Slide 1 of 20 Rob Packard, President [email protected] FRM-023 A D1 – Management Review Template Management Review Management

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Rob Packard, Presidentwww.MedicalDeviceAcademy.com

[email protected]

FRM-023 A D1 – Management Review Template

Management ReviewManagement Representative: First Last

Date: February 4, 2015Location: Misc. Conference Room

http://www.medicaldeviceacademy.com/


mailto:[email protected]

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Management Review Agenda• Roll Call of Attendees (5.6.1)• Suitability of Quality Policy (5.3e)• Status of Quality Objectives (5.4.1)• Results of Audits: 1st party, 2nd party , 3rd party and FDA inspections (5.6.2a)• Customer Feedback (5.6.2b)• Process Performance (5.6.2c)• Product Conformity (5.6.2c)• Supplier Quality Performance (Clause 8.4)• Status of Corrective and Preventive Actions (5.6.2d)• Follow-up Actions from Previous Management Reviews (5.6.2e)• Changes that Could Affect the QMS (5.6.2f)• Recommendations for Improvement (5.6.2g)• New or Revised Regulatory Requirements (5.6.2h)• Risk Management Process Effectiveness (3.2 in EN ISO 14971:2012)• Overall Quality System Effectiveness (5.1)• Improvements Needed to Maintain QMS Effectiveness (5.6.3a)• Improvement of Product Related to Customer Requirements (5.6.3b)• Resource Needs (5.6.3c)




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Roll Call of Attendees (5.6.1)




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Suitability of Quality Policy (5.3e)




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Status of Quality Objectives (5.4.1)




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Results of Audits (5.6.2a)




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Customer Feedback (5.6.2b)




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Process Performance (5.6.2c)




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Product Conformity (5.6.2c)




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Supplier Quality Performance (Clause 8.4)




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Status of Corrective and Preventive Actions (5.6.2d)




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Follow-up Actions from Previous Management Reviews (5.6.2e)




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Changes that Could Affect the QMS (5.6.2f)




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Recommendations for Improvement (5.6.2g)




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Previous Changes Not Fully Implemented by FDA (5.6.2h)

• UDI Final Rule – Implementation Deadlines started in 2014 and end in 2017; http://bit.ly/UDI-ComplianceDates; this will be globally compatible

• 21 CFR 803 was updated to require electronic submission of MDRs by manufacturers; implementation deadline is August 14, 2015; http://bit.ly/udpated-21CFR803




http://bit.ly/UDI-ComplianceDates

http://bit.ly/UDI-ComplianceDates

http://bit.ly/udpated-21CFR803

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10 New FDA Final Guidance (5.6.2h)• New Final Guidance Released in Q4:

– Doc # 1810, Minimizing Risk for Children's Toy Laser Products - Guidance for Industry and Food and Drug Administration Staff

– Doc # 1685, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff

– Doc # 1694, Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff

– Doc # 1768, Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex - Guidance for Industry and Food and Drug Administration Staff

– Doc # 1400052, Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff




http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM363731

















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10 New FDA Final Guidance (5.6.2h)

• More New Final Guidance Released in Q4:– Doc # 1750,

Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff

– Doc # 1763, Molecular Diagnostic Instruments with Combined Functions - Guidance for Industry and Food and Drug Administration Staff

– Doc # 1400019, Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex and Genetic Mutations Associated with Mycobacterium tuberculosis Complex Antibiotic Resistance in Respiratory Specimens - Guideline for Industry and Food and Drug Administration Staff

– Doc # 1819, Distinguishing Medical Device Recalls from Medical Device Enhancements - Guidance for Industry and Food and Drug Administration Staff

– Doc # 1825, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff























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5 New Draft FDA Guidance (5.6.2h)• New Draft Guidance Released in Q4:

– Doc # 1400045, Radiation Biodosimetry Devices - Draft Guidance for Industry and Food and Drug Administration Staff

– Doc # 1808, Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers Draft Guidance for Industry and Food and Drug Administration Staff

– Doc # 1787, Flow Cytometric Devices - Draft Guidance for Industry and Food and Drug Administration Staff

– Doc # 1739, Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

– Doc # 1738, Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)























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US New & Revised Regulatory Requirements (5.6.2h)

• FDA released FY 2015 proposed guidance development list on 1/8/2015 - http://bit.ly/FY2015-Proposed-FDA-guidance

• Note: this slide deck is not product or company-specific. Therefore, you should also review updates specific to your product(s) at the following links:

• Recognized standards (http://bit.ly/Recognized-Consensus-Standards),

• Device classifications (http://bit.ly/ProductClassification), and

• Total Product Lifecycle (TPLC) database (http://bit.ly/FDA-TPLC).




http://bit.ly/FY2015-Proposed-FDA-guidance

http://bit.ly/Recognized-Consensus-Standards

http://bit.ly/ProductClassification

http://bit.ly/FDA-TPLC

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EU New & Revised Regulatory Requirements (5.6.2h)

• MEDDEV 2.12/1 rev. 8; Guidelines on a Medical Devices Vigilance System - most recent revision to EU Guidance documents in January 2013

• Rev 8 forms for vigilance were dropped and Rev 7 is still valid

• No new consensus statements or interpretive documents• The Notified Body Recommendation Group (NBRG)

released a draft of a consensus paper related to the Z annexes for EN ISO 14971:2012 on June 25 of last year. You can download the draft document at the following link: http://bit.ly/Consensus-Draft-14971. The draft is still not approved by the NBRG.




http://bit.ly/Consensus-Draft-14971



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EU New & Revised Regulatory Requirements (5.6.2h)

• Proposed EU Medical Device Regulations (EMDR) were modified by ENVI Committee and Parliament, but waiting for EU Council to provide input; new EMDR expected in 2016 with 3-year transition

• Europa website recently changed many pages; More frequent review of updates may be needed in 2015

• Events Calendar of EU Commission meetings was posted: http://bit.ly/EUEvents2015




http://bit.ly/EUEvents2015

http://bit.ly/EUEvents2015

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Canadian New & Revised Regulatory Requirements (5.6.2h)

• The CMDR indicates that it is current to December 22, 2014; however, the last amendment was December 16, 2011 (i.e., no significant changes).

• New draft regulation, October 20, 2014: Draft Guidance Document - Guidance for the Labelling of Medical Devices, Not Including In Vitro Diagnostic Devices - Appendices for the Labelling of Soft Contact Lenses, Decorative Contact Lenses, and Menstrual Tampons

• Fees are update on April 1, 2015• MDSAP Pilot has begun. Health Canada intends to

replace CMDCAS program with MDSAP in 2017. Only recognized registrars are eligible for MDSAP pilot.




http://www.hc-sc.gc.ca/dhp-mps/consultation/md-im/labl_etq_dv10_draft_ebauche-eng.php





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Risk Management Process Effectiveness (ISO 14971)




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Overall QMS Effectiveness (5.1)




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Improvements Needed to Maintain QMS Effectiveness (5.6.3a)




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Improvement of Product Related to Customer Requirements (5.6.3b)




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Resource Needs (5.6.3c)


