1. WELCOME ISO 13485:2016 & MDR

2. Susan Murphy European Medical Device Operations Manager
ISO 13485:2016 Are you ready?
Susan Murphy
European Medical Device Operations Manager

6. So…Where Are We Now?

7. Definitions
Shall
Used to express a command or exhortation you shall go
Used in laws, regulations, or directives to express what is mandatory <it shall be unlawful to carry firearms
You shall do as I say

8. Definitions Will Used to express desire choice willingness consent
or in negative constructions refusal

9. Present (*Most of the World)
ISO 13485:2003:
Medical Devices – Quality Management Systems,
Requirements For Regulatory Purposes

10. Present – Europe (*Harmonized EU Version)
EN ISO 13485:2012: Medical Devices – Quality Management Systems – Requirements For Regulatory Purposes

11. Future Published as an ISO Standard on March 1st 2016
Effective 1st March ISO 13485:2003 certificates will no longer be issued, modified or revised by NSAI
Effective 1st March 2019 all 13485:2003 certificates will become invalid
Effective until 1st March 2018 any new, modified or revised ISO 13485:2003 certificates issued by NSAI will have an expiry date not to exceed 1st March 2019

12. Harmonisation
Once published, ISO 13485:2016 will still need to be reviewed, accepted, and voted on for Harmonization in the EU.
Only EU Harmonized Standards are recognized for “presumed compliance” with EU Medical Directive requirements (e.g. EN ISO 13485:2016 for CE Marking)

13. What’s New In 2016? 0.1 Introduction - General
The standard “can be used by an organization involved in one or more stages of the life-cycle of a medical device”
And, by suppliers and other external parties providing product to such organizations.

14. What’s New In 2016? Section 1 – Scope
1.1 - This International Standard can also be used by suppliers or external parties that provide product including quality management system-related services to such organizations.
1.2 - Any requirement of Clause 6, 7, or 8 can be deemed “not applicable” to the organization (with documented justification).

15. What’s New In 2016? Section 1.2 – Scope
“risk” = pertains to safety and performance requirements, or meeting regulatory requirements
“documented”= required to be established, implemented, and maintained
“Product” = now means product or service… output that is intended for a customer, or… an intended output of Product Realization
“regulatory requirements” = is limited to the legal requirements for the quality management system and legal requirements for safety or performance of the device

16. What’s New In 2016? Section 1.2 – Scope
“The processes required by this International Standard that are applicable to the organization, but are not performed by the organization,
are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.”

17. What’s New In 2016? Section 4: Quality Management System
4.1 General
4.1.1 document the role(s) of the organization.
4.1.2 determine and apply the processes needed and apply a risk based approach to the control of those processes
4.1.4 Changes made to these processes must be:
Evaluated for impact on the QMS
Evaluated for impact on the medical device produced
Controlled

18. What’s New In 2016? Section 4: Quality Management System
4.1 – General (software):
4.1.6 – Requires documented procedures for the validation of software used in the Quality Management System.
4.1.6 – Such software shall be validated prior to initial use, and as appropriate, after changes.

19. What’s New In 2016? Section 4: Quality Management System
* Medical Device File:
For each medical device type or medical device family, the organization shall establish and maintain a file(s) either containing or referencing documents generated to demonstrate conformity with the requirement of this International Standard and compliance with applicable regulatory requirements. The content shall include, but is not limited to…. (New sub-clause)

20. What’s New In 2016? Section 4: Quality Management System
(4.2.3) Medical Device File Content:
General description of the medical device, intended use/purpose, and labelling, including any instructions for use;
Specifications for product,
Specifications or procedures for manufacturing, packaging, storage, handling and distribution;
Procedures for measuring and monitoring;
As appropriate, requirements for installation; and
As appropriate, procedures for servicing.
(*New)

21. What’s New In 2016? Section 5: Management Responsibility
5.6 – Management Reviews
The organization shall document procedures for management review
The organization shall carry out management review at documented planned intervals
New management review inputs
Complaint handling
Reporting to regulatory authorities

22. What’s New In 2016? Section 5: Management Responsibility
New management review inputs
Complaint handling
Reporting to regulatory authorities

23. What’s New In 2016? Section 5: Management Responsibility
New Management review outputs
All outputs shall be recorded and include the inputs reviewed and decisions in relation to
Suitability, adequacy and effectiveness of the system
Changes needed to respond to new and or revised regulatory requirements

24. What’s New In 2016? Section 6: Resource Management
Demonstrating and maintaining competence
Infrastructure prevent product mix-up and ensure orderly handling of product.

25. What’s New In 2016? Section 6: Resource Management
*6.4.2 – Contamination Control
control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product.
For sterile medical devices, the organization shall document requirements for control of contamination with micro-organisms or particulate matter and maintain the required cleanliness during assembly or packaging processes. (*New sub-clause)

26. What’s New In 2016? Section 7: Product Realization
7.1 – Product Planning
(c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance

27. What’s New In 2016? Section 7: Product Realization
7.2.1 – Determination of Product Requirements
d) any user training needed to ensure specified performance and safe use of the medical device;

28. What’s New In 2016? Section 7: Product Realization
7.2.2 – Review of Requirements related to the product:
c) applicable regulatory requirements are met,
d) any user training identified in accordance with is available or planned to be available,..

