coordination Group (MDCG) released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medical devices undergoing conformity assessments.

This template applies to MDR Annexes IX section 4 and Annex X section 3. It also applies to assessments of technical documentations on a sampling basis for class IIa/IIb devices in accordance with Annex IX sections 2.3 and 3.5 and Section 10 of Annex XI(A).Aspects related to the clinical evaluation assessment are also laid down in Section 4.5.5 and other relevant sections of Annex VII. It also applies to medical devices for which clinical data is not deemed appropriate to demonstrate conformity with Annex I, and the demonstration of an adequate justification for this.

US FDA

4.

FDA Published New Guideline “Multiple Function Device Products: Policy and Considerations”

Products with at least one device functionand at least one “other function” (see Section III) are referredtoin this guidanceas “multiple function device products.”For purposes of this guidance,for any given product, the term “function” is a distinct purpose of the product, which could be the intended use or a subsetof theintended use of the product.This guidance explains FDA’s regulatory approachand policyforall multiple function device products.Specifically, this guidance clarifies when and how FDA intends to assess the impact of “other functions” that are not the subject of a premarket review on the safety and effectiveness of advice function that is subject to FDA review.

5.

Medical Device Exemptions 510(k) and GMP Requirements

The Food and Drug Administration (FDA or the Agency) is publishing an order setting forth the Agency's final determination to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the list of class II devices. The exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the list of class II devices to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

6.

FDA Announced Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting on Sept. 8-9, 2020

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

7.

An unpublished Notice by the Food and Drug Administration on 08/03/2020 for Medical Device User Fee Rates for Fiscal Year 2021

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2021, which applies from October 1, 2020, through September 30, 2021. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2021, you should not submit a Small Business Certification Request. This document provides information on how the fees for FY. This document is scheduled to be published in the Federal Register on 08/03/2020 and available online at federalregister.gov/d/2020-16793, and on govinfo.gov 2021 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

Australia (TGA)

8.

3-D printing (additive manufacturing) of medical devices

Information for manufacturers to assist them with addressing risks and meeting the Australian regulatory requirements for medical devices has been released.

9.

Delays to the commencement of certain medical device regulatory changes

The Australian Medical Device Regulations have been amended to delay implementation of the reforms from 25 August 2020 to:

25 November 2021 for reclassification of certain devices, including

  • spinal implantable medical devices
  • active implantable medical devices
  • medical devices that administer medicines or biologicals by inhalation
  • medical devices that are substances (or combinations of substances) for introduction into the body
  • active medical devices for therapy that include a diagnostic function to significantly determine patient management, and
  • medical devices that are intended to be used in direct contact with the heart, the central circulatory system or the central nervous system

25 February 2021 for medical device software

25 February 2021 for personalised medical devices (including 3D printed devices) and

25 February 2021 for systems or procedure packs.

It is important to note that the delay to the commencement of the reforms does not change the end of the transition period. This remains at 31 October 2024. This means there is now less time to transition to the new arrangement for these devices.

10.

TGA plans changes to assistive technology oversight

Australia’s Therapeutic Goods Administration (TGA) is set to limit its definition of assistive technology to low-risk products to clarify which devices are subject to its oversight.

Singapore (HAS)

11.

HSA safety communication: Update on SWEYNTOOH cyber security Vulnerabilities Affecting Certain Bluetooth Enabled Medical devices

The Health Sciences Authority (HSA) is providing an update to safety communication published on 6 March 2020 regarding “SWEYNTOOTH” cyber security vulnerabilities.

The SUTD research team has recently discovered four new SWEYNTOOTH vulnerabilities which could potentially affect more medical devices.