Live Webinar – Regulation 745/2017 on Medical Devices: technical file structure
110 min + 10 min. Question Time
Prerequisite: basic knowledge of medical devices
Annex I and Annex II of MDR; main contents expected in the technical file.
Why You Should Attend:
The new Regulations on medical devices has finally arrived
On 5 April, 2 new Regulations on medical devices were adopted. These replace the existing Directives.
The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.
The new Regulations in a nutshell
The new Regulations contain a series of extremely important improvements to modernise the current system. Among them are:
More information is available in this presentation that contains general information on key changes contained in the Regulations and transitional periods.
The main reasons behind this change
Problems with diverging interpretation of the current Directives as well as some incidents with breast implants and metal hips highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. Such problems should not occur again and the safety of all medical devices available in the EU has to be strengthened. Moreover, revision of the legislation was necessary to consolidate the role of the EU as a global leader in the sector over the long-term and to take into account all technological and scientific developments in the sector.
The new regulations will ensure:
Who Will Benefit:
Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.
Online Training Programs Includes:
Live Course Presented and Commented by:
Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.