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

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.