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Proposed Regulations – NB view. Gert Bos Head of Regulatory and Clinical Affairs – BSI President – TEAM-NB IMDA Quality & Regulatory Forum, 25-10-2012. Guide to the Presentation. BSI – slides: TEAM-NB slides:. Legal form.

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Proposed regulations nb view

Proposed Regulations – NB view

Gert Bos

Head of Regulatory and Clinical Affairs – BSI

President – TEAM-NB

IMDA Quality & Regulatory Forum, 25-10-2012

Guide to the presentation
Guide to the Presentation

  • BSI – slides:

  • TEAM-NB slides:

Legal form
Legal form

  • More details captured in Regulation than Directives

    • combining MDD and AIMDD makes sense

    • IVDD is not too different…………

  • Appropriate legal instrument that imposes clear and detailed rules which become applicable in a uniform manner and at the same time throughout the Union

    • divergent transposition of directives by MS has led to different levels of health and safety protection and created obstacles to the internal market which can only be avoided by a Regulation

    • important simplification effect allowing economic operators to conduct their business based on one regulatory framework, rather than a 'patchwork' of 27+ national laws

    • more harmonized implementation on designation, ERs

    • BUT…. what about approval of clinical trials, market surveillance & enforcement, vigilance actions, detailed instructions to and oversight on NBs……..

    • detailed implementing legislation – need for transparent stakeholder involvement

Notified bodies certificates and the regulation
Notified Bodies, Certificates and the Regulation

  • Well described transitioning:

    • Designations under AIMD, MDD, IVD become void at the date of application of the regulation

    • EC Certificates issued before the regulation enters into force remain valid until expiration date

    • EC Certificates issued after the regulation enters into force shall become void two years after the application of the regulation

    • Certificates against the new regulations can be issued by notified bodies designated under the new regulations before the date of application of the regulation


  • Ready to assess scope additions – waiting for NBOG codes

    • Products utilizing non-viable human tissues or cells unless they are covered by the Advanced Therapy Medicinal Products (ATMP) – e.g. syringes prefilled with human collagen

    • Certain products with no medical purpose, but, similar devices in characteristics and profiles – e.g. non-corrective contact lenses, implants aesthetic purposes

    • High-risk devices manufactured and used within a single health institution

      • Must meet the majority of the proposal’s requirements

    • Genetic tests providing information about the predisposition to a medical condition or a disease and tests providing information to predict treatment response or reactions

      • Considered as in vitro diagnostic medical devices (e.g. companion diagnostics)

  • cope Exclusions - no major impact ?

    • Products containing viable biological substances

    • Food covered by other EU regulations (slimming products) – devices now excluded from food regulations

  • EC empowered to confirm regulatory status of product(s) – improvement

Reclassifications no surprises
Reclassifications – no surprises

  • Provides mechanism to change classification – anticipate future up classification based on ‘media-level’

    • Brings AIMD and accessories are class III

    • Identifies spinal disk replacement implants and implantable devices that contact the spinal column are class III

    • Devices incorporating nanomaterial are class III

    • Devices intended for aphaeresis are class III

    • Devices intended to be ingested, inhaled or administered rectally or vaginally and are wholly or partially absorbed by or dispersed in the human body are class III

  • New risk-rule based classification system for IVD

    • GHTF principles; replaces the current Annex II listing of IVD Directive 98/79/EC

  • Four classes of risk: A (lowest risk), B, C and D (highest risk)

  • Concept of batch testing clarified

Standards and common technical specifications
Standards and Common Technical Specifications

  • Presumption of conformity using harmonized standards increased to clearly include process / conformity assessment standards

    • QMS, risk management, clinical investigation, clinical evaluation and post –market clinical follow-up

    • Unclear future of harmonization

    • ………..

  • Allows the possibility for the EC to mandate common technical specifications (CTS)

    • Not too happy with COEN balloon on comparative analysis

    • Will need coordinated action in transparent way

Qualified person and authorised rep realistic requirements
Qualified Person and Authorised Rep – realistic requirements

  • Manufacturers will be required to have a qualified person available within their organization, who has medical device expertise

    • Either education requirements plus two years medical device RA / QA experience or five years medical device RA / QA experience

  • Protected when properly fulfilling responsibilities

  • Responsibilities include

    • Statements re clinical investigation devices ER compliance and protection of subjects

    • Conformity of devices confirmed before batch release

    • Technical documentation and declarations of conformity are current and maintained

    • Reporting obligations are met

  • EU Representatives shall also have qualified person

    • Expert knowledge of EU medical device regulations

    • Similar to manufacturer QP qualifications

Electronic system on registration of devices and economic operators
Electronic System on Registration of Devices and Economic Operators

  • The EC will set up and manage an electronic system

  • Manufacturers will submit information for the database

  • Importers will submit information

    • All changes updated within one week

  • Accuracy confirmed at least every 24 months (??)

  • Data shall be publically available

  • Fees may be collected

  • Reliability, transparency, IT security, privacy protection, ….


