Changing medical device regulations in Europe and the U.S.

Changing Regulations in
the EU and US
19th April 2016
London, UK

Introduction 3
Timelines 13
Reclassification 19
Reprocessing of Single Use Devices 21
Unique Device Identification (UDI) 23
Clinical Evidence 28
The Cost of Compliance 31
Questions 33
©2016 Maetrics. All Rights Reserved. 2
Presentation Topics

Introduction 3
Timelines 13
Reclassification 19
Questions 33
Presentation Topics

4
Introduction
 The most important change to the regulation of medical devices since CE marking was first
introduced
 Much is the same, or clarified
 Many important changes
 The new MDR is not news:
 First mooted as a Recast of the directive prior to 2007/47/EC
 Process became politicised following high profile adverse publicity for the industry
 PIP fraud using non-medical grade silicone, over a 16 year period
 MoM hip implants, vigilance failures
 Pelvic floor mesh issues
 Inconsistencies across Notified Bodies
 Modernise the CE marking legislation
 Improve patient safety
 Assisting innovation and trade across the EU
MDR Background
©2016 Maetrics. All Rights Reserved.

5
Introduction
 The future is now
 The future has already started
 Unannounced Inspections
 Clinical Evaluation Reports
 Joint audits of Notified Bodies by DA, CAs and FVO
 Reassessment of NBs by CA
 Other key topics
 Notified Body Capacity
 EN ISO 13485:2016
 OBL (on-site QMS audit; TF, Unannounced Inspections at OEM, no chains of OBL)
 Changes to EUAR liabilities, need for QP
 Compulsory Liability Insurance for Manufacturers
 Surveillance Fees in the UK
 Apprentice Levy (0.5% >250 employees)
 REACH / SVHC (168 substances limit to 0.1% w/w, at component level)
Not just changes within the MDR

6
Introduction
 The best companies will act early
 Notified Body capacity should be a major concern
 Wise to start planning now
 Nothing much will change, but anything can
 Learn the lessons from 2007/47/EC
Book early to avoid disappointment

7
Introduction
 2015 Data
 2082 company inspections
 Of whom, 797 companies received one or more 483s (38%)
 Totaling 1008 individual 483s
 Leading to 95 Warning Letters (4.5%)
 This is NOT probability it depends on your state of compliance
 Top 483 citations
US – Compliance Trends
Year #1 #2 #3 #4 #5
2015 CAPA Complaint
Files
Purchasing
Controls
Process Validation MDR
2014 CAPA Complaint
Files
Design
Controls
Purchasing Controls Receiving, In-Process,
Finished Device Acceptance
2013 CAPA Complaint
Files
Design
Controls
Receiving, In-Process,
Finished Device Acceptance
Purchasing Controls

8
Introduction
 FDA have plans to change from the current 25 district and regional offices managing
inspections to 3 offices for worldwide
 FDA have ‘Program Alignment Medical Devices and Radiological Health FY2016 Action Plan’
– see also http://www.fda.gov/AboutFDA/CentersOffices/ucm477082.htm
A. Transition to Commodity-Based and Vertically Integrated Regulatory Program (Specialization)
B. Training and Certification
C. Medical Devices and Radiological Health Program Work Planning
D. Quality Policy and Strategy
E. Imports
F. Laboratory Optimization
G. IT
US Issues

9
Introduction
 FDA are revising
 CPGM – Compliance Program Guidance Manuals
 IOM – Investigations Operations Manual
 QSIT approach is under review with potential to be replaced by MDSAP (Medical Device Single
Audit Plan) and within that context FDA has already announced plans to retire the voluntary ISO
13485 program in favour of MDSAP. Note: this is not a commitment at this time.
US Issues – Update of inspections Approach

10
Introduction
A. Transition to Commodity-Based and Vertically Integrated Regulatory Program (Specialization)
 More focussed approach
B. Training and Certification
 Many more highly trained resources, currently most inspectors have very general knowledge
C. Medical Devices and Radiological Health Program Work Planning
 Prioritise resources in line with the plan, and enforcement priorities
D. Quality Policy and Strategy
 FDA looking for 90% of their staff to have some connection with the public over the next 2 years to
understand the patients perspective
E. Imports
 More enforcement action on imports, especially Indian drugs hot topic
 Data integrity
 Increased foreign inspections. Proposals for increased funding, and headcount
F. Laboratory Optimization
 LDT – laboratory developed testing, validation and robustness
G. IT
 Focus on data integrity, documentation systems validation, altering of data
US Impact

11
Introduction
 No longer at an advantage during occasions where inspectors lack knowledge
 More and more Inspectors will be specialist and individually know more as a result of
extended training, e.g. electronics, software, 3D printing
 Training from Industry means specialists will be able to keep up with new manufacturing
methods and materials
 Efficiencies in filing times due to better skills set within FDA
 Conversely, will also be quicker action on compliance side, e.g. warning letters currently take
months, anticipated to be much quicker
US Impact

Introduction 3
Timelines 13
Reclassification 19
Questions 33
Presentation Topics

Timelines
 In the beginning
 Final MDR expected to Enter into Force in Q2/2014
 Always moving further away, but still ever closer
 Latest expectations are Entry into Force will be around Q4/2016
 Current status
 5th October 2015 – Council agreed a full “General Approach”. Trilogues began with the Council,
Parliament and Commission
 Luxembourgish presidency (July – December 2015) – 5 Trilogues, progress slower than hoped
 Dutch presidency (January – June 2016) – 3 Trilogues planned. Great expectations, for Q2/2016
 Slovakian presidency (July – December 2016) – Q4/2016?
 Malta presidency (January – June 2017)
 United Kingdom presidency (July – December 2017)
Timelines change frequently

Timelines
MDR - An early timeline
2012 2013 2014 2015 2016 2017
Draft MDR
Sept 2012
Amendments
agreed
Oct 2013
3 year transition period
Entry into
force
June 2014
Date of
Application
June 2017

Timelines
MDR - Current Timeline Estimate
2012 2013 2014 2015 2016 2017
Draft MDR
Sept 2012
Amendments
agreed
Sept 2016?
3 year transition period
Entry into
force
Dec 2016?
Date of
Application
Dec 2019?
2018 2019 2020
NBs can apply
+6 months for
re-designation

Timelines
 Entry into Force
 The date the MDR is published in the OJ
 The Date of Application
 3 years after Entry into Force
 6 months after Entry into Force, NBs may apply for Re-designation under the MDR
 Once granted NBs may begin to issue new certificates under the MDR and products may be legally
placed on the market under the new rules
 UDAMED database – timing remains unclear
 UDI requirements – timing remains unclear
 Total of 43 delegated acts that need to be implemented before the entire MDR can be fully
implemented
MDR - Entry info Force & Date of Application

Timelines
 The Date of Application is not necessarily the deadline
 No requirement that devices must be re-certified under the MDR by the Date Of Application of the
new Regulation
 Transitional provisions
 Certificates issued before to the entry into force of MDR stay valid for the period indicated on the
certificate
‒ Except certificates under Annex 4, Directive 90/385/EEC or Annex IV, Directive 93/42/EEC, which expire at the
latest 2 years after the Date Of Application
 Certificates issued during the 3-year transition period stay valid for the period indicated on the
certificate, BUT in any case will expire 4 years after the Date Of Application
 Devices placed on the market under the current MDD before the Date Of Application may
be made available for up to 4 years after that date
MDR - Certificate Validity (– but commercial pressures may apply)

Presentation Topics
Introduction 3
Timelines 13
Reclassification 19
Questions 33

Reclassification
 Classification rules are similar to before, but some significant examples of change:
 In vitro contact with cells/embryos going back into the body to be Class III (or IIa)
 Apheresis devices to be Class III
 IVF and ART non-invasive devices can be IIb
 Spinal implants to be Class III
 Total and partial joint replacements to be Class III
 Devices recording diagnostic images to be IIa
 Nanomaterial devices to be Class III
 AIMD accessories to be Class III
 Devices which are intended to be introduced into the human body via a body orifice, or applied on
skin and that are absorbed by or locally dispersed in the human body are to be Class III
 Reusable surgical Instruments are no longer class I
‒ (CAUTION) Rumour about Class I with NB input
Up-Classification of Devices

Introduction 3
Timelines 13
Reclassification 19
Questions 33
Presentation Topics

Reprocessing of Single Use Devices
 A sensitive subject for some, do these proposal enhance patient safety?
 Still under debate
 Allowed products list
 Banned products list Default is that it is allowed and manufacturers must state why not (European
Parliament)
 Re-processers become legal manufacturers
 Member States can control within their own borders
 In-house (i.e. hospitals) can continue to operate outside of the MDR
 Re-processers must confine activities to OEM once used product or their own re-processed
products
 Some debate over re-processing vs fully refurbished
Still Under Debate

Presentation Topics
Introduction 3
Timelines 13
Reclassification 19
Questions 33

23
Unique Device Identification (UDI)
UDI System (Article 24)
 Article 24: A single system for UDI shall be put in place in the Union
1. Basic requirements for the UDI system
2. Issuing agencies for UDIs in Europe
3. Assignment of UDIs
4. Placing of UDIs on device labels / how UDIs should be used
5. Recording of UDIs
6. UDI database
7. Delegated acts related to running the UDI system
8. External factors

24
Benefits of UDI
 To enhance the post-market safety of medical devices by:
 Improving incident reporting and recall processes
 Increased visibility for competent authorities
 Reducing the likelihood of product related errors
 Better stock-management by healthcare facilities
 Counterfeit devices

25
FDA
 UDI system – Final Rule 21 CFR Parts 16, 801 and 803
 Published September 2013
 Implements IMDRF UDI
 Timetable according to classification

26
Its not just a bar code!
 Requirements to record, and verify, UDI information on
 Complaints forms & records
 Adverse Incident / MDR forms & records
 Corrections & Removals forms & records
 DHR including QC Release forms & records
 Service forms & records
 Should have been implemented in 2013
 Unlikely to yield a 483 if UDI is not yet a requirement
 Should include a UPC (Universal Product code) if no UDI
 Includes UDI requirements as part of Design History

Presentation Topics
Introduction 3
Timelines 13
Reclassification 19
Questions 33

28
Clinical Evidence
Requirements
 Chapter 6 (12 articles)
 Clinical evaluation and clinical investigation
 Annex XIII: Clinical evaluation and PMCF
 Annex XIV: Clinical Investigations
 Clinical evidence
 Must justify the level of clinical evidence used (e.g. risk class, intended use, device characteristics, etc)
 Performance is not equivalence
 More data will be required, CERs already under greater scrutiny
 Greater expectation that clinical investigations will be required, especially for Class III devices
 Equivalence for Class III devices should not be from other manufacturers
 Clinical investigations
 Greater emphasis on patient safety
 Data robustness and protection of patients during clinical investigations

29
Clinical Evidence
Data Sources
Rule 8 Clinical data
 Clinical studies
 PMCF
 Scientific literature
 Engagement with KOLs
 Clinician and patient focus groups
 Registries
 Ongoing data sources
 Active post market surveillance, routed through Risk Management process
 Use error and feedback
 Complaints, vigilance reports and MDRs
 Ongoing research by legal manufacturer
 Competitor data

Presentation Topics
Introduction 3
Timelines 13
Reclassification 19
Questions 33

31
The Cost of Compliance
Its not going to get cheaper
Rule 8 MHRA surveillance fees
 Notified Body fees, including unannounced visits
 Punitive damages – regulators
 Compensation and punitive damages – courts and patients / patient groups
 Remediation projects
 Increased requirements
 CER
 Risk
 Up-classification
 New requirements
 UDI
 Person responsible for regulatory compliance
 Professional assistance

Presentation Topics
Introduction 3
Timelines 13
Reclassification 19
Questions 33

Maetrics
Maetrics Ltd Peter Rose
BioCity Nottingham Managing Director, Europe
Pennyfoot Street prose@maetrics.com
Nottingham +44 7811 199 346
NG1 1GF
United Kingdom
+44 115 921 6200
Contacts

Thank You!
34
The contents of this presentation are copyright ©2016 Maetrics. All rights reserved.
This presentation contains information in summary form and is intended for general
guidance only. It is not intended to be a substitute for detailed research or the exercise of
professional judgment. Maetrics cannot accept responsibility for loss occasioned to any
person, firm, company or corporation acting or refraining from action as a result of any
material in this publication. On any specific matter, reference should be made to the
appropriate professional advisor.

Changing medical device regulations in Europe and the U.S.

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