ISO 13485:2016 Change? Do I Have To?? ©2016
11:00 am -12:00 pm – Session 2
“Transitioning to New EU MDR & EU IVDR”
• Linda Chatwin, Esq, RAC, Sr. Customer Solutions Consultant,
Health Sciences division - Emergo, a UL Company
• Michelle Bonn, President, Guideline Medical Consulting
• Adin Potter, Director, Corporate Compliance,
AngioDynamics
Regulatory Aspects and Basic Steps to Compliance: MDR and IVDR
Linda Chatwin, Esq, RACSr. Customer Solutions Consultant
Telephone: +1 360-817-5556
Email: [email protected]
Introduction of the Medical Devices Directive 93/42/EEC or commonly known as the MDD
Previously published was Active Implantable Medical Devices Directive 90/385/EEC or AIMDD
A few years later the In Vitro Diagnostic Directive 98/79/EC or IVDD
Major update to MDD and AIMDD by 2007/47/EC (Version 5 or M5) that had full implementation on March 2010
Major change was strengthening of clinical evaluation
23 Years …
• Oversight of notified bodies
• Post-market safety issues
• Transparency and traceability
• Access to external expertise
• IVD classification system
• Management of the EU regulatory system
• Control over non-European manufacturers
Weaknesses in existing medical device directives
No central marketing authorization
New regulation incorporates New Legislative Framework (economic operators)
Effects of PIP scandal in terms of reinforced post-market safety
Support for innovation and competitiveness among SMEs
Regulation (as opposed to Directive)
Evolution of the current EU regulatory regime
First section: Recitals (101)
Second Section: Chapters (I-X)• Legal framework and application of principles
• Application of the regulation including mandatory requirements
• Responsibilities of placing on market and monitoring
Third Section: Annexes (I- XVII)• Annex I Safety and Performance requirements
• Annex II-III technical documentation requirements
• Annex IV – V Declaration of Conformity and CE Marking
Structure of the Medical Device Regulation (MDR)
Third Section: Annexes (I- XVII), continued• Annex VI registration requirements and UDI
• Annex VII Notified Body requirements
• Annex VIII classification
• Annex IX – XI Conformity Assessment routes
• Annex XIII custom-made devices
• Annex XIV – XV clinical evaluation and clinical investigations
• Annex XVI list of non-medical products
• Annex XVII correlation table with the MDD
Structure of the Medical Device Regulation (MDR)
First Section: Recitals (101)
Second Section: Chapters (I-X)• Legal framework and application of principles
• Application of the regulation including mandatory requirements
• Responsibilities of placing on market and monitoring
Third Section: Annexes (I-XV)• Annex I Safety and Performance requirements
• Annex II-III Technical Documentation requirements
• Annex IV-V Declaration of Conformity and CE Marking
Structure of the In Vitro Diagnostic Device Regulation (IVDR)
Third Section: Annexes (I-XV), continued• Annex VI Registration requirements and UDI
• Annex VII Notified Body requirements
• Annex VIII Classification rules
• Annex IX – XI Conformity Assessment routes
• Annex XII Certificates issued by NBs
• Annex XIII Performance Evaluation, Performance Studies, Post-market Performance Follow-Up
• Annex XIV Interventional Clinical Performance Studies
• Annex XV Correlation table with the IVDD
Structure of the IVDR, continued
– More explicit requirements (per Annex XIV and XV)
– Database registration requirements
– Timeframes for Competent Authorities
– PMCF
Chapter VI: Clinical Evaluation and Clinical InvestigationsArticles 61 – 82
Chapter VII: Post-Market Surveillance, Vigilance and Market SurveillanceArticles 83 – 100
Dramatic change from manufacturer self-declared IVD (80%) to risk-based B/C/D classification with NB intervention
Positive listing
List A (Annex II) 3-5 % NB
List B (Annex II) 5-10 % NB
Self testing 5-10 % NB
other 70—80 %
Current IVDD
Risk classes
A 5-10 %
B 50 % NB
C 35 % NB
D 5-10 % NB
New IVDR
Risk
Change from Positive-Listing => Risk-based classes
– More explicit requirements (per Annex XIII and XIV)
– Database registration requirements
– Timeframes for Competent Authorities
– PMPF
Chapter VI – Clinical Evidence, Performance Evaluation and Performance StudiesArticles 56-77
Clinical evidence - demonstration
Performance Evaluation
Analytical performance data
Support intended purpose based on Performance Evaluation (Performance
Evaluation Plan, PER) and PMPF and PMS Plan
Clinical performance data
Scientific validity
• Clinical claims will need to be supported by data and specific reports depend risk of your device for all three pillars
• Clinical Evidence justified by data and conclusions
• Follow a performance evaluation plan (Article 56(1), Part A, Annex XIII)
• PER needed
• Notified Body will look into data AND methodology!
