Emergo Group Archives - Medical Design Sourcing

Alarming results and some good news from MDR and IVDR survey of notified bodies

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By Annette Van Raamsdonk and Evangeline Loh, Emergo by UL

The European Commission (EC) posted a July 25 update on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications.

The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.

Study on medical devices and Notified Body survey instrument

The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.

The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.

The collected data have been compared with data…

Mexico Ministry of Health updates rules and requirements for medical device classification

Ana Karen Hidalgo Rodríguez, Emergo Group

Continuing with our updates over the recently released 5.0 edition of the Supplement of Medical Devices of the Mexican Pharmacopoeia (hereafter: Pharmacopoeia), we discuss the classification rules related to medical devices.

Classification of medical devices based on their level of risk

Appendix II of the Mexican Pharmacopoeia includes the criteria under which medical devices are classified in Mexico based on their risk level.

The established criteria have always been presented as rules, indicating the characteristics of medical devices in relation to their use, activity, contact and permanence with the body. The rules-based system is based on the former Global Harmonization Task Force (GHTF), now the International Medical Device Regulators Forum or IMDRF, and EU Medical Devices Directive MDD 93/42/EEC. In addition, the revised rules appear to consider the EU Medical Devices Regulation 2017/745 (MDR). Understand…

FDA updates guidance on identifying and responding to deficiencies

Kathryn Burke, Emergo Group

The FDA has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the considerations on identifying and responding to deficiencies in premarket submissions. The document supersedes the one of the same title issued on Nov. 2, 2000.

The revised document further clarifies the content and format of a deficiency letter and includes a new list of examples of deficiencies and applicant responses.

Guidance on requesting additional information for market registration

The FDA has finalized the guidance document to help agency staff develop requests for additional information needed to make a decision on a medical device marketing application. Requests for additional information for medical device marketing applications are known as deficiencies. The guidance also recommends the most efficient formats for agency and industry to send or reply to such deficienc…

FDA’s breakthrough medical device designations tally nears 700

Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases.

According to recent metrics published by FDA, the agency has issued a total of 693 designations under its Breakthrough Devices Program, previously known as the Expedited Access Pathway (EAP). As of June 30, 2022, the bulk of these designations (687) have come through FDA’s Center for Devices and Radiological Health (CDRH), while the Center for Biologics Evaluation and Research (CBER) has granted another six such designations.

Although nearly 700 devices have been granted breakthrough designation, only 54 of these devices have obtained full US marketing authorizations.

Breakthrough designations gaining pace in recent years

FDA data shows that the …

FDA releases notification requirements to protect medical device supply chains

By Stewart Eisenhart, Emergo Group

The FDA has published new guidance on reporting and notification requirements to better mitigate supply disruptions when medical device manufacturers cease or suspend production during public health emergencies.