Medical Devices – Europe, Asia and ROW Regulatory News – Feb. 2024

EUROPE

Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices

The Commission, after consulting the Member States in the Medical Device Coordination Group, is considering launching a second call to cover the remaining categories of class D devices:

1. Arboviruses
2. Haemorrhagic fever and other biosafety level 4 viruses
3. Parasites
4. Blood grouping

EU reference laboratories in the field of IVDs are designated to perform important tasks outlined in Article 100 of Regulation (EU) 2017/746. EURLs verify the performance of class D devices and compliance with common specifications and they perform batch testing of class D devices in response to requests by notified bodies.

EU reference laboratories form a network to coordinate and harmonise their working methods regarding testing and assessments.

MDCG 2024-1 – Device Specific Vigilance Guidance (DSVG) Template

The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices.

It provides further clarification for vigilance reporting of Specific Devices to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) [1] and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) [2]. This DSVG does not replace or extend any of those requirements.

The document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR and in Article 2(67) and (68) IVDR, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with Specific Devices to the relevant Competent Authority.

MDCG 2024-2 – Procedures for the updates of the European Medical Device Nomenclature

The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 – In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users

The document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.

• Actors involved
• Procedure for the annual revision of the EMDN
• Pilot procedure for the ad-hoc updates of the EMDN requiring an expedited review

Commission tracks 35% increase in MDR applications, reduction in missing documents

The number of applications for certification under the Medical Device Regulation (MDR) increased 35% between June and October last year, according to survey data collected by the European Commission.

The Commission also presented data on the In Vitro Diagnostic Regulation (IVDR). The number of IVDR applications and certificates rose 30% and 40%, respectively, from June to October. The number of filings and certificates for Class D devices, the products with the near-term deadline that informed plans to extend the timeline, hit 336 and 119, respectively, in October.

AUSTRALIA

Update: Guidance on Medical device labelling obligations

The guidance explains how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.

 Essential Principle 13 of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002- external site (the Regulations) This outlines the requirements for labelling and instructions for use.

Manufacturer obligations

Medical device manufacturers need evidence that they follow the Essential Principles. This including those that relate to labelling and instructions for use.

Clause 13.3 in the Regulations lists all information that must be provided with a medical device. The manufacturer should ensure that all information is in English.

Sponsor obligations

Under Regulation 10.2, sponsors name and address must be all devices they supply within Australia.

This information should be:

• in a manner that allows the sponsor to be readily identified by a user of the device; and
• in a way that is appropriate for the device under Essential Principle 13.2.

Guidance on Regulation of menstrual cups in Australia

The guidance gives a brief outline of the regulatory requirements stated in Therapeutic Goods

Order No.99 – Standards for Menstrual Cups.

Update on Vapes: information for prescribers

Vapes include vaping substances, vaping accessories and vaping devices.

From 1 January 2024, the importation of all disposable vapes is banned. This means that patients cannot purchase any disposable vapes online from overseas, even if they have a prescription.

From 1 March 2024, the personal importation of all vaping substances and reusable vaping devices will be banned. This means that consumers will no longer be able to order vapes (including therapeutic vapes) from overseas, even if they have a prescription.

currently three main pathways through which the person will be able to access the product on your prescription:

• Authorised Prescriber (AP) Scheme
• Special Access Scheme (SAS)
• Personal Importation Scheme (this pathway ceased on 1 January 2024 for disposable therapeutic vapes and will cease on 1 March 2024 for reusable therapeutic vapes).

BRAZIL

Clarification: Anvisa clarifies the use of smartwatches to measure blood glucose levels

Anvisa published a technical note with its position on the use of a smartwatch (also known as a smart watch) to measure parameters such as blood glucose (blood sugar concentration) and oximetry (blood oxygen saturation).

A Technical Note 12/2024/SEI/GQUIP/GGTPS/DIRE3/ANVISA clarifies that any device that performs measurements recognized as typically for medical use must be regularized with the Agency. As an example: blood glucose measurements, oximetry, blood pressure, electrocardiogram and notification of irregular heart rhythm.

CHINA

Announcement of the State Food and Drug Administration, National Health Commission, and National Bureau of Disease Control and Prevention on the Issuance of Regulations on the Management of Emergency Use of Medical Devices (Trial) (2023 No. 150)

Medical devices intended for emergency use shall be medical devices for which similar products have not been registered in China, or although similar products have been registered, the product supply cannot meet the use needs of particularly major public health emergencies or other emergencies that seriously threaten public health.

The emergency medical devices referred to in this regulation do not include Class I medical devices.

CZECH REPUBLIC

English versions of information and guidelines for advertising medical devices and in vitro diagnostic medical devices

The Institute informs that it has published English versions of information and advisory guidelines on advertising of medical devices and in vitro diagnostic medical devices, which are available on the Dozor nad rekloum | NISZP.  

Assignment of power of attorney in the Information System of Medical Devices (ISZP)

If you want to assign a power of attorney (PM) to perform actions in the ISZP, you request its assignment electronically in the ISZP interface.

The condition for launching a request for PM approval is that the entities that will figure in the power of attorney process have an account in the external identities portal, through which you request access to ISZP and at the same time set up user accounts.

If the above conditions are met, then you can start a request for PM approval in ISZP . The course of the process depends on the way you log in to ISZP.

The procedure of manufacturers of custom-made products after the launch of ISZP

The announced activity of the manufacturer of the product to order will be migrated to ISZP from RZPRO with generic groups of GMDN nomenclature. With regard to § 73, paragraph 2 of Act No. 375/2022 Coll. The Institute migrates all data already reported by the manufacturer of the product to the ISZP. Pursuant to Section 8, Paragraph 4 of the same law, the manufacturer has the obligation to notify the Institute of his activity within 30 days of its commencement, as well as the list of generic groups of manufactured products within 6 months of the start of production and the end of this activity.

Following the migration of data, the Institute recommends that manufacturers of custom-made devices request access data to ISZP and check their data, or submit a change notification within a period of one year, by which they report the generic group according to the European Nomenclature of Medical Devices (EMDN). The EMDN number is uploaded directly to the ISZP in the notification guide.

Information to announce the activity of the ethics committee on medical devices and in vitro diagnostic medical devices

The system will make it possible to fulfill the obligation to notify the ethics commission of the healthcare service provider according to Act No. 375/2022 Coll. on medical devices and in vitro diagnostic medical devices (Law on Devices).

The institute warns that if the ethics commission is not announced in accordance with the law on resources in ISZP (after its launch), its approval will not be taken into account when requesting permission for clinical trials (KZ) and functional capacity studies (SFZ).

Information regarding the submission of ethics commission reports through the ISZP system will be published together with the launch of the ISZP.

HONG KONG

“Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)” has been added

The Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)(MD111) on this page are relevant to device(s) which had been procured by the Hospital Authority. When submitting a medical device listing application, the applicant should include the duly completed Supplementary Information Sheet along with the relevant listing application forms and required documents.

Applicants are also advised to take reference to documents issued under the Medical Device Administrative Control System when completing their medical device listing application.

IRELAND

EU4Health Programme IncreaseNET Joint Action

IncreaseNET Joint Action (JA) supports the increased capacity and competence building of the EU medicines regulatory network. IncreaseNET is co-funded by the EU4Health Programme and is coordinated by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) and brings together 29 partner organisations, mostly national competent authorities, from 27 EU / EEA countries and Ukraine.

This joint action will run from 1 January 2024 to 31 December 2026 and the total value of this three-year project is estimated at €10 million.

As part of IncreaseNET Joint Action, the HPRA has taken on the role of Leader of Work Package 5, Delivery of Training Materials. This is an exciting opportunity to be involved in the production of innovative learning resources, that will attempt to address the ever-evolving world of scientific development and regulation.

ITALY

Custom-made medical devices, the deadlines for registration in the new lists of manufacturers already registered have been extended

The new online service was activated starting from 25 September 2023, based on requests from some trade associations, which expressed the need for additional time to complete the transition to the new system, the date initially foreseen has been extended to May 1, 2024 .

After this date, therefore starting from 2 May 2024, the pre-existing lists relating to manufacturers of customized medical devices will no longer be available for consultation on the institutional website of the Ministry of Health.

Medical devices, obligations of distributors and importers

The MDCG 2021-27 guideline provides clarifications relating to the obligations for importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). In particular, the document sets out details on the operational and practical implementation of Articles 13 and 14 and other related obligations on importers and distributors.

LATVIA

The State Medicines Agency (ZVA) invite all distributors of medical devices to register in the LATMED database

The State Medicines Agency (ZVA) reminds that all distributors of medical devices must register in the LATMED database of the Medical Devices Register.

