Medical Device Reporting (MDR) 2015

Key Topics

• 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
  • Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results
  • 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
  • Establish and maintain records of acceptable suppliers, contractors, and consultants
• 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).
  • 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
  • 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 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
• 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 product and services. Purchasing documents typically include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device
• 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
• Traceability - 820.65 - Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user are required to establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures are intended to facilitate corrective action. Such identification is to be documented in the DHR
• Identification - 820.60 - Each manufacturer must establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix ups
• CAPA - Before non-conformance or deviations are discovered, we also have to have an Incident Tracking system, which is used to determine when Corrective Action or Preventative Action needs to be applied - Quality Evaluation, Investigation, Root Cause Analysis, Change Management, Effectiveness Monitoring and Acceptance
• Control of nonconforming product. Each manufacturer must establish and maintain procedures to control product that does not conform to specified requirements. The procedures are required to address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance must include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation has to be documented
• Each manufacturer must maintain complaint files. Each manufacturer needs to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit
• Each manufacturer is required to maintain a quality system record (QSR) for each batch or lot. The QSR will include, or refer to the location of, procedures and the documentation of activities required for the production of the product that are not specific to a particular type of device(s), including, but not limited to, the records required by 820.20. Each manufacturer is required to ensure that the QSR is prepared and approved in accordance with 820.40 as well as the Quality Review documentation used for release

Who should Attend

Quality Assurance (QA) and Operations Management from medical device companies.