Medical Device Reporting (MDR)

Date: Thursday, August

20th, 2015 || Time: 01:00 PM EDT | 10:00 AM PST

Duration: 90 Minutes || Course Level: Intermediate

'Live' Webinar by Jerry

Dalfors

Register Now

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 webinar
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 FDAs 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 vendors 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 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

6 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
7 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
8 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
9 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
10 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
11 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. Such procedures are intended to ensure that:
1. All complaints are processed in a uniform and timely manner;
2. Oral complaints are documented upon receipt; and
3. Complaints are evaluated to determine whether the complaint represents an event
which is required to be reported to FDA under part 803 of this chapter, Medical Device
Reporting
4. Must have a good definition of a complaint, not just patient questions regarding
technical use

Learning objective
Each year, the FDA receives several hundred thousand medical device reports of
suspected device-associated deaths, serious injuries and malfunctions. Medical Device
Reporting (MDR) is one of the post market surveillance tools the FDA uses to monitor
device performance, detect potential device-related safety issues, and contribute to
benefit-risk assessments of medical devices.
Device Manufacturers are required to submit certain types of reports for adverse events
and product problems to the FDA in a very short time about identified problems with a
medical device. If you are a manufacturer, you are considered to have become aware of
an event when any of your employees becomes aware of a reportable event that is
required to be reported within 30 calendar days or that is required to be reported within 5
work days because the FDA requested reports in accordance with 803.53(b)s
Who will benefit

Quality Assurance (QA) Professionals

Operations Management Professionals
Medical Device distributors
Consumers, Patients
Compliance Officers
Health Information Managers
Legal Counsel
Data and Device Standards experts
CIO/CFO/CTO
Audit/Inspection coordinators, internal auditors
IT / IS managers and personnel
Consultants and Strategists

Speaker profile
Jerry Dalfors has extensive (40+ years) of business administration,
consultative, technical and managerial experience in the development and
manufacture of highly regulated biopharmaceutical products including
injectables, biologics, medical devices and oral dosages. He has held permanent
employee, temporary employee and company representative management positions with
a multitude of the major pharmaceutical and biotechnology companies in the US. He has
worked with or assisted more than two dozen companies with the establishment of
controlled document/quality systems, FDA briefing and submittal documents, project
management of several multimillion dollar projects including design, start-up and
validation to assure fast track FDA approval by maintaining strict regulatory compliance
during all phases of engineering, construction, commissioning and validation, and has
written numerous submission documents for product, process and facility

approval/licensing which also required the development of quality systems which

included customer complaint management, deviation management, CAPA and
associated site wide employee training. Each of his projects have been received and
accepted by the FDA and other regulatory agencies. Jerry is considered an expert in
most all aspects of the biopharmaceutical and medical device industry and has trained
many FDA field inspectors on a variety of topics. None of his work has ever received a
483 but has corrected and prevented many along with Warning Letter remediation.