The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
This webinar will look at what to expect when the new regulation is implemented.
Objectives of the Presentation
Why Should you Attend
- The Updated Regulation
- Implementation Dates and Transition
- Main Changes and Products Affected
- Effect on Medical Device Manufacturers
As a medical device manufacturer, importer or distributor it will be critical to have a good understanding of the new regulations, the scope and full impact on the business. Many companies will have combination products and so both the changing pharmaceutical and medical devices regulations are relevant. And the current Directive will be significantly altered and replaced by a regulation which is legally binding on all member states. Attend this training to understand new regulation.
Who will Benefit
- Review of the structure of the new regulation
- Overview of impact areas of regulatory change
- Product Classification
- Clinical data PMS and PMCF/clinical evaluation reports
- Transition arrangements
- Technical documentation requirements
- Unique device identification
- Economic operators
- Technical data including risk management
Top management; Regulatory management; Quality Management; Sales and Marketing Management; Quality Engineers; Personnel involved in development and implementation of the QMS; Clinical research and medical operations; Project Managers; Product Development personnel; Manufacturing personnel; Researchers managing Medical Device R&D and Development; Quality Assurance such as GMP, GCP Auditors; Clinical trial supply personnel; CRO personnel; All personnel who need to understand the procedures and impact of placing Medical Devices on the Market in the EU (25 expanded countries).