Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)

The purposes of this Regulation:

• Eudamed shall be accessible for authorised users via a restricted website (‘the restricted website’) and for non-identified users via a public website (‘the public website’).
• In order to be granted access to Eudamed via the restricted website, a natural person shall create an account on the Commission authentication service website.
• The Commission shall set up an application support team to provide timely assistance to users of Eudamed, reachable via a dedicated functional mailbox.
• Commission shall be the owner of Eudamed and shall have full administration rights.
• The Commission shall take all necessary measures to prevent any malfunction and to identify it, without undue delay, when it occurs.
• The Commission shall make available to the actors websites for the purposes of testing and training with regard to using Eudamed (‘websites for testing and training’).

EUDAMED UDI/Devices registration module – Relevant documents and information

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.

The European Commission is not in a position to require the use of the UDI/Devices registration module until EUDAMED is fully functional according to the Medical Device Regulation. Therefore, additional national requirements on registrations cannot be excluded

EUDAMED Notified Bodies and Certificates module

The European Commission is not in a position to require the use of the NBs & Certificates module until EUDAMED is fully functional according to the Medical Device Regulation.

Therefore, in EUDAMED, NBs can register certificates and Summaries of Safety and Clinical Performance (SSCP) only on voluntary basis if all of the parties referenced in the certificates are first registered, also on a voluntary basis, in this database. The parties to be registered would include the manufacturer, the authorised representative (where applicable), and/or the system procedure pack producer and the Basic UDI-DI(s) referenced. However, additional national requirements cannot be excluded.

Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines. This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from the prior safety communication. This update also addresses common questions and concerns from consumers, patient organizations, and health care professional societies. As the FDA continues to work diligently on this recall and develop solutions, we will continue to share information with the public and provide additional recommendations to patients and health care providers

The FDA recommends that health care providers:
Discuss the risks and benefits of available pacemaker system options with patients as part of shared clinical decision-making.

The benefit-risk profile of leadless pacing systems compared to transvenous systems or alternative treatment options should be considered for each patient.

Be aware that although cardiac perforation is a rare complication following pacemaker system implant procedures, the risk of major complications following cardiac perforation may be higher in patients who receive leadless pacing systems vs. traditional transvenous pacemakers.

Implanting physicians should be prepared to emergently manage patients experiencing perforation during leadless pacemaker implantation. In some cases, urgent cardiac surgical intervention may be necessary.

Read and carefully follow the Instructions for Use (IFU) and training for the Medtronic leadless Micra Transcatheter Pacing System, which include recommendations about implant location at the right ventricle septum, delivery system steering, repositioning the device, patient selection to minimize perforation risk, stand-by availability of cardiothoracic surgery, and immediate access to echocardiography equipment.

Report any adverse events or suspected adverse events experienced with the Micra Transcatheter Pacing System or other pacemaker systems. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities

Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect

The FDA has recalled Class I Custom Convenience Kits of Aligned Medical Solutions containing the Cardinal Health Monoject Flush Prefilled Syringe including: Leader flex Insertion Kit with Ultrasound, Insertion Tray-RX, Universal Procedure Pack with Split Drape, Port Insertion Pack, and Procedure Pack

Aligned Medical Solutions is recalling its custom convenience kits due to the potential for the plunger of the Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) to draw back after the air has been expelled and reintroduce air back into the syringe.

If a clinician is not aware of air being reintroduced into the syringe, the clinician could inadvertently push air into the vascular system, creating the potential for an air embolism. The use of affected product may cause serious adverse health consequences, including death

5.UK, USA and Canadian regulators identify 10 guiding principles to be addressed when medical devices use AI or machine learning software

These principles are intended to lay the foundation for developing good machine learning practices (GMLP) and will help guide future growth in this rapidly progressing field.

These guiding principles further identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations and other collaborative bodies could work together to advance GMLP. Areas of collaboration include research; creating educational tools and resources; regulatory policies and regulatory guidelines; international harmonization; and consensus standards.