Seminar MDR – Medical Device Regulation
On 25 May 2017, the Medical Device Regulation, MDR, became effective. This seminar supports you in meeting the EU regulation's requirements with a minimum of effort.
Learning Objectives and Content of the One-Day Seminar on MDR
Upon expiry of the transitional period, all manufacturers, distributors, EU-Representatives and importers of medical devices must comply with MDR's requirements. During this training, you will learn which requirements you and your company must know, understand and meet.
Content of the Seminar
This seminar is a concise introduction into the topics of development, quality assurance and approval of medical software (stand-alone software or medical device software). It especially addresses everyone aiming at getting a quick and comprehensive overview of the following topics:
- The most important amendments at a glance
You will gain a quick overview of issues to be tackled during the transition to MDR.
- New concepts and actors
MDR introduces new roles such as "economic operators", "Medical Device Coordination Group", "expert panels" and "Person responsible for regulatory compliance". Additionally, you will learn to understand new concepts such as "Common Specifications" as well as the relevance of harmonized standards.
- Classification and conformity assessment procedures
You will know the new classification rules which have e.g. changed for producers of standalone software. Also, you will get to know the "new" conformity assessment procedures and how they differ from the ones laid out in the MDD.
- Essential performance and safety requirements
The extend of MDD's Annex I with its "essential requirements" has multiplied. You will get to know the new legal requirements including requirements with respect to the technical documentation according to Annex II.
- UDI, EUDAMED, registration
Among the most prominent changes introduced by the MDR is the requirement of a clear identification of products and the recording of this UDI, alongside much further information, within the EUDAMED. You will learn how to meet these requirements, even as a developer of stand-alone software.
- Post-Market Surveillance PMS, Post-Market Clinical Follow-Up PMCF, clinical evaluation
The requirements regarding clinical evaluation, "Post-Market Clinical Follow-Up" and post market surveillance (PMS) are hardly comparable to the ones under the MDD. You will get an overview of those requirements, of demanded plans for PMS and PMCF as well as of reports, especially the "Clinical Evaluation Report", the "Post-Market Surveillance Report" and the "Perodic Safety Update Report". Upon request, the new requirements on clinical trials are also presented.
Hence, this seminar does not only impart comprehensive knowledge to you, but also the skills to rework your quality management system, particularly your processes and specifications, in order to develop your medical devices, to market them and surveil them in compliance with MDR.
Beginning of the seminar
|09:30||Background, regulatory map, amendments at a glance|
|10:00||Actors and roles|
|10:45||Classification and conformity assessment procedure|
|11:30||Safety and performance requirements, technical documentation, "Common Specifications" and harmonized standards|
|13:30||UDI, EUDAMED, Registration|
|14:14||Post-Market Clinical Follow-Up (PMCF), clinical evaluation, clinical trials (upon request)|
|15:15||Post-Market Surveillance PMS, vigilance|
|16:30||Miscellaneous, pending questions|
|17:15||Questions and answers session, typically until 18:00|
We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.
The seminar addresses everyone involved in development for medical devices, especially
- Regulatory affairs managers
- Quality Managers
- Project leaders
- Managing directors
- Development managers, developers
The seminar is also suited for beginners and everyone who "just" wants to get an overview of MDR. The trainer will adjust the level of detail the issues are covered depending on the participants' expectations.