• Notified Body document results in Performance Evaluation Assessment Report (PEAR)
• Performance Study and Interventional Clinical Performance Study
Major changes
Chapter VII – Post-Market Surveillance, Vigilance and Market SurveillanceArticles 78 – 95
General Requirements in both Regulations
Technical documentation needs to be kept up to date
Record retention changed now 10 years (15 for implants)
QMS requirements (Art. 10)
Labeling provided in an official Union language
Much stronger emphasis on post market surveillance, incident reporting, field safety, and market withdrawals
Technical Documentation - MDR
Device must meet GSPR (Annex I): Article 5(2)• Including RM system Annex I, Section 1a (Article 10(2))
Technical documentation: Article 10(4)“Quality management system” Article 10(9)PMS system and PMCF: Article 10(10)Product liability introduced in Article 10 (16)Requirement to supply information to CA (Article 10 (14))Access to technical documentation (will end the Own Brand Label
manufacturer (Article 10(4)))
Manufacturer’s responsibilities - MDR
Use of harmonized standards (Article 8) published in OJEU
Common Specifications (CS) expected to be published (Article 9)
Requirements for manufacturers (Article 10)• Compliance to Annex I (GSPR)
• Technical documentation to Annex II
• Risk management process
• Performance evaluation process
• UDI
Technical Requirements for Products and General Manufacturer Obligations - IVDR
Eudamed is intended for transparency and traceability (Article 33)
Single Registration Number (SRN) for economic operators Article 31(2)
UDI for devices
SRN and UDI registered in Eudamed
Serious Incidents and Field Safety Corrective Action entered in Eudamed
Summary of Safety and Clinical Performance for Class III and implantable devices uploaded to Eudamed = FDA PMA Summary Article 32(1)
Parts of Eudamed will be public facing ! (Article 33(1))
UDI Database System and Eudamed
PMS system must be established defined by the manufacturer
PMS plans
Systematic method to gather relevant data
Applies to the entire product life-cycle – useful life of device and device end of life will be more significant
Periodic Safety Update Report (PSUR) required for Class IIa, IIb, and III updated annually (bi-annual for IIa); annually for Class C and D IVDs
Submitted electronically to the Notified Body
Post Market Surveillance (PMS) Requirements
Legislate MEDDEV 2.12/1
Serious incidents and field safety corrective action reported in a public electronic system (similar to MAUDE database)
Timeframe is similar: 2 days for serious public health threat, within 10 days for death/unanticipated serious deterioration state of health, and 15 days (reduced from 30) for serious incidents (not expressed as expected side-effects)
Even suspected incidents should be reported
FSCA handled timely by member states for further communication
Communicated back to the manufacturer
Notification to other Competent Authorities
Vigilance Activities and Reporting (Articles 87-92)
Monitor the incident rate and severity of incidents
Review the benefit-risk determination against data
Manufacturers must define statistical methods for analysis
Investigations must be performed without delay
Incidents will be evaluated against risk by the member states
Manufacturer must communicate updates which will be monitored by the Competent Authority
Field Safety Notification published without delay after review by the Competent Authority and/or Notified Body
Trending and Analysis of Incidents/Actions
New Central Body: MD Coordination Group (MDCG)
• Member state representatives
• Scrutiny procedure; Contribute to assessment of applicant notified bodies
• Develop guidance and coordinate of member stateso Clinical investigationo Vigilanceo Market surveillance
• Organized, supported and chaired by EU Commission
• May invite experts on case-by-case basis
• May establish subgroups, in which relevant stakeholders are observers
Relationship of Entities in EU
European Commission
European Parliament European Council
Competent Authorities
National Authorities
MDCG
Expert Panel
Notified Bodies
Manufacturers
Ethics Committee
Impact of Revised Medical Device Regulation
Clarification of many uncertainties from the past
Commission and Competent Authorities taking more responsibility and involvement
Approaching regulatory compliance from other countries – potential delays
More responsibilities for manufacturers and other economic operators
3 year transition will seem short in “real time” (5 year IVDR)
Prepare now for compliance activities
Higher Level of Regulatory Expectations
For Internal AngioDynamics Use Only29
Key Areas of Impact
• Detail of Technical Documentation• Compliance with common specifications• UDI • Eudamed database• Person responsible for regulatory compliance• Economic operators• Clinical evaluation• Clinical investigation for all implants and Class III, (unless device is
modification)
• Summary of safety and clinical performance (SSCP)• Post-market surveillance (PMS)
➢ Post-market clinical follow-up (PMCFU)➢ Vigilance
• Compliant Quality Management System• ISO 13485:2016 plus PMS
For Internal AngioDynamics Use Only30
Planning Steps
Based on first product registration date an overall project plan for implementation can be determine.
There Are Still Many Unknowns
Number of Notified Bodies
Eudamed
Clinical / Performance Evaluation Reports
Application of Risk Management
Unique Device Identification UDI
Conformity Assessment Schemes
Person Responsible for Regulatory Compliance
MDCG
Indications for use
Technical documentation
Clinical evidence
Equivalent devices (MDR)
Post-market surveillance
Product life-cycle
Unannounced audits
New and novel devices
Significantly Increased Areas of Scrutiny
Questions?Emergo can assist you in Europe and 23 other markets worldwide.
My contact information:
Linda ChatwinEMERGO | Sr. Customer Solutions [email protected]
EmergoGroup.com/resources/europe
ISO 13485:2016 Change? Do I Have To?? ©2016
11:00 am -12:00 pm – Session 2
“Transitioning to New EU MDR & EU IVDR”
• Linda Chatwin, Esq, RAC, Sr. Customer Solutions Consultant,
Health Sciences division - Emergo, a UL Company
• Michelle Bonn, President, Guideline Medical Consulting
• Adin Potter, Director, Corporate Compliance,
AngioDynamics
