Medical Device Regulation
Medical Device Regulation
The medical device industry has had its new legal obligations since May 2017, the Medical Device Regulations or MDR for short. This new regulation replaces the "Active Implantable Medical Devices Directive" (AIMDD 90/385 / EEC) and the "Medical Device Directive" (MDD 93/42 / EEC). The final transition deadline is "only" in May 2020, but starting today is necessary to meet this deadline.
This highly anticipated MDR provides in-depth assessment of technical documentation; it deals with product safety and performance assessment by setting stricter requirements for clinical evaluation and clinical post market follow-up, and it requires better traceability of medical devices through the supply chain.
To meet the requirements set in the MDR, it is advisable to implement a quality management system (KMS). A well-implemented system guarantees that all (legal) requirements are met, that non-compliance, defective or incorrectly manufactured products are detected, that traceability is carried out within all processes and that new products are inspected before being placed on the market. .
The management of the organization is responsible for the KMS and leadership and active participation are expected, commitment must be demonstrated. Within the KMS one person will be designated who has responsibility and authority to implement and maintain the system, a quality manual will also have to be drawn up describing all activities and being systematically assessed (Record, document the role of the organization ISO 13485: 2016, 4.1.1). All critical elements of the distribution process will have to be checked, changes will have to be viewed and approved. In some cases even to be validated
Tracing the medical devices is a very important topic in the MDR. To monitor patient safety, it is necessary that these products can be traced at any time in every phase of the supply chain.
Download the MDR flowchart here
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