As per our last RA news update, the proposal for the MDR postponement is for vote today in the EU parliament.
In addition, the proposal was published with comments from Commission and Presidency. Those information provide more in depth understanding on the impact of the postponement. Here you can find the link to the updated proposal:
The TGA provided rules for the 3-D printing and exhorts that even though the fight against the pandemic, some components might meet the definition of a medical device and must be treated like that.
Depending on the class of the device, TGA provides a good overview what requirements and steps must be fulfilled to legally place a device on the market.
Depending on the class of the device, TGA provides a good overview what requirements and steps must be fulfilled to legally place a device on the market:
In addition, TGA grants an expedited way to market for domestic ventilator manufacturers if the following conditions are met:
The FDA updates Question-and-Answer Appendix in Guidance on “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”.
The guidance also includes new content on conducting remote clinician-reported outcome or performance outcome assessments or remote site monitoring.
The Malaysian authority has issued an overview for a clarification when Personal Protection Equipment (PPE) is meant to be a medical device as well and when not. For PPE that is a medical device as well, the approval of the authority is required prior to marketing of the devices.
Simultaneously the authority released a guidance called “SPECIAL ACCESS – REQUIREMENTS FOR VENTILATOR DURING EMERGENCY SITUATION” and clarifies within the procedure to be followed in order to make use of the special and expedited market access.
The MDCG provided updates for two new guidances:
The guidance for “Interpretation of Article 54(2)b - Consultation Clinical Evaluation for Class III implantable and IIb active and medicine administering” clarifies the circumstances what the expression “device already marketed” means and states it cannot be intended to refer to a device already marketed uniquely under the new Regulation.
The second guidance titled “Temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions” relates to auditing in the times of the Corona pandemic.
As a specialty this guidance relates to the Medical Device Directives (MDD, IVDD, AIMDD) only, but will apply as well to MDR and IVDR should the availability of devices be affected by the virus. It states that as alternatives for current on-site audits measures like the following are foreseen:
However, initial certification or scope expansion audits are out of scope for the guidance.
The NMPA has published an update of YY standards this month. The update introduces 12 standards for medical devices and IvD products.
Health Canada revised the guidance “How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device”.
You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.