Enrollment Period: 6 months.
Average Learning Time: ~60 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $199.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: EU MDR: EU Medical Device Regulation - Chapter 2: Making Available on the Market
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials 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 course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
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).
EU MDR: EU Medical Device Regulation - Chapter 2: Making Available on the Market is included in the following professional certification programs:
Price: $1295.00 (USD) | Learn more
Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relavancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.
Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
Benefits of Training with Biopharma Institute
- Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
- Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
- Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
- Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
- Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
- Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
- Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
- Purchase orders (POs): If issuing 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.
- Reimbursement: Some employers may reimburse for training expenses. Check 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.
- Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
- Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
- Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
- Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.