29. What’s New In 2016? Section 7: Product Realization
7.2.3 – Communication:
The organization shall communicate with regulatory authorities in accordance with applicable regulatory requirements.

30. What’s New In 2016? Section 7.3: Design and Development
7.3.2 – Design and Development Planning
design and development planning documents shall be maintained and updated as the design and development progresses
the methods to ensure traceability of design and development outputs to design and development inputs; and
the resources needed including necessary competence of personnel
Inputs shall include usability and
The requirements for the design and development of the product and processes.

31. What’s New In 2016? Section 7.3: Design and Development
7.3.5 – Design and Development Review
Shall include the identification of the design under review, the participants involved and the date of the review

32. What’s New In 2016? Section 7.3: Design and Development
7.3.6 – Design and Development Verification
The organisation shall
Document verification plans, including acceptance criteria, statistical techniques and rational for sample size
Where a device is connected to another device, verification shall include confirmation that the design output meets the design input when connected

33. What’s New In 2016? Section 7.3: Design and Development
7.3.7 – Design and Development Validation
The organisation shall
Document validation plans, including acceptance criteria, statistical techniques and rational for sample size
Validation shall be conducted on representative samples. The rational for product choice shall be recorded
Where a device is connected to another device, validation shall include confirmation that the requirements for the specified application or intended use have been met
a medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer
Validation shall be completed prior to release for use of the product to the customer.

34. What’s New In 2016? Section 7.3: Design and Development
*7.3.8 – Design and Development Transfer
The organization shall document procedures for transfer of design and development outputs to manufacturing.
Results and conclusions of the transfer shall be recorded (see 4.2.5).
(*New sub-clause)

35. What’s New In 2016? Section 7.3: Design and Development
7.3.9 – Control of Design and Development Changes
The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use
the changes shall be:
reviewed;
verified;
validated, as appropriate; and
approved.

36. What’s New In 2016? Section 7.3: Design and Development
7.3.9 – Control of Design and Development Changes (cont’d)
The review of design and development changes shall include
evaluation of the effect of the changes on constituent parts and product in process or already delivered,
inputs or outputs of risk management and product realization processes.

37. What’s New In 2016? Section 7.3: Design and Development
* – Design and Development Files
The organization shall maintain a design and development file for each medical device type or medical device family.
This file shall include or reference records generated to demonstrate conformity to the requirements for design and development
and records for design and development changes.
(*New sub-clause)

38. What’s New In 2016? Section 7.4: Purchasing
7.4.1 – Purchasing Process
The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be:
based on the supplier’s ability to provide product that meets the organizations’ requirements,
based on the performance of the supplier,
based on the effect of the purchased product on the quality of the medical device, and
proportionate to the risk associated with the medical device.

39. What’s New In 2016? Section 7.4: Purchasing
7.4.1 – Purchasing Process (cont’d)
The organization shall plan the monitoring and re-evaluation of suppliers
Nonfulfillment of purchasing requirements shall be addressed with the supplier proportionate to the risk associated with the purchased product and compliance with applicable regulatory requirements.

40. What’s New In 2016? Section 7.4: Purchasing
7.4.3 – Verification of Purchased Product
The extent of verification activities shall be based on the supplier evaluation results and proportionate to the risks associated with the purchased product.
When the organization becomes aware of any changes to the purchased product, the organization shall determine whether these changes affect the product realization process or the medical device.

41. What’s New In 2016? Section 7.5: Production & Service Provision
– Control of Production…
As appropriate, production controls shall include but are not limited to:
b) qualification of infrastructure,
c) implementation of monitoring and measurement of process parameters and product characteristics

42. What’s New In 2016? Section 7.5: Production & Service Provision
7.5.2 – Cleanliness of Product
The organization shall document requirements for cleanliness of product or contamination control of product if:
c) product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use;

43. What’s New In 2016? Section 7.5: Production & Service Provision
7.5.4 – Servicing Activities
The organization shall analyze records of servicing activities carried out by the organization or its supplier:
to determine if the information is to be handled as a complaint and
as appropriate, for input to the improvement process

44. What’s New In 2016? Section 7.5: Production & Service Provision
7.5.6 – Validation of Processes (cont’d)
as appropriate, statistical techniques with rationale for sample sizes
requirements for records (see 4.2.5);
revalidation, including criteria for revalidation; and
approval of changes to the processes

45. What’s New In 2016? Section 7.5: Production & Service Provision
7.5.6 – Validation of Processes (cont’d)
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software including the effect on the ability of the product to conform to specifications.
Records of the results and conclusion of validation and necessary actions from the validation shall be maintained (see and 4.2.5).

