1.Gradual Resumption of Clinical Trials Involving Participants

During the COVID-19 pandemic, most clinical trials were suspended across Europe. As governments, including the Netherlands, progressively eased public health restrictions, opportunities emerged to cautiously restart paused trials or initiate new ones. This applies specifically to clinical trials conducted outside Clinical Research Units (CRUs). To resume or commence such studies, sponsors must comply with defined regulatory conditions. These provisions apply to trials governed by the Medical Research Involving Human Subjects Act (WMO).

2.Updates on Advertising Authorizations and Deposit Returns

Advertising approvals for medical devices (MDs) and in vitro diagnostic medical devices (IVDs):

For MDs and IVDs requiring prior authorization for advertising, applications may be submitted at any time throughout the year. The French regulatory authority (ANSM) has a two-month review period from the receipt of a complete dossier to either approve the request or issue a justified rejection. If no response is provided within this timeframe, authorization is granted by default.

For applications under review during the legally protected period (12 March to 23 June 2020), the evaluation timeline was paused and resumed on 24 June 2020 for the remaining duration. If no decision was issued at the end of this resumed period, approval is considered implicit.

For applications both initiated and due to conclude during the protected period, the evaluation start date was deferred to 24 June 2020, with implied approval effective if no decision was issued by 24 August 2020.

Extension of existing advertising authorizations:
Advertising visas set to expire between 12 March and 1 December 2020 were automatically extended until 31 December 2020, provided no modification or termination decision had been issued.

3.BASG tariff Valid from July 1st, 2020

The Austrian Federal Office for Safety in Health Care (BASG) implemented a revised fee ordinance under the GESG framework. The updated tariff applies to all submissions received by BASG from 1 July 2020 onward.

4.Impact of European Medical Device and IVD Regulations on Australia

In alignment with the European Medical Device Regulations, the Australian Government announced a delay in implementing certain domestic medical device reforms. Manufacturers were granted an additional six months beyond the EU MDR implementation date in May 2021—until November 2021—to rely on overseas certifications, helping reduce regulatory burden and transition challenges.

Recognized overseas conformity assessment pathways:
The Therapeutic Goods Administration (TGA) continues to accept several international regulatory approvals for both pre-market authorization and post-market compliance, including:

• European certification: Valid EC Certificates issued under existing EU Directives will be accepted until expiry or May 2024, whichever occurs first.
• Comparable international approvals: Certifications from the U.S. FDA, Health Canada, Japan’s MHLW/PMDA, and Medical Device Single Audit Program (MDSAP) are recognized as alternative pathways for ARTG inclusion.
• TGA conformity assessment: Manufacturers may also apply directly for conformity assessment certification through the TGA.

5.Transition to Updated GMP Requirements

Effective 1 July 2020, the TGA adopted the PIC/S Guide to Good Manufacturing Practice (PE009-14) as the governing manufacturing standard for medicines and active pharmaceutical ingredients, excluding Annexes 4, 5, and 14. This update replaced the previous PE009-13 version adopted in 2018 and aligns Australian GMP expectations with current international standards.

6.Guidance Document on Complaint Handling

The Malaysian Medical Device Authority released updated guidance outlining mandatory complaint handling requirements for medical devices. The document applies to all establishments involved in medical devices, including exporters, and defines expectations for effective complaint management systems.

7.Checklist for Import No Objection Certificates

The Drug Regulatory Authority of Pakistan issued a public notice providing a checklist for obtaining a No Objection Certificate (NOC) for importing unregistered or unavailable medical devices under the Medical Devices Rules, 2017.

8.Cybersecurity Enhancements for Medtronic Conexus™ Telemetry

Medtronic initiated a second phase of software updates to strengthen cybersecurity protections for Conexus™ Telemetry systems. Healthcare professionals can work with local Medtronic representatives to install updates on programmers. Patient devices will automatically receive the update during routine interrogation sessions. No additional patient visits are required, and no patient harm has been reported.

9. Software Update Addressing Longevity Estimator Error

Medtronic issued a Dear Healthcare Professional Letter detailing software updates to correct a potential longevity estimator error affecting certain implanted cardiac devices. The updates are being released in two phases, scheduled for June 2020 and later in 2020. Communication also provides device-specific patient management recommendations for healthcare professionals.