The May 2017 release of a new MDR in the Official Journal of the European Union marked the start of a three-year transitional period within the medical devices industry. Manufacturers, suppliers, notified bodies, and national competent authorities must comply with the new regulation which was to take effect in May 2020 but has been postponed one year due to the COVID-19 virus. The changes made in the new MDR are significant and immense. This paper will take you through the key points to understand.
You may also be interested in:
White Paper
Indication Expansion
A single product candidate that provides clinical benefit across multiple indications and patient populations allows more conditions to be treated…
Newsletter
Global Clinical Regulatory Services Newsletter
This quarterly eNewsletter will keep you informed of regulatory news and trends as it relates to the clinical development industry and insights from…
White Paper
Chemistry, Manufacturing, and Controls (CMC) in Drug Development and Life Cycle Management
This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development.…