Proposed changes to medical device legislation in Europe

Proposed Changes to Medical Device Legislation in Europe

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Proposed changes to medical device legislation in Europe

Key Issues
Identified weaknesses of current EU Directives Evolution of EC approach Proposed Regulations Transparency and Traceability Oversight of Notified Bodies Classification Conformity Clinical Evaluation and Investigation Vigilance and Market Surveillance Management of Regulatory System Conclusions
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Proposed changes to medical device legislation in Europe

Current Events
Notified Body (NB) Code of Conduct, vers. 3.0, 10 October 2012 EU Commissions PIP Action Plan: EU Commission Regulation Designation for NB Supervision EU Commission Recommendations for Audits and Assessments
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Proposed changes to medical device legislation in Europe

Weaknesses in Existing Medical Device Directives

Oversight of Notified Bodies Post-market safety issues Transparency and traceability Access to external expertise Management of the EU regulatory system

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Proposed changes to medical device legislation in Europe

Evolution of the Current EU Regulatory Regime

No central marketing authorization New regulation incorporates New Legislative Framework (economic operators) Effects of PIP scandal in terms of reinforced postmarket safety Support for innovation and competitiveness among SMEs Regulation as opposed to Directive
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Proposed changes to medical device legislation in Europe

Proposed Regulatory Framework

Covers medical devices and active implantables (separate legislation for IVDs) 194 pages Explanatory Memorandum Recitals (71) Chapters I-X (Articles), I-XVI (Annexes) Definitions (50)
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Proposed changes to medical device legislation in Europe

Scope
Medical Device coverage extended to aesthetic implantable/invasive products Shall not apply to Human tissues or cell manipulation Regulation-specific EMC or Machinery
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Proposed changes to medical device legislation in Europe

Definitions
Medical Device Accessory Label UDI Nanomaterial

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Proposed changes to medical device legislation in Europe

Definitions, contd.
Economic Operators (EO) Clinical Investigation Definitions Vigilance and Market Surveillance CTS prescribes technical specifications

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Proposed changes to medical device legislation in Europe

Transparency Traceability
Chapter II of new Regulation Emphasis on supply chain and device traceability Economic Operator responsibilities Requires Qualified Person (manufacturer and AR) Implant cards

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Proposed changes to medical device legislation in Europe

Manufacturers Responsibilities
Device must meet GSPR (Annex I): Art4(2) Technical documentation: Art8(2) Quality management system: Art8(5) PMSP and PMCF: Art8(6) Labeling Languages: Art8(7)

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Proposed changes to medical device legislation in Europe

Authorized Representation
Single Authorized Representative (AR): Art9(1) Effective at least for generic device group: Art9(2) AR terminates relationship if manufacturer acts contrary to Reg: Art9(3)(e)
AR informs Competent Authority and Notified Body Art9(5)

Changing AR: Art10

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Proposed changes to medical device legislation in Europe

Importer and Distributor Requirements

Importer name on device/packaging documentation accompanying device: Art11(3) Importer sample testing: Art11(6) Distributor that importer complied with Art11(3): Art12(2)(c)

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Proposed changes to medical device legislation in Europe

Qualified Person
Manufacturer and AR Expert knowledge field Qualifications Responsibilities Conformity Technical Documentation Vigilance
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Proposed changes to medical device legislation in Europe

Annex I: General Safety and Performance Requirements (GSPR)

Resembles the ER Chapter 1, Section 1: identical account the generally acknowledged state of the art Section 2: additional comments about risk ER #3-5 now consolidated into Section 3 ER #6a has been deleted

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Proposed changes to medical device legislation in Europe

Annex I, contd.
The following sections have been inserted: Devices incorporating medicinal product and devices composed of substances or combination of substances intended to be ingested, inhaled or administered rectally or vaginally Devices incorporating materials of biological origin Software in devices and standalone software Risks of medical devices for lay persons
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Proposed changes to medical device legislation in Europe

Annex I, contd.
Chapter 3 (Information supplied with the device) is extensive Section 19.1(b): information required on the label shall be provided on the device itself Not practical and appropriate exemption

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Proposed changes to medical device legislation in Europe

Transparency Traceability, contd.

