Being prepared –the draft Medical Device Regulation in the EU · Content -Annex 3 –Unannounced...

Being prepared – the draft Medical Device Regulation in the EURegulation in the EU

Jan van LochemVice President Medical Devices, EMEABSI Group

Copyright © 2012 BSI. All rights reserved. 1

BSI Group

Herzliya, 22 April 2013

Lot’s of media attention in 2012 for medical devices

Breast implant 'butcher' at centre of PIP silicone scandal charged with 'unintentional harming'

Jean-Claude Mas, 72, taken into custody after raid on companion's villa and charged with 'unintentional harming'

Hip replacements: Questions and answersTens of thousands of patients who received hip replacements are at the centre of a major health alert over concerns they are poisoning their bodies, a Sunday Telegraph investigation has found..........

Copyright © 2012 BSI. All rights reserved. 222/04/2013

investigation has found..........

Chronological development (based on MDD)

Apr 2013Jun 1993 � Jun 1998 � Sep 2007 � Jun 2008 � Dec 2009 � Jun 2011 � Sep 2012 � Apr 2013

Years: 0 5 9 ¼ ¾ 1 ½ 1 ½ 1 ¼ ½

5 14 ¼ 15 16 ½ 18 19 ¼ 20

Jun ‘93: Council Directive 93/42/EEC on medical devices (MDD) publishedJun ‘98: MDD into forceSep ‘07: Revision MDD 2007/47/EC issuedJun ‘08: Commission starts RecastDec ’09: First draft of Code of Conduct Notified Bodies – NB5Jun ‘11: First version Code of Conduct Notified Bodies signed by 29 NB’sSep ‘12: Commission issues draft Medical Device RegulationApr ‘13: Parliament’s rapporteur ENVI committee issues draft amendment report


Where does that leave Industry, Notified Bodies, other stakeholders?

“I am not what happened to me,

I am what I choose to become.”

– Carl Gustav Jung


Players in law making

Council of Member States

EU Parliament

European Commission


Industry Member States Notified Bodies Patient groups Physician groups

MDR timelines

Most optimistic scenario

• July ’13 – Vote in ENVI Committee European Parliament

• Nov ’13 – Vote in European Parliament & Council of Ministers has final view

• Nov ’13 – Apr ‘14:Compromise between Parliament and Council, Commission works out final text• Nov ’13 – Apr ‘14:Compromise between Parliament and Council, Commission works out final text

• May ’14 - Elections European Parliament, old Parliament still approves MDR, comes into force

• Three year transition till May 2017, then in full force

Still far away?Realistic time line?


Things move fastAtmosphere has changed rapidly

3 Directives will become 2 regulations

Impact of becoming a regulation

• Direct entry into force

• No Transposition period • No Transposition period

• i.e. no transposition into national law

• There will be a 3 year transition period for MDD/AIMD

• There will be a 5 year transition period for IVD

• A regulation should result in more consistent application

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


applicable in a uniform manner and at the same time throughout the Union

Notified Bodies, Certificates and the Regulation

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

• AIMD, MDD and IVD EC Certificates issued before the regulation enters into force remain • AIMD, MDD and IVD EC Certificates issued before the regulation enters into force remain valid until expiration date

• AIMD, MDD and IVD EC Certificates issued after the regulation enters into force shall become void two years after the application of the regulation

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


Not all NB’s will be designated under the new MDR

77 Notified Bodies, 71 in EU

30 EU directives utilise Notified Bodies

MDD/

all 3, 13

• Machinery

• PPE

• RoHS

• WEEE

• REACH

• AIMD (active implants): 19 } 11

MDD only, 46MDD/

IVDD, 11

MDD/ AIMD, 7

13• REACH

• ………


• AIMD (active implants): 19 } 11

• MDD (medical devices): 77 } =>

• IVDD (in vitro diagnostics):24 }

http://ec.europa.eu/enterprise/newapproach/nando/

30

GermanyItalyUnited KingdomTurkeyCzech RepublicSlovakiaHungaryPolandAustria

Notified Body distribution

19%

AustriaNorwaySwedenDenmarkFinlandFranceGreeceIrelandLuxembourgNetherlands

9 %

8 %6 %6 %

5%

5%

3%3%

3%

8 %


NetherlandsPortugal Romania

• Top 7 in size:, FR, GE, IR, NL, UK cover >50% of products

• Old EU members: 45Notified bodies in 15 countries

• New EU members: 26 Notified Bodies in 7 countries, 5 have none

• MRA-countries: 6 Notified Bodies in 2 MRA members

…… Consider the Current Regulatory Landscape

• PIP fallout

• Commission Recommendation on Notified Body Audits

• Commission Implementing Regulation on Designation and Supervision of • Commission Implementing Regulation on Designation and Supervision of Notified Bodies

• Commission Recommendation on UDI

• Clinical data, Post Market Surveillance and Post Market Clinical Follow up

• Enforcement

• Central oversight

• Generalists to Specialists

• Cost of the Compliance Infrastructure


• Cost of the Compliance Infrastructure

Proposed Medical and In Vitro Diagnostic Device RegulationsCommission proposal

• Build on the strengths of existing directives …• Support innovation

• Rapid access to market

• Balance between pre- and post-market control • Balance between pre- and post-market control

