1.Brexit Preparedness Measures

On 9 July 2020, the European Commission issued formal Communication to support national authorities, businesses, and citizens in preparing for changes following the end of the Brexit transition period. From 1 January 2021, cross-border trade and regulatory interactions between the EU and the UK will change, regardless of whether a future partnership agreement is finalized.

2.Sponsor Obligations for Ongoing Compliance with EU Clinical Trial Legislation

Following the UK’s withdrawal from the EU on 1 February 2020, it is considered a “third country.” The Withdrawal Agreement established a transition period ending on 31 December 2020, with no extension requested as of 1 July 2020.

Under Directive 2001/20/EC, specific establishment requirements apply:

• The Qualified Person (QP) must be based within the EU/EEA (Article 13(2)).
• The clinical trial sponsor or its legal representative must also be established within the EU (Article 19).

These requirements remain critical for maintaining regulatory compliance.

3.GMED Designated as Notified Body under EU MDR

GMED, a recognized medical certification organization, has been officially designated as a Notified Body in France under Regulation (EU) 2017/745 on medical devices. Notified Bodies are responsible for conformity assessment and issuing CE certificates required for EU market access.

The designation, published in the European Commission’s NANDO database on 8 July 2020, took effect on 7 July 2020 in accordance with Article 42(11). This follows a rigorous evaluation process designed to ensure patient safety and regulatory robustness.

4.Adoption of Revised Medical Device Ordinances

On 1 July 2020, the Federal Council approved revisions to the Medical Devices Ordinance (MepV) and adopted a new Ordinance on Clinical Trials for Medical Devices (KlinV-Mep). These regulations enhance device safety and quality and serve as implementing measures for the Therapeutic Products Act and the Human Research Act approved in 2019, aligning national law with updated EU requirements.

5.Mandatory Electronic Submission of Medical Device Regulatory Filings

Amendments to the Federal Food, Drug, and Cosmetic Act require that certain medical device submissions—including pre-submissions, 510(k)s, PMAs, IDEs, and related supplements submitted electronically in FDA-specified formats. This requirement stems from Section 745A(b) of the Act, as amended by the FDA Reauthorization Act of 2017, and takes effect based on timelines outlined in FDA final guidance.

6.Draft Guidance Updates for BPH Treatment Devices

The FDA issued draft guidance proposing targeted updates to its existing guidance on non-clinical and clinical investigations of devices used to treat Benign Prostatic Hyperplasia (BPH). Until finalized, the current guidance remains valid. Once public comments are reviewed, FDA plans to integrate the updates into a single consolidated final guidance.

7.Select Updates for Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

FDA released draft guidance proposing selective updates to the existing guidance on premarket notification [510(k)] submissions for peripheral vascular atherectomy devices. Sections not impacted by the proposed updates will remain unchanged. Following public consultation, the revised content will be merged into a unified final guidance document.

8.FDA prepares for resumption of domestic inspections with new risk assessment system

After postponing inspections in March 2020, FDA developed a new risk assessment framework to determine when and how to safely resume prioritized domestic inspections of regulated facilities.

9.FDA delays UDI enforcement

FDA announced enforcement discretion for Unique Device Identification (UDI) direct marking requirements. This applies to certain device classes manufactured and labeled before their applicable compliance dates and remaining in inventory, extending timelines for compliance through September 24, 2022, for specified device categories.

10.US FDA publishes final guidance outlining standard inspection procedures

FDA published final guidance outlining standardized inspection procedures intended to streamline inspections and improve efficiency without imposing unnecessary burden on device manufacturers. These procedures do not apply to for-cause inspections, which may still occur without prior notice.

11.Summary Basis of Decision (SBD) for TULSA-PRO system

On 20 November 2019, Health Canada granted a Class III medical device license to Profound Medical Inc. for the TULSA-PRO system. Approval was supported by preclinical and clinical evidence demonstrating an acceptable benefit-risk profile for the thermal ablation of low- to intermediate-risk, organ-confined prostate cancer using MRI-guided transurethral ultrasound technology.

12.Reduced annual Charges for Medical devices listed on the prostheses list

In response to COVID-19–related disruptions and the suspension of elective surgeries, the Australian Government approved a 50% reduction in annual charges for eligible medical devices. This reduction applies during the 2020–21 financial year to ARTG-listed Class IIa, IIb, III, and Active Implantable Medical Devices (AIMDs).

13.Revised Essential Principles of safety and performance of Medical Devices

Hong Kong revised its Essential Principles of Safety and Performance for Medical Devices, adapted from the GHTF guidance document GHTF/SG1-N41R9:2005. Manufacturers and Local Responsible Persons must ensure full compliance for devices regulated under the Medical Device Administrative Control System (MDACS).

14.Announcements: Updated GMP certification checkpoint” for export certification

Japan announced updates to GMP certification checkpoints related to export certification of medical equipment. Certification procedures continue to be administered by the Overseas Medical Equipment Technical Association (OMETA).