GMP News - Medical Devices

End of January 2023 you could already read about a 3.5 page position paper from Notified Bodies regarding their perspective on hybrid audits of medical device and IVD manufacturers. The position paper has now been updated.

One of the most important documents in the context of medical device regulation is the technical documentation. Updated as version 2, a helpful position paper from the Team Notified Body provides assistance in this regard as a best practice guide.

In a 3.5 pages position paper, Notified Bodies have presented their views on hybrid audits of medical device and IVD manufacturers. What does it say?

In October 2022, the Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023), as well as older guidances to be reviewed for topicality. What is planned?

The ECA regularly analyses the deficiencies identified in FDA Warning Letters relating to medical devices. Since medical devices can also be part of a combination product of a medicinal product and a medical device, these statistics are also of interest to manufacturers of these products. What do the medical device Warning Letter statistics show for the 2022 fiscal year?

You could already read in the past about the FDA CDRH's website for medical devices. It provides you with the possibility to get familiar quickly with the topic "medical devices" or to stay up to date. What is new?

The FDA published now a guidance document on Instructions for Use (IFU) labeling. What is the recommended font and font size?