GMP News - Medical Devices

Due to the Corona pandemic, there were supply shortages of medical device products in the USA. To get these shortages under control in the future, the FDA gets expanded power. What is planned?

Combination products are products that are subject to different sets of regulations. Such products may, for example, consist of a drug and a medical device, or a biological component may be added. Because of the different product components, special monitoring procedures are required.

With the EU regulations 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostics (IVDR) coming into force on May 21, 2021, new requirements have been/will be imposed on combination products with regard to their medical device component. There is an updated question and answer document (Q&A) from the European Medicines Agency on current issues.

Due to the new EU Regulation on Medical Devices (2017/745) and failed negotiations between Switzerland and the EU, the corresponding Mutual Recognition Agreement (MRA) will become obsolete. This has far-reaching consequences.

The USP Packaging and Distribution Expert Committee intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.

Combination products in the US are separately regulated by the FDA via GMP regulations. A dedicated FDA website provides guidance on combination products. 

Due to the Covid-19 pandemic, on-site audits by Notified Bodies are partly only possible to a limited extent or not at all. What are the alternatives? A guideline of the Medical Device Coordination Group (MDCG) provides information on this.