Chapter III of new Regulation Establishes EU database for medical devices More extensive collection of information Unique Device Identifier (UDI) system Class III implantable devices require summary safety and clinical performance data

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Proposed changes to medical device legislation in Europe

Eudamed
Data entry Accessibility UDI Registration devices and EO Information certificates Clinical investigations Vigilance Market surveillance

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Proposed changes to medical device legislation in Europe

Oversight of Notified Bodies

Chapter IV of new Regulation Introduces significant new processes for Member States, national authorities and responsible NBs Authority peer reviewed second year Significant new processes for NBs

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Proposed changes to medical device legislation in Europe

Oversight of Notified Bodies, contd.

NB application MDCG and Joint Assessment Team (EU Commission) MS and COMM raise objections

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Proposed changes to medical device legislation in Europe

Monitoring Requirements NB
Every year: Authority Every third year: Joint Assessment Team Annex VI introduces minimum requirements for NBs

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Proposed changes to medical device legislation in Europe

Classification Conformity Assessments

Chapter V of new regulation Annex VII introduces new classification criteria (21 rules) New process for classification disputes Provisions for Notified Bodies Unannounced factory inspection system Sample checks (Physical, lab or other tests)

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Proposed changes to medical device legislation in Europe

Classification Conformity Assessments, contd.

Chapter V, continued
Notified Bodies required to inform European Commission and MDCG of Class III applications under review Annex II covers technical documentation requirements

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Proposed changes to medical device legislation in Europe

Classification Criteria
AIMD Class III, Rule 8 Active, controlled AIMD Class III Hip, knee, shoulder total/partial to Class III Tissue or cells of human/animal origin, non-viable: Class III, Rule 17 Nanomaterials: Class III, Rule 19

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Proposed changes to medical device legislation in Europe

Annex II: Technical Documentation

STED format Delineates elements of GHTF STED CER (Annex XIII) PMCF Plan (Annex XIII)

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Proposed changes to medical device legislation in Europe

Language and Labeling

Manufacturers responsibility: Art8(7)
Technical documentation: Annex II

Importer check: Art11(2)(e) Distributor check: Art12(2)(b) Member State end noncompliance: Art73(1)(e)

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Proposed changes to medical device legislation in Europe

Clinical Evaluation and Investigation

Chapter VI of new Regulation More explicit requirements (per Annex XIII and XIV) Database registration requirements Timeframes for Competent Authorities PMCF
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Proposed changes to medical device legislation in Europe

Vigilance and Market Surveillance

Chapter VII of new Regulation: Legislate MEDDEV 2.12/1, Rev. 7 More coordination required among Competent Authorities

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Proposed changes to medical device legislation in Europe

Vigilance and Market Surveillance, contd.

Competent Authority market surveillance obligations Procedures for compliant and non-compliant devices in terms of risks posed to public health and safety

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Proposed changes to medical device legislation in Europe

Incident and Serious Incident Definitions

Serious incidents are reportable 15 days after becoming aware of them Member States developing web system for reporting to healthcare professionals, users and patients

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Proposed changes to medical device legislation in Europe

Management of Regulatory System

Chapter VII of new Regulation Member State coordination with EU Commission MDCG Medical Device Coordination Group Notified Bodies, Class III issues, coordination of clinical data, vigilance, market surveillance and advice EU reference labs

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Proposed changes to medical device legislation in Europe

Conclusions
Weaknesses of existing Directives addressed Greater cooperation among Member States, Notified Bodies and Competent Authorities required Improvements to device traceability Greater control of Notified Bodies Three-year entry enforcement (from date of OJEU publication)

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Proposed changes to medical device legislation in Europe

Additional Resources
Current EU regulations for medical devices Pre-recorded webinar on CE Marking:
http://www.emergogroup.com/services/europe
Presented by:

http://www.emergogroup.com/resources/regulations-europe http://www2.emergogroup.com/videos-ce-marking-europe

Regulatory consulting services for Europe:

Evangeline Loh, PhD, RAC EMERGO GROUP | VP of Global Regulatory US office: +1.512.327.9997

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