Medical Device Directive (MDD) to Medical Device Regulation (MDR) Transition CourseBSI Group
The Medical Devices Regulation has replaced the Medical Device Directive (93/42/EEC) as the legislation detailing the requirements which manufacturers have to meet to place medical devices on the market in the European Union. Publication of the text in spring 2017 marked the start of a three year transition period for manufacturers to meet the new requirements.
This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
This course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). All medical devices and identified devices without a medical purpose will need to undergo a conformity assessment procedure based on the new MDR requirements, in order to place devices on the European Union market. The course will give a general guideline of how to approach application of the new MDR, and will highlight the differences to the MDD that will affect all manufacturers.
The new requirements will also have implications relating to an organization’s quality management system (QMS), specifically: Auditing, requirements for clinical evaluation and technical documentation, post-market surveillance, vigilance reporting, and accessibility of information across European member states, as well as to the public and end users.
Please note: This course does not focus on mapping the active implantable medical devices (AIMD) to the MDR, however, the course will provide value to AIMD clients by looking at the new regulation and how to transition to the MDR. It will also not cover In Vitro Diagnostic Devices.
Hur påverkar COVID-19 denna utbildning?
Vi på utbildning.se är övertygade om att kunskap driver människor och organisationer framåt. Det gör även de arrangörer vi samarbetar med.
Många utbildningar ställs exempelvis om från klassrums- till distansutbildning.
För att ta reda på om en utbildning påverkas med anledning av COVID-19, kontakta gärna arrangören.
Delegates will be able to:
- Explain the changes in the structure and administration of the regulation
- Recognize new economic operators affected by the regulation
- Identify key changes to the requirements concerning the following steps for conformity assessment:
- Check device is within the scope of the MDR
- Determine risk class of device
- Select conformity assessment procedure
- Identify applicable safety and performance requirements
- Assemble technical documentation
- Apply conformity assessment procedure
- Assign unique device identification (UDI)
- Complete Declaration of Conformity (DoC)
- Affix CE mark
- Post-Market Surveillance and Updates
- Explain the main impacts on the QMS relating to the above steps, including:
- Frequency, extent and conduct of audits
- Electronic data management and public access to data
- Clinical investigations, clinical evaluation and post-market surveillance
- Roles of commercial partners
- Communicate the transition arrangements as stipulated within the regulation
- It's a 1-day course.
- The training and materials will be provided in English
- Lunch and drinks are included
- The training course will take place on several dates.
The price of this training course is € 800,-
Examen, diplom m.m.
On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.
BSI is your business improvement partner.
We have shaped best practice for over 100 years, helping organizations around the world embed excellence, build competence and capability for sustainable growth. Through our expertise we transfer knowledge through ongoing training, information and performance tools; we help clients comply...
2 150 SEK
7 900 SEK