Medical Device Reporting (MDR) - By Compliance Global Inc.

Overview
Manufacturers of Medical Devices are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction was to be reoccur. The Medical Device Reporting (MDR) regulation (21 CRF 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their components that are used to produce or assemble the final device may have caused or contributed to a death or serious injury. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur.

Why Should You Attend
The FDA expects health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality, and therapeutic failures. The overall intent of this webinar, just like FAA for passenger safety is to provide critical information that helps improve patient safety.

Areas Covered in the Session
As mentioned above, the FDA encourages healthcare professionals, patients, caregivers and consumers to submit voluntary reports of significant adverse events or product problems with medical products to MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

We are going to talk at length about Customer Complaints a little later in this webinar. Each manufacturer must establish and maintain procedures to control all documents that are being used for the generation and distribution of medical devices. To meet Quality System guidelines (expectations, regulations, etc.) , procedures need to provide but not limited to the following:
1 Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).
(a) Document approval and distribution. Each manufacturer need to designate an individual(s) to review for adequacy and approve prior to issuance the documents generated to meet the requirements of the Quality System generated to be compliant with 21 CRF 820. The approval, including the date and signature of the individual(s) approving the document, are to be documented. Documents established within a company should be available at each location within the company as applicable, important to know and understand the difference between Policies, Practices (internal guidelines) and Procedures. Procedures require documented evidence of compliant performance by operators

2 (b) Document changes. Changes to documents are to be reviewed and in accordance with the implemented Change Control Program. Document changes require notification and related training. Change control records must include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective

3 Evaluation of suppliers, contractors, and consultants. Each manufacturer is required to establish and maintain the requirements, including quality requirements as well as a quality agreement that must be met by suppliers, contractors, and consultants. Each manufacturer is expected to:

1. Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation must be documented in accordance with cGMP/GDP
2. Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results
3. Establish and maintain records of acceptable suppliers, contractors, and consultants

4 How parties involved in the contract manufacturing of drugs or medical devices can utilize Quality Agreements to delineate their responsibilities and assure product quality, safety, and efficacy. This guidance applies to the commercial manufacturing of FDA regulated raw materials, final product components, intermediates, combination products or final products. For the purposes of generating the agreement, the term “manufacturing” includes processing, assembly, packing, holding, labeling operations, testing, and operations of the vendor’s Quality Unit

5 Purchasing data. Each manufacturer must establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received