Medical Devices USA/Europe Regulatory Updates round up, Jul 2021

EUROPE

1. Introduction of Harmonised European Standards for Regulation (EU) 2017/745 – Commission Implementing Decision (EU) 2021/1182 (16 July 2021)

As per Article 8 of Regulation (EU) 2017/745, devices that conform to harmonised European standards, as referenced in the Official Journal of the European Union, are presumed to comply with the applicable requirements of the Regulation.

The following standards are now harmonized:

• EN ISO 10993-23:2021 – Biological evaluation of medical devices: Tests for irritation (ISO 10993-23:2021)
• EN ISO 11135:2014 – Sterilization of health-care products: Ethylene oxide sterilization process (ISO 11135:2014, including A1:2019)
• EN ISO 11137-1:2015 – Sterilization of health-care products: Radiation sterilization process (ISO 11137-1:2006, including Amid 1:2013 and A2:2019)
• EN ISO 11737-2:2020 – Sterilization: Microbiological methods for sterility testing (ISO 11737-2:2019)
• EN ISO 25424:2019 – Sterilization: Low-temperature steam and formaldehyde sterilization (ISO 25424:2018)

2. First References of Harmonized European Standards for Regulation (EU) 2017/746 – Commission Implementing Decision (EU) 2021/1195 (19 July 2021)

The European Commission has requested updates to harmonized standards in support of Regulation (EU) 2017/746. This request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC)includes revising existing standards and drafting new ones.

The standards outlined in the request are as follows:

• EN ISO 11135:2014 – Ethylene oxide sterilization process (ISO 11135:2014, including A1:2019)
• EN ISO 11137-1:2015 – Radiation sterilization process (ISO 11137-1:2006, including Amd 1:2013 and A2:2019)
• EN ISO 11737-2:2020 – Microbiological sterility testing methods (ISO 11737-2:2019)
• EN ISO 25424:2019 – Low-temperature steam and formaldehyde sterilization process (ISO 25424:2018)

3. MDCG 2021-20 – Instructions for Generating CIV-ID for MDR Clinical Investigations in Eudamed2

This document outlines instructions for generating the Clinical Investigation (CIV-ID) for clinical investigations under the Medical Device Regulation (MDR) in Eudamed2. Users are expected to be familiar with general functions in Eudamed2, as this guidance is an additional resource for navigating the system.

4. Quality Documentation for Medicinal Products Used with Medical Device

The guideline outlines the regulatory requirements for combination products that include drug-device combinations, co-packaged products, and devices used with medicinal products. Specific examples include single-use pre-filled syringes, pens, injectors, inhalers, and applicators. It details the information required for submission under the Common Technical Document (CTD) for product registration

US (FDA)

5. FDA Budget Proposal for Medical Device Supply Chain and Shortages Prevention Program

The FDA Acting Commissioner Janet Woodcock has advocated for new funding to strengthen the medical device supply chain. The pandemic revealed vulnerabilities in the supply chain, especially its reliance on foreign devices. Additional resources and expanded authority are necessary to secure the future of the U.S. medical device industry.

CANADA

6. Medical Devices No Longer Considered to Have Urgent Public Health Need Status: Notice to Industry

Health Canada has reviewed the status of COVID-19 medical devices and determined that certain categories no longer meet the criteria for urgent public health need (UPHN). Devices that no longer have UPHN status will be reassessed periodically to reflect changing pandemic conditions and supply needs.

7. Guidance on Classification of Products at the Drug-Medical Device Interface

Health Canada has revised its guidance document to reflect the newly implemented Ministerial Schedule, which streamlines the classification of products that meet multiple definitions (e.g., drug, food, device, cosmetic). The changes aim to enhance consistency, predictability, and transparency in the regulatory process.

8. Classification of Products Under the Food and Drugs Act (F&DA)

This guidance document provides the foundational regulations for the classification of drugs, devices, food, and cosmetics in Canada. It outlines the four main regulatory sets under the F&DA: the Cosmetic Regulations, the Food and Drug Regulations, the Medical Devices Regulations, and the Natural Health Products Regulations.

9. Drug and Medical Device Highlights 2020: Health Canada’s Accomplishments

Health Canada’s 2020 highlights report summarizes new drugs and medical devices approved for sale in Canada. It also outlines the department’s efforts to ensure timely access to safe and effective health products for Canadians during the year.rmation we published about these products, and our other accomplishments in 2020.