46. What’s New In 2016? Section 7.5: Production & Service Provision
7.5.7 Particular Requirements for the Validation of Process of Sterilization and Sterile Barrier Systems
The organization shall document procedures (see 4.2.4) for the validation of processes for sterilization and sterile barrier systems.
Processes for sterilization and sterile barrier systems shall be validated prior to implementation and following product or process changes, as appropriate.
Records of the results and, conclusion of validation and necessary actions from the validation shall be maintained

47. What’s New In 2016? Section 7.5: Production & Service Provision
7.5.8 – Identification
The organization shall identify product status with respect to monitoring and measurement requirements throughout product realization. Identification of product status shall be maintained throughout production, storage, installation and servicing of product to ensure that only product that has passed the required inspections and tests or released under an authorized concession is dispatched, used or installed. (*was previously sub-clause )
If required by applicable regulatory requirements, the organization shall document a system to assign unique device identification to the medical device.

48. What’s New In 2016? Section 7.5: Production & Service Provision
– Preservation of Product
The organization shall protect product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution by:
designing and constructing suitable packaging and shipping containers, or
documenting requirements for special conditions needed if packaging alone cannot provide preservation

49. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
8.2.1 – Feedback
This feedback process shall include provisions to gather data from production as well as post-production activities

50. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
*8.2.2 – Complaint Handling
The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements.
These procedures shall include at a minimum requirements and responsibilities for:
receiving and recording information,
evaluating information to determine if the feedback constitutes a complaint,
investigating complaints,
determining the need to report the information to the appropriate regulatory authorities,
handling of complaint-related product, and
determining the need to initiate corrections or corrective actions.

51. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
*8.2.2 – Complaint Handling (cont’d)
If any complaint is not investigated, justification shall be documented. Any correction or corrective action resulting from the complaint handling process shall be documented.
If an investigation determines activities outside the organization contributed to the complaint, relevant information shall be exchanged between the organization and the external party involved.
Complaint handling records shall be maintained (see 4.2.5).
(new sub clause)

52. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
*8.2.3 – Reporting to Regulatory Authorities
If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, the organization shall document procedures for providing notification to the appropriate regulatory authorities.
Records of reporting to regulatory authorities shall be maintained (see 4.2.5).
(*NEW sub-clause)

53. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
8.2.6 – Monitoring and Measuring of Product
records shall identify the test equipment used to perform measurement activities.

54. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
*8.3.1 – General
The evaluation of nonconformity shall include a determination of the need for an investigation and notification of any external party responsible for the nonconformity.
*8.3.2 –
Actions in response to nonconforming product detected before delivery
Records of actions relating to the issuance of advisory notices shall be maintained
(*New sub-clause)

55. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
If the analysis of data shows that the quality management system is not suitable, adequate or effective, the organization shall use this analysis as input for improvement as required in 8.5

56. What’s New In 2016? Section 8: Measurement, Analysis and Improvement
8.5.2 – Corrective Action
verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
8.5.3 – Preventive Action
verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;

57. NSAI Technical Questionnaire
What’s New In 2016?
GCL-25-01
NSAI Technical Questionnaire

58. MDR: Major Changes and Impact on Industry
Colm O’Rourke
NSAI- Medical Devices
@NSAI_Medical

59. What we will cover Current status and NB designation plan
Why we got to where we are
Outcome of investigations
What is a Notified Body and how do we work
MDR content and changes
Industry/Market impact
Wrap up

60. Charles Darwin

61. Current status & NB designation plan
MDR not officially published
3 year transition period from date of official publication
Notified Body re-designation likely an 18 month process
Publication in OJ
6-12 month provisions
Full application of MDR
Existing certs void 4 years from full application of the MDR

62. Why is it all changing?
Directive Regulation

63. Outcome of investigations by FVO and Joint Commission80
Notified Bodies 56

64. What is a Notified Body?
NSAI
BSI
TUV
SGS
LNE G/MED
LRQA
DEKRA

65. MDR (Medical Device Regulation) – What is it?
More detailed requirements on everything: previous MD Directive 60+ pages vs. new regulation of 566 pages
It will greatly change how approval for products is sought and maintained (CE–mark)

66. MDR – Software as a medical device
Much more focus
Life cycle development
Classification

67. MDR – Grandfathering Established product must comply
What standards were used in product development?
Was a clinical trial carried out?
Will there be market supply issues?

68. MDR – Equivalence Level of access to predicate data Contract in place?
Disproportionately effect start-ups/smaller companies
Will this reduce the number of new products?

69. MDR – Classification Some devices will be up classified
Some products named specifically: breast implants, hip replacements, meshes
Expert panel – increased time to market
Act now to check if your classification will change

70. MDR – Notified Bodies Increased pressure from CA
Stricter competency requirements
Overall capacity squeeze

71. MDR – Other areas of interest
Clinical data requirements
Common Specifications
UDI
Person Responsible
Revised Economic Operator roles
General safety and performance requirements
Cosmetic devices/Devices without an indented medical purpose
EUDAMED
Additional reports required: PSUR/SSCP
Unannounced audits: MDR states at least once every 5 years

72. Industry/Market impact
New product development
Increased risk management requirements
Time to Market
Clinical data
Approval process
Post market surveillance
Overall resource drain
Getting and maintaining compliance
Remediation of existing products
Removal of non-compliant products

73. Wrap up
NSAI is here to help

74. Colm O’Rourke
NSAI- Medical Devices
@NSAI_Medical

75. Questions?