(EU) 2017/745 Medical Device Regulation (MDR) Training

As is known, as of 26 May 2021, the (EU) 2017/745 Medical Device Regulation, which came into force on 26 May 2017, is being implemented instead of the 93/42/EEC Medical Device Directive and the 90/385/EEC Active Implantable Medical Device Directive. The new regulation imposes more obligations on all stakeholders in the medical device sector, including manufacturers, importers, authorized representatives and notified bodies, and contains more stringent requirements. In addition, the EU Commission determines the requirements for the details and implementation of certain processes with a number of guidance documents, in addition to legal regulations. Although they are not as binding as legal regulations, the EU Commission recommends that these guidelines be taken into account and implemented by the manufacturer in order to fulfill the relevant legal obligations. The scope of this training will include MDR requirements and applications of some relevant guides. 

Purpose of Training:

The aim of this training is to understand the purpose and requirements of MDR, to comprehend the changes according to MDD, to determine the scope and effects of MDR, and to interpret the newly introduced requirements with MDR.

Content of the Training:

MDR Fundamentals

MDR Scope

Obligations of Economic Operators

PRRC Role

Conformity Assessment Processes

Consultation Processes

Device Classification

Technical Documentation Requirements

Clinical Evaluation Processes

Post-Market Surveillance Processes

General Safety and Performance Requirements

UDI Requirements

Eudamed Database

Declaration of Conformity

Bespoke Medical Device Requirements

Who Should Participate:

• Licensing Experts
• Medical Device R&D Engineers
• Medical Device Manufacturers
• Internal and External Auditors
• Quality Managers
• Development, Production and Marketing Managers
• Clinical Experts
• Importer, distributors
• Authorized representatives
• People who want to improve themselves in MDR
• Consultants
• Health Institutions
• Reprocessing Processes

Benefits of Education:

Understanding the general concept of MDR

Ability to interpret new legal requirements emerging with MDR 

Gain a general perspective on the efficient and safe production of medical devices in accordance with MDR

Ability to understand the responsibilities and obligations defined under the MDR for all economic enterprises

Ability to understand technical documentation requirements in accordance with MDR.

Ability to understand clinical data requirements in accordance with MDR.

Ability to analyze the impact of MDR on quality management systems

Reference Sources:

(EU) 2017/745 Medical Device Regulation

MDCG Guides

Tuition Fee:

Please send an e-mail to info@udem.com.tr to get information about training fees. If there are 3 or more participants from the same company/institution, a 10% discount will be given. A 10% discount will be provided for participants who register early.

Education Record:

To complete the training registration, please fill out the training registration form in the link below and send an e-mail to info@udem.com.tr.

Detailed Information:For detailed information about the training, you can contact us through the following communication channels.

Tel: +90 312 4430390

Mail: info@udem.com.tr