1.MDCG issues guidance on transitioning devices with ancillary substances to MDR

The European Commission’s Medical Device Coordination Group (MDCG) released guidance detailing how manufacturers should transition CE certificates for medical devices that incorporate ancillary substances classified as medicinal products, as well as devices produced using animal-derived tissues, under the Medical Devices Regulation (MDR).
The guidance also outlines notable changes in regulatory requirements and consultation processes compared with previous EU legislation.

2.European Commission updates on MDR, IVDR implementing measures rolling plan

The European Commission updated its rolling plan outlining forthcoming implementing acts and related measures for the MDR and In Vitro Diagnostic Regulation (IVDR). This update follows the one-year postponement of MDR implementation due to COVID-19 and the two-year delay of Eudamed deployment.

Implementing acts and other activities

The rolling plan lists several upcoming implementing acts concerning

• Reprocessing of single-use medical devices – anticipated in Q3 2020
• Common specifications for devices without a medical purpose – expected Q4 2020
• Designation of expert laboratories – planned for Q3 2020
• EU reference laboratories for IVDs – designations expected Q3 2020, adoption in Q1 2021
• Eudamed support and maintenance – targeted for Q4 2020
• Eudamed Live notification – expected in 2022
• Common specifications for high-risk (Class D) IVDs – Q3 2020

3.Spain: AEMPS reports on the usual procedure for the importation of medical devices

Spain’s Agency of Medicines and Medical Devices (AEMPS) reiterated the standard requirements for medical device importation, including CE marking, completion of conformity assessment procedures, and possession of a valid importer license.
In exceptional and justified circumstances, AEMPS may authorize imports that do not fully meet these criteria, issuing special approvals to ensure safe use during extraordinary situations.

4.UK: Medical devices: software applications (apps)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) published guidance clarifying when software applications qualify as medical devices and outlining the applicable regulatory compliance requirements.

5.Belgium FAMHP: Web portal – updates to the “My company” and “My activities” applications

To align with MDR (EU) 2017/745 and IVDR (EU) 2017/746, Belgium’s Federal Agency for Medicines and Health Products (FAMHP) updated the “My Company” and “My Activities” sections of its online portal.

What are the main changes?

• Inclusion of MDR and IVDR risk classifications
• Planned registration of healthcare facilities involved in in-house manufacturing and reprocessing of single-use devices, subject to legal provisions
• Separation of activities into distinct tables, including those that will later be registered in Eudamed, such as manufacturing, authorized representation, importing, and system/package production

6.Slovenia: Safety notices for Medical devices

The Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) published safety notices received from manufacturers and authorized representatives in April 2020.
Manufacturers are required to notify both JAZMP and device users in writing about corrective safety actions and submit formal reports in accordance with national vigilance regulations.

7.Federal Register: Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet

The U.S. Food and Drug Administration announced a public consultation regarding proposed revisions to information collection requirements under the Paperwork Reduction Act. The update introduces Form FDA 3601a, the “Device Facility User Fee Cover Sheet,” to accompany registration and listing fee payments.

8.Evaluation of Automatic Class III Designation (De Novo) Summaries

The FDA provided updates related to the De Novo classification pathway, established under the FDA Modernization Act of 1997. This pathway allows novel devices initially classified as Class III following a “not substantially equivalent” (NSE) determination to be reclassified through an alternative regulatory route.

9.Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

The Therapeutic Goods Administration (TGA) issued guidance for sponsors seeking assessment of COVID-19 diagnostic tests for inclusion in the Australian Register of Therapeutic Goods (ARTG), including information tailored for organizations new to Australia’s regulatory system.

10.Latest Public notifications have been released

India’s Central Drugs Standard Control Organization (CDSCO) released updated public notifications, including guidelines issued on 4 June 2020 for validation and batch testing of COVID-19 diagnostic kits.

11.Sri Lanka: Extension of Registration and License Validity

Sri Lanka’s National Medicines Regulatory Authority (NMRA) extended the validity of registration certificates and import licenses for medicines, medical devices, cosmetics, and borderline products until 31 July 2020. This extension applies to licenses expiring after 30 June 2019 and aims to reduce public movement during the pandemic.

12.Sri Lanka: Grace Period for Dossier Submissions

NMRA granted a grace period until 30 June 2020 for submission deadlines falling between 15 March and 3 June 2020. Submissions made within this extension will not be treated as new dossiers.

13.Malaysia: Medical Gas System Registration Guidance

Malaysia’s Medical Device Authority (MDA) issued new guidance outlining registration requirements for medical gas systems placed on the market, as defined under the Medical Device Act 2012.

14.Malaysia: Distribution Records Guidance

The MDA also published guidance specifying requirements for establishing and maintaining medical device distribution records. This applies to all relevant establishments, including exporters.

15.Russia: Updated Guidelines for Software-Based Medical Devices

Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) introduced updated methodological recommendations for evaluating the quality, safety, and effectiveness of software-based medical devices for state registration. These guidelines replace the previous version approved in 2018.