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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of Attending
- Gain an overview of the information that needs to be supplied with medical devices
- Understand how the use of symbols can overcome language and translation barriers
- Learn the regulatory requirements for use of UDIs in the UK, EU and USA
- Gain an awareness of the ways in which information can be provided to customers
Certification:
- CPD: 3 hours for your records
- Certificate of completion
Agenda
Labels and IFUs
- What is a label?
- Regulatory requirements for product labels in the UK, EU and USA
- Managing labelling with an ISO 13485 quality management system
- Use of symbols on labels and IFUs
- Requirements for translation of label information
- Electronic labelling
- Marketing literature
- When do you need an IFU?
Labels and IFUs (continued)
- Information to be provided with a medical device
- Validation of labelling systems
- Chemical indicators and the ISO 11140 standard
UDIs and Barcodes
- Regulatory requirements for barcoding in the UK, EU and USA
- Basic UDIs, GMNs and GTINs
- UDI carriers, Human Readable Information and UDI databases
- Eudamed and its use within the EU
Speakers
Annette Callaghan,
Sterile Management SystemsA 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).
Who Should Attend
- Regulatory Compliance specialists
- Quality Management System (QMS) specialists
- Internal Auditors
- Regulatory and Quality professionals
