MDSAP Presentation
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The document discusses upcoming changes to regulatory requirements for medical devices, including: 1) The MDSAP program which allows a single audit to satisfy multiple regulators like FDA, EU, Japan, Australia. Major auditing organizations have been recognized to conduct MDSAP audits. 2) Revisions to ISO 13485:2016 including greater risk focus, regulatory linkage, and design/development changes. Manufacturers must transition to the new standard by March 2019. 3) Changes to the MEDDEV 2.7.1 clinical evaluation guidance including more frequent evaluations based on risk class and new requirements for team qualifications and establishing state of the art. 4) The upcoming EU Medical Device Regulation which replaces the Medical
MDSAP Presentation
- 1. MDSAP/EU MD Changes PharMed Management Group Inc. Rita Shahvar
- 2. AGENDA • MDSAP • ISO 13485:2016 • Clinical Evidence Report – MEDDEV 2.7.1/Rev 4 • Medical Device Directive – Revisions (MDR) • PharMed Management Group Can Help.
- 3. MDSAP – Auditing Organization with Recognition • The following auditing organizations have received authorization to conduct MDSAP audits and have recognition from FDA to perform audits accepted in the US, EU, JP, AUS and others harmonized geographies. • BSi Group America Inc. • Intertek Testing Services NA Inc. • TÜV SUD America Inc.
- 4. MDSAP – Audit Requirements • MDSAP is a single audit program that will allow a single regulatory audit to satisfy the needs of multiple regulatory jurisdictions. • The single audit of a medical device manufacturer’s quality management system will include the assessment of design and development (where appropriate), Good Manufacturing Practices (GMPs), adverse event reporting, and other applicable requirements of the participating regulatory authorities. • Auditors followed published MDSAP audit guidance very closely. MDSAP certificates for all ISO 13485/CMDCAS locations when MDSAP becomes fully operational in 2017.
- 5. MDSAP – Partners in the MDSAP Pilot Program • The MDSAP Pilot is intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program. • International partners that are participating in the MDSAP Pilot include: • Therapeutic Goods Administration of Australia • Brazil’s Agência Nacional de Vigilância Sanitária • Health Canada • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
- 6. AGENDA • MDSAP • ISO 13485:2016 • Clinical Evidence Report – MEDDEV 2.7.1/Rev 4 • Medical Device Directive – Revisions (MDR) • PharMed Management Group Can Help.
- 7. ISO 13485:2016 – Changes from 2003 • Some of the biggest changes between the 2003 and 2016 version include: • Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements; • Increased linkage with regulatory requirements, particularly for regulatory documentation; • Application to organizations throughout the lifecycle and supply chain for medical devices; • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard; • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties; • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records; • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance; and • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay.
- 8. ISO 13485:2016 – Changes from 2003 • Advance planning is essential to avoid panic closer to March 2019. • Health Canada has announced that as of 1 January 2019, they will terminate their current CMDCAS program and only accept MDSAP certificates. Manufacturers with products on the market in Canada cannot wait until 29 February 2019 to transition to the ISO 13485:2016 certificate. Failure to meet the 1 January 2019 date for transition to a MDSAP certificate may mean your products will not be licensed in Canada1 1. https://www.bsigroup.com/en-US/medical-devices/Our-services/ISO-13485-Revision/ 1
- 9. AGENDA • MDSAP • ISO 13485:2016 • Clinical Evidence Report – MEDDEV 2.7.1/Rev 4 • Medical Device Directive – Revisions (MDR) • PharMed Management Group Can Help.
- 10. MEDDEV 2.7.1./4 – Clinical Evaluation • Majority of Revision 3 is the same with the exception of details regarding: • Frequency of Evaluation • Low Risk (Class I) – 2 to 5 years • Low-Medium Risk (Class IIa) - at least every two (2) years • Medium Risk (Class IIb) – at least annually • High Risk/Implantable Devices – Annually • Qualifications of Team Members • Declaration of Interest • Intended to prevent bias • Establishing State-of-the-Art • Equivalency • A contract to be made between internal organization and equivalent manufacturer allowing access to their data on an ongoing basis. • If this is not feasible, manufacturers should at least provide physical, mechanical and chemical characterization requirements through comparative testing.
- 11. AGENDA • MDSAP • ISO 13485:2016 • Clinical Evidence Report – MEDDEV 2.7.1/Rev 4 • Medical Device Directive – Revisions (MDR) • PharMed Management Group Can Help.
- 12. Medical Device Directive Revision - MDR • The new rules will apply 3 years after publication for medical devices. • ISO 13485:2016 was published in March 2016, with a transition period of three years. The harmonization of this standard allows the presumption of conformity to the Regulation in the future. • Manufacturers will have the transition period to apply for certification under the MDR for devices currently certified under the Medical Devices Directive (MDD). Certificates issued to the • MDD during the transition period will remain valid for the entirety of their certification period (no longer than five years), unless that exceeds four years after the date of application. If you do not receive certification during the transition period, and your MDD certificate expires, you will have to remove products from the market in the EU until they have been certified under the MDR. http://www.aami.org/productspublications/articledetail.aspx?ItemNumber=3189
- 13. AGENDA • MDSAP • ISO 13485:2016 • Clinical Evidence Report – MEDDEV 2.7.1/Rev 4 • Medical Device Directive – Revisions (MDR) • PharMed Management Group Can Help.
- 14. PharMed Management Group Can Help. • Gap Assessments for current quality system per the requirements required for MDSAP. • Align requirements for MDSAP and revised ISO 13485:2016 to identify processes that should be updated to meet harmonized requirements. • Update procedure for CER per MEDDEV 2.7.1/4 requirements and develop a gold standard template to meet requirements for rev 4, and risk based classification of products. • Perform a preparedness audit for MDSAP, MDR and ISO 13485:2016. • Revised CER’s to meet MEDDEV 2.7.1/4 requirements using revised template. • MDR gap assessment, based on anticipated changes to be implemented after May 2017, and final version of Medical Device Directive Revision (MDR) is issued. • Please contact us at pharmedgrp@gmail.com or 847-947-0560.