Method of Training: Online / Self-paced eLearning.Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $199.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: EU Medical Device Regulation (EU MDR) - Chapter 2: Making Available on the Market
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. Welcome to EU MDR 2017/745 - Module 2 - Chapter II - Making available on the market and putting into service of devices, Obligations of Economic Operators, Reprocessing, CE Marking, Free Movement. This Chapter expands on some of the definitions given in Chapter I and introduces activities to be undertaken by Economic Operators before a product is placed on the market, when it is placed on the market and after it is placed on the market in the European Union.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
EU Medical Device Regulation (EU MDR) - Chapter 2: Making Available on the Market course is included in the following Professional Certification Programs:
Learning Objectives for this Module
Articles 5 to 9
Article 5 - Placing on the Market and Putting into Service
Article 6 - Distance Sales
Article 7 - Claims
Article 8 - Use of Harmonized Standards
Article 9 - Common Specifications
Articles 10 to 16
Article 10 - General Obligations of Manufacturers - Part 1
Article 10 - General Obligations of Manufacturers - Part 2
Article 11 - Authorized Representative - Part 1
Article 11 - Authorized Representative - Part 2
Article 12 - Change of Authorized Representative
Article 13 - General obligations of Importers - Part 1
Article 13 - General obligations of Importers - Part 2
Article 14 - General obligations of Distributors
Article 15 - Person Responsible for Regulatory Compliance - Part 1
Article 15 - Person Responsible for Regulatory Compliance - Part 2
Article 16 - Cases in which Obligations of Manufacturers Apply to Importers, Distributors or Other Persons
Articles 18 to 20
Article 18 - Implant Card and Information to be Supplied to the Patient with an Implanted Device
Article 19 - EU Declaration of Conformity
Article 20 - CE Marking of Conformity
Articles 17 to 23
Article 17 - Single-Use Devices and their Reprocessing
Article 21 - Devices for Special Purposes
Article 22 - Systems and Procedure Packs - Part 1
Article 22 - Systems and Procedure Packs - Part 2
Sterilization of Systems and Procedure Packs
Article 23 - Parts and Components
Article 24 - Free Movement
Article 24 - Free Movement
This training program has been developed to train employees with Intermediate Knowledge of The European Union Medical Device Regulation (EU MDR).
Online Training: The Benefits of Remote Learning & eLearning
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
- Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
- Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
- Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
- Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
- Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.