Who needs to comply with EU MDR 2017/745 - Module 2
EU MDR 2017/745 - Module 2 - Chapter II primarily applies to manufacturers, authorized representatives, importers, and distributors of medical devices within the European Union (EU). The manufacturers, irrespective of their location globally, must ensure their devices meet the stringent requirements set forth in this regulation before entering the EU market. Authorized representatives play a crucial role in serving as the primary contact for regulatory authorities and are responsible for ensuring manufacturer compliance. Importers and distributors, who form the supply chain, must adhere to the obligations specified in Chapter II. This includes verifying CE marking and the accompanying EU Declaration of Conformity, ensuring appropriate storage and transport conditions, and collaborating with the competent authorities in case of non-compliant devices. Even though not directly addressed, healthcare providers and users are also indirectly impacted and should be aware of these regulations to ensure safety and effectiveness of devices.
About the Course
In Module 2, Chapter II of EU MDR 2017/745, we cover the obligations of Economic Operators and the processes involved in making a product available in the EU. We will delve into pre-market, post-market, and on-market activities and explore product claims that impact labeling, instructions for use, and advertising. Additionally, this chapter includes harmonized standards and common specifications, implant cards, EU Declaration of Conformity, CE Marking of Conformity, and more.
Article 5 - 9
MDR guide for manufacturers in designing, producing, and labeling medical devices to ensure safety and performance.
Article 10 - 16
EU MDR establish responsibilities for manufacturers, covering device safety, performance, clinical evaluation, post-market surveillance, risk management, and conformity assessment.
Article 18 - 24
EU MDR (Medical Device Regulation) define the obligations of manufacturers, authorized representatives, importers, and distributors regarding device traceability, registration, and incident reporting.
Example Curriculum
- Article 10 - General obligations of manufacturers
- Article 11 - Authorized representative
- Article 12 - Change of Authorized Representative
- Article 13 - General Obligations of Importers
- Article 14 - General Obligations of Distributors
- Article 15 - Person Responsible for Regulatory Compliance
- Article 16 - Cases in which obligations of manufacturers apply to importers, distributors or other persons
- Article 17 - Single-use Devices and their Reprocessing
- Intermediate Quiz
eQMS for Better Time to Market
Orcanos eQMS (Electronic Quality Management System) is designed to accelerate the certification of MDR (Medical Device Regulation) by offering comprehensive tools for streamlined compliance, process automation, and traceability. Its in-built MDR templates aid in seamlessly integrating compliance requirements into existing workflows. The system supports the capture and management of product design, quality processes, and regulatory affairs documentation in one centralized location. This interconnectivity enhances efficiency, improves data integrity, and reduces manual work.
Moreover, Orcanos eQMS has a risk management module which aligns with ISO 14971, an essential component of MDR. It helps manufacturers identify, evaluate, control, and monitor the risks associated with a medical device throughout its lifecycle. It also includes traceability matrix capabilities to ensure complete traceability from user requirements to risks and mitigations.
By optimizing these processes and reducing the risk of non-compliance, Orcanos eQMS can significantly shorten the time required for MDR certification, thus accelerating time to market for medical devices.
Example Featured Products
Orcanos offers the ALM system, Design Control, Risk Management, and QMS courses, Compliance Coaching, and a Design Control Project Management Course for efficiency in medical device and software industries.
