Course Overview
The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself and are critical to the safety and performance of the device and to compliance with regulatory requirements. Regulations for medical devices include particular requirements for labelling and the provision of Instructions for Use. These regulatory requirements relate to general safety and performance aspects of the products, and the requirements for clear and unambiguous information to be supplied to clinicians, patients and other users. Evidence of labelling which includes all required information is important and expected when demonstrating conformity with the regulations.
These requirements have been supported by a portfolio of standards, regulations and guidance documents on:
- Information to be supplied by the manufacturer;
- Symbols to be used with information to be supplied by the manufacturer;
- Unique Device Identifiers (UDIs); and
- Use of electronic labelling
This course provides an introduction to these regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.
CPD Hours: 3
Course Content
- Day 1
- Labels and IFUs
- Labels and IFUs (continued)
- UDIs and Barcodes
Speakers
Annette Callaghan
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