• Cost-effective

• SMEs

• … but adapt and improve, especially in terms of • Health and safety

• Internal market

• Transparency

• Trust and confidence in the European regulatory system

• Health warning: clauses will appear, stay, change, disappear


• Health warning: clauses will appear, stay, change, disappear

Scope

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

• Scope Exclusions • 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)

ENVI Rapporteur


ENVI Rapporteur• Some cases of viable substances covered again

Standards and Common Technical Specifications

• Presumption of compliance using harmonized standards increased to include process and conformity assessment standards• QMS, risk management, clinical investigation, clinical evaluation and post –market clinical follow-up

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


Single Use Devices and Reprocessing

• Considered to be the manufacturer

• Reprocessing of single-use devices for critical use is prohibited (intended for surgically invasive procedures)

• EC has power to change definition of devices for critical use

• Removal of OEM’s name from label

• National provisions may be maintained or introduced

ENVI Rapporteur• Reusable unless ......; Approval process for class III; reprocessors can challenge ‘single use

status’; re-processors under the regulation


Parts and components

• New requirement for suppliers of parts or components.

• Responsibility to determine the part or component does not adversely affect the safety and performance of the device.• Substantiating evidence available to CA’s

• Part or component that significantly changes the performance or safety characteristics of a device shall be considered a device in its own right.


Electronic System of Registration of Devices and Economic Operators

• The EC will set up and manage an electronic system

• Manufacturers will submit information in electronic means

• Importers will submit information in electronic means• Importers will submit information in electronic means• All changes updated within one week

• Accuracy confirmed at least every 24 months

• Data shall be publically available

• Fees may be collected


Notified Bodies

• 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

ENVI Rapporteur• Notified Bodies not involved in class III devices and implants any more• Commission stronger role in surveillance of Notified Bodies


• Commission stronger role in surveillance of Notified Bodies

Likely Classification Changes to Class III

• AIMD and accessories

• Spinal disc replacement implants and implantable devices that contact the spinal column

• Devices incorporating nanomaterial

• Devices intended for aphaeresis

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

ENVI Rapporteur


ENVI Rapporteur• Devices intended to be ingested, inhaled, ....... remain at current classification level IIa

Conformity Assessment

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

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

ENVI Rapporteur• Centralized Pre Market Authorization for all class III devices and implants• Removal as much as possible competition between Notified Bodies

• Fees public and as equal as possible• Go to Notified Body in own Member State, otherwise justification


• Go to Notified Body in own Member State, otherwise justification

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 • 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


Recommendation on audits and assessments

• Version #18 or so

• Initiated by the Cabinet of John Dalli, now

EUROPEAN COMMISSION

• Initiated by the Cabinet of John Dalli, now continued by Cabinet of Tonio Borg

• Part of his ’Interim Measures’ on PIP case

• Legal form: Commission Recommendation

• Editorial comments from legal services being included at this stage

• Anticipated publication: May 2013

• Together with Decision on designation of NBs

Brussels, XXX

[…](2012) XXX draft

COMMISSION RECOMMENDATION

of XXX

on the audits and assessments performed by notified bodies in the field of medical

devices


(Text with EEA relevance)

Annex 3 – Unannounced inspections

1. Notified bodies should carry out unannounced audits at least once every third year. Notified bodies should increase the frequency of unannounced audits if the devices bear a high risk, if the devices of the

respective type are frequently non-compliant or if specific information provides reasons to suspect non-conformities of the devices or of their manufacturer. The timing of the unannounced audits should be unpredictable not take less than one day unpredictable. As a general principle an unannounced audit should not take less than one day and should be executed by at least two auditors.

2. Notified bodies may visit premises of critical subcontractors or crucial suppliers if this is likely to provide more pertinent information. In particular if main part of design development, manufacturing, testing or another crucial process is located there.

3. Notified bodies should check a recently produced adequate sample, preferably a device taken from the on-going manufacturing process, for its conformity with the technical documentation and with legal requirements. The check

should encompass a file review and a test. Notified bodies should, during/after unannounced audit, request all relevant technical documentation including previous test protocols and results. Test should be undertaken in accordance with testing procedure defined by manufacturer in technical documentation which has to be validated by the notified body. Test may also be performed by manufacturer under observation of the notified body ("witness testing"). The check of the


may also be performed by manufacturer under observation of the notified body ("witness testing"). The check of the

conformity of device should include verification of traceability of all critical components and materials.

Content - Annex 3 – Unannounced inspections

4. High risk devices: sample devices belonging to three different device type and every hundredthtype at the end of the production chain or in manufacturer's warehouse in a view of testing the conformity of the device types.

Devices which have or should have a different UDI number should be counted as different device types. [Variantscontaining a technical difference which might affect safety or performance of the device should be counted as a separate device type. Where variants are just dimensional size variants without introducing extra risks, they should be seen as one device type.] Samples tested by notified bodies or by qualified personnel under their observation in their own premises, in manufacturer's premises or in external laboratories. Sampling criteria and testing procedures should be defined in advance, manufacturer's premises or in external laboratories. Sampling criteria and testing procedures should be defined in advance, using a transparent mechanism of multi-stakeholder input. In particular if a sampling in the manufacturