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Changing Regulations in the EU and US19th April 2016London, UK
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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
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Presentation Topics
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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
Presentation Topics
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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
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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
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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
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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
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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
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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
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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
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Introduction
A. Transition to Commodity-Based and Vertically Integrated Regulatory Program (Specialization)
More focussed approachB. Training and Certification
Many more highly trained resources, currently most inspectors have very general knowledgeC. Medical Devices and Radiological Health Program Work Planning
Prioritise resources in line with the plan, and enforcement prioritiesD. 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
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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
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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
Presentation Topics
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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
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Timelines
MDR - An early timeline
2012 2013 2014 2015 2016 2017
Draft MDRSept 2012
Amendments agreed
Oct 2013
3 year transition period
Entry into force
June 2014
Date of Application June 2017
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Timelines
MDR - Current Timeline Estimate
2012 2013 2014 2015 2016 2017
Draft MDRSept 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
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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
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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)
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Presentation Topics
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
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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
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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
Presentation Topics
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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
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Presentation Topics
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
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Unique Device Identification (UDI)
UDI System (Article 24)
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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
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Unique Device Identification (UDI)
Benefits of UDI
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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
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Unique Device Identification (UDI)
FDA
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UDI system – Final Rule 21 CFR Parts 16, 801 and 803
Published September 2013
Implements IMDRF UDI
Timetable according to classification
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Unique Device Identification (UDI)
Its not just a bar code!
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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
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Presentation Topics
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
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Clinical Evidence
Requirements
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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
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Clinical Evidence
Data Sources
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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
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Presentation Topics
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
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The Cost of Compliance
Its not going to get cheaper
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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
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Presentation Topics
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
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Maetrics
Maetrics Ltd Peter RoseBioCity Nottingham Managing Director, EuropePennyfoot Street [email protected] +44 7811 199 346NG1 1GFUnited Kingdom
+44 115 921 6200
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Contacts
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Thank You!
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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.
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