  • Summary of Safety and Clinical Performance

    • For all class III and implantable devices

    • Submitted to Notified Body for review

    • Notified Body will validate

    • Must be understandable by users

  • More detail vigilance reports centrally available?

Notified bodies
Notified Bodies

  • National authorities responsible for notified bodies

    • Separate from notified bodies

    • Sufficient resources

    • Consult with competent authority for medical devices as appropriate

    • Peer review every two years, Commission invited to participate

  • Significant new requirements regarding the designation, competence, scope, monitoring and maintenance of notified bodies

  • Requirement to issue certificates and status in database

  • Procedure for changing notified bodies

  • Current notified bodies will need to apply for and achieve designation under the new regulation

    • National Authority shall notify to the EC, MS and MDCG

    • Scopes of NB’s will be competence specific

Conformity assessment
Conformity Assessment

  • Annex VIII Full Quality Assurance

  • Introduction of a minimum frequency for unannounced visits (taking account of device risks / types) – prevention of hostile environment

  • Tests to be carried out by notified bodies – sample checks – big debates

  • Notified body shall rotate the members of the audit team (no more than three years per lead auditor)

Scrutiny of certain conformity assessments to pma or not
Scrutiny of Certain Conformity Assessments – ….. to PMA or NOT

  • Notified bodies shall notify the Commission and MDCG of new applications for class III devices and estimate for certification date

    • Within 28 days the MDCG may request submission of a preliminary summary

      • NB 5 days to inform manufacturer

    • Up to 60 days after receiving the summary to request further information

      • Within 30 days request further information (stop the clock on 60 days)

      • Further requests possible

    • NB shall address concerns received back from the MSCG and justify any CE decisions

    • Summary and outcome made public

  • Do authorities have resources? Will they outsource? Quality of review?

Unannounced visits
Unannounced Visits

  • Notified body shall randomly perform unannounced factory inspections and if appropriate suppliers / subcontractors

    • Could replace a periodic surveillance assessment ?

  • Notified body shall establish a plan for unannounced factory inspections which shall not be disclosed to the manufacturer

  • Within the context of unannounced factory inspections the notified body shall check an adequate sample of devices from production to verify compliance with technical file

    • Notified body could take samples from the market and verify compliance with technical file

Budgetary implications finding the money biggest change of all
Budgetary Implications: Finding the Money – biggest change of all??

  • The Commission, the Member States or and the designated EU reference laboratories will charge fees for various activities

  • The Commission will use implementing acts to set the level and structure of fees

  • The Commission

    • Fees for the registration of medical devices in the central database

    • Fees for the issue of scientific advice provided at the request of a manufacturer or notified body

  • The Member States

    • Fees for the designation and monitoring of notified bodies

    • Transfer a portion to the Commission to finance the 'joint assessments' and the scrutiny mechanism for high risk devices

  • EU Reference Laboratories

    • Fees for scientific opinions provided to notified bodies and manufacturers

Clinical evaluation clinical investigation
Clinical Evaluation & Clinical Investigation

  • Regulation combines and incorporates current guidance's on clinical evaluation and clinical investigation

  • Significant requirements on clinical

    • General requirements – sponsor responsibilities

    • Application

    • Registration

    • Electronic system

    • Post market clinical investigation requirements

    • Substantial modification

    • Sponsor information obligations regarding suspension / termination

    • Event reporting

Team nb

  • To improve communications with

    • the EC Commission,

    • Industry,

    • Competent Authorities and

    • User Groups

  • To promote high technical and ethical standards

  • Members are Notified Bodies under any or all of the 3 medical devices directives:

    • 90/385/EEC - AIMD

    • 93/42/EEC - MDD

    • 98/79/EC - IVD

Code of conduct
Code of Conduct

  • Mandatory to sign for TEAM-NB members

  • Available on website

  • Changes and additions:

    • Extension to IVD

    • Unannounced visits

    • Product Verification

    • Supervisory Structure

    • Peer assessment

Detailed content coc v3
Detailed content CoC V3

  • Implementation, enforcement and monitoring of the Code of Conduct

  • Qualification and Assignment of Notified Body Assessment Personnel

  • Minimum time for Notified Body assessments

  • Unannounced visits

  • Sampling of class IIa and IIb technical files

  • Design Dossier Reviews

  • Rules for subcontracting

  • Rules for Certification Decisions

Quality of notified body work
Quality of Notified Body work

  • Code of Conduct addresses where NBs diverge

  • Detailed requirements with less room to interpret

  • Result must be more consistent

  • Requires consistency in oversight => cross-inspections




Time spent



Statement towards daily telegraph
Statement towards ‘Daily Telegraph’

  • TEAM-NB members are committed to ensure the safety of Medical Devices on the EU market

  • TEAM-NB members abide by regulatory and ethical aspects by law as well as on voluntary basis

  • TEAM-NB members agree to be submitted to a strong and harmonized assessment and surveillance system by member states and commission

  • TEAM-NB members are fully aware of their responsibility to ensure certification of medical devices complies with the Directives