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

EUROPE

Second Call for EU Reference Laboratories for High-Risk IVDs Under Consideration

The European Commission, following consultation with Member States through the Medical Device Coordination Group, is assessing the launch of a second call for EU reference laboratories (EURLs) to cover remaining Class D device categories, including arboviruses, biosafety level 4 viruses, parasites, and blood grouping. EURLs perform key functions under Article 100 of Regulation (EU) 2017/746, such as verifying Class D device performance, testing batches at the request of notified bodies, and harmonizing assessment methods across the EU network.

MDCG 2024-1 – Template for Device-Specific Vigilance Guidance

This MDCG guidance aims to support consistent vigilance reporting for specific devices by clarifying expectations for manufacturers under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). It outlines how incidents and serious incidents, as defined in the MDR and IVDR, should be reported to competent authorities in line with the applicable vigilance provisions.

MDCG 2024-2 – Procedures for Updating the European Medical Device Nomenclature (EMDN)

The document details the annual review process and expedited procedures for ad hoc updates to the EMDN. It also outlines stakeholder involvement and the operational workflow for processing revision requests.

Commission Notes Significant Increase in MDR and IVDR Applications

Survey data from the European Commission shows a 35% rise in MDR certification applications between June and October of the previous year. IVDR applications increased by 30%, with certificates rising 40%. For Class D IVDs, filings reached 336 and certificates 119, influencing decisions to extend regulatory timelines.

AUSTRALIA

Updated Guidance on Medical Device Labelling Obligations

The Therapeutic Goods Administration (TGA) has published updated guidance explaining how medical device labelling requirements help manufacturers and sponsors meet their obligations under the Therapeutic Goods (Medical Devices) Regulations 2002. Manufacturers must provide all required information in English and demonstrate compliance with Essential Principle 13. Sponsors must ensure their name and address are indicated on supplied devices in a clear and appropriate manner.

Regulation of Menstrual Cups

The TGA has issued updated guidance on the regulatory framework for menstrual cups, summarizing requirements under Therapeutic Goods Order No. 99, including standards for safety, labelling, and performance.

Updated Information for Prescribers on Vapes

Recent regulatory changes include:

• From 1 January 2024: Importation of all disposable vapes is prohibited, including those ordered online. 
• From 1 March 2024: Personal importation of all vaping substances and reusable vaping devices is banned. 

Patients may access therapeutic vapes only via the Authorised Prescriber Scheme, the Special Access Scheme, or (until the deadline) the personal importation scheme.

Clarification on Smartwatches Measuring Medical Parameters

Anvisa has issued Technical Note 12/2024 stating that any smartwatch or wearable device measuring parameters typically associated with medical use—such as blood glucose, oxygen saturation, blood pressure, ECG, or cardiac rhythm—must be registered with the agency before being marketed.

CHINA

Regulations on Emergency-Use Medical Devices (Trial)

Regulation 2023 No. 150 defines criteria for medical devices intended for emergency use, focusing on products not yet registered in China or whose supply cannot meet urgent public health needs. Class I devices are excluded from emergency-use provisions.

CZECH REPUBLIC

English-Language Guidance on Advertising Medical and IVD Devices

The Czech authority has issued English versions of guidelines related to advertising medical devices and IVDs, available via the national regulatory portal.

ISZP Updates on Power of Attorney and Manufacturer Obligations

New procedures are in place for assigning power of attorney in the Information System of Medical Devices (ISZP). Manufacturers of custom-made devices must verify migrated data, update EMDN classifications, and follow notification timelines mandated by national legislation.

Ethics Committee Activity Notification

The ISZP system will support mandatory notifications concerning ethics committee activities related to medical device and IVD clinical studies. Noncompliance will prevent ethics approvals from being recognized in clinical study applications.

HONG KONG

Supplementary Information Sheet for HA-Procured Devices

Applicants submitting medical device listing applications must include the newly issued Supplementary Information Sheet (MD111) for devices procured by the Hospital Authority, in addition to all other required documentation.

IRELAND

EU4Health Programme – IncreaseNET Joint Action

IncreaseNET, co-funded under the EU4Health Programme and coordinated by Slovenia’s JAZMP, aims to strengthen regulatory capacity across the EU. Running from 2024–2026, the initiative involves 29 partner organisations. HPRA leads Work Package 5 on developing training materials for regulatory stakeholders.

ITALY

Extended Deadline for Registration of Custom-Made Device Manufacturers

Italy has extended the deadline for manufacturers already registered in the pre-existing system to transition to the new online registration platform. The previous lists will be removed from the Ministry of Health website starting 2 May 2024.

Guidance on Distributor and Importer Obligations

Italy has highlighted MDCG 2021-27, which clarifies practical expectations for distributors and importers under the MDR and IVDR, especially regarding verification, documentation, and market surveillance duties.

LATVIA

Mandatory Registration for Medical Device Distributors

The State Medicines Agency reminds all medical device distributors to register in the LATMED database and submit required company and manufacturer information.

MALAYSIA

Requirements for the Placement of HIVST Kits

Guidance has been issued detailing pre-market, market placement, and post-market requirements for HIV self-test kits, including registration, labelling, advertising controls, licensing, and post-market surveillance.

Medical Devices (Compounding of Faults) Regulations 2024

The new regulations allow certain offenses to be compounded upon receipt of an official offer. If paid within 14 days (or an approved extension), no further legal actions will be taken.

PHILIPPINES

Third Proposed Extension for CMDN Submission Deadline

The Philippine FDA plans to postpone the deadline for obtaining Certificates of Medical Device Notification (CMDNs) for previously unregulated Class B, C, and D devices until 30 September 2024 to avoid potential disruptions in device availability.

SINGAPORE

Proposed Amendments to Regulation 23 on Patent Declarations

HSA is consulting stakeholders on proposed amendments to Regulation 23 to clarify patent-related obligations when submitting therapeutic product registration applications and to prevent misuse of the mechanism.

SPAIN

AEMPS Introduces a Consultation Procedure for Device Qualification and Classification

The new procedure assists manufacturers and developers in determining whether their products meet qualification and classification criteria under the MDR and IVDR, including products without an intended medical purpose listed in Annex XVI.

SWITZERLAND

Swissmedic Delays swissdamed Database Launch

Due to the absence of an updated MRA with the EU, Swissmedic will independently manage registration of economic operators and devices. The swissdamed platform will be launched in stages:

• ACT module (registration of companies) – Second half of 2024 
• Public search function – Second half of 2024 
• UDI module (minimal viable product) – Four months after ACT launch

UK

Updated Guidance on Regulating Medical Devices in the UK

New guidance clarifies FDA-recommended sterilization information for 510(k) submissions, distinguishing between established and novel sterilization methods and providing examples for each category.