To register in the LATMED database, we invite all distributors of medical devices to submit a ZVA application by sending it to info@zva.gov.l and specifying the following information:

• company name (trader’s company);
• registration number;
• legal address;
• telephone number and electronic mail address;
• the name and legal address of the manufacturer(s) of the distributed medical devices;
• classification class(es) of common medical devices (please note that specific names of medical devices do not need to be specified).

MALAYSIA

Placement of HIV self-test (HIVST) kit in Malaysia market

The document is written to guide the establishment on both pre-market, placement on the market and post-market requirements including requirements on registration of HIVST, licensing of establishments dealing with HIVST, product labelling, advertising and distribution and post-market surveillance and vigilance activities.

Human immunodeficiency virus (HIV) is a retrovirus that targets immune system cells1 (mainly CD4-positive T-cells and macrophages), making an individual more susceptible to various illnesses and infections. It is transmitted through sharing injection equipment or through direct contact with the bodily fluids of an infected individual. It most frequently happens during unprotected sex (sex without using a condom or HIV medication to prevent or treat HIV).

Gazette of the medical devices (compounding of faults) regulations 2024

When receiving any information or complaint that a fault which may be compounded has been done, the Authority may, with permission The Public Prosecutor referred to in sub regulation 2(2), issues an offer to compound the offense in Form 2 of the Second Schedule.

An offer to compound an offense is valid for a period of fourteen days starting from the date the offer is received by person to whom the offer is made or any extended period which may be granted by the Authority, and if full payment of the amount the offer is made on or before the expiry of the fourteen-day period or any such extension of time granted, no further proceedings can be taken against the person who committed the offense.

PHILIPPINES

Philippine FDA proposes third delay to medical device deadline to avoid supply disruption

The Philippine Food and Drug Administration (FDA) is planning to delay the deadline for obtaining a Certificate of Medical Device Notification (CMDN) for previously non-registrable Class B, C, and D medical devices.

The agency remains concerned that enforcing the timeline set in March 2023 could disrupt the supply of medical devices in the Philippines. In its latest notice, the agency said it “recognizes the importance of assuring that the availability of medical devices will not be affected” and “understands the need to extend the regulatory flexibility to assist the medical device industry in complying with the regulatory requirements.

Those considerations led FDA to propose allowing Class B, C, and D medical devices to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without a CMDN until 30 September 2024. Under the proposed timeline, companies will have until 30 September to apply for CMDNs.

SINGAPORE

HSA Invites Feedback on Proposed Amendments to Regulation 23 of the Health Products (Therapeutic Products) Regulations

The proposed amendments aim to:

• Provide clarity to industry stakeholders on the types of patents that must be considered when making a registration application for a therapeutic product, and for which the provisions under regulation 23 apply.
• Ensure a system that facilitates all industry stakeholders in making registration applications and minimise any potential indiscriminate use of the mechanism under regulation 23.

SPAIN

The AEMPS launches a procedure for consultations related to the qualification and classification of medical devices, including in vitro diagnostic products

The procedure is intended for any natural or legal person who is developing medical devices or for whom the implementation of the regulations for medical devices or in vitro diagnostics involves a change in the qualification and classification of their products. Likewise, it can be used on those products that, due to the implementation of the regulations, fall within the list of products without an intended medical purpose included in Annex XVI of Regulation (EU) 2017/745.

SWITZERLAND

Swissmedic delays go-live date for swissdamed medical device database

The agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU has not been updated, registration of economic operators (CHRN) and of medical devices and in vitro diagnostic medical devices (unique device identification, UDI) is carried out directly by Swissmedic.

Swissmedic structured around two interconnected modules, which only registered users can access. It also includes a freely accessible search function. The individual modules are being made available in stages.

• Registration of companies and economic operators – ACT module (available in the 2nd half of 2024)
• swissdamed – freely accessible platform (available in the 2nd half of 2024)
• Registration of devices – UDI module (available as a minimal viable product (MVP) 4 months after the ACT module goes live)

UK

Update: Guidance on Regulating medical devices in the UK

This guidance document updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. FDA considers there to be two categories of sterilization methods currently used to sterilize medical devices in manufacturing settings: established and novel. These processes are defined in this guidance document, and examples are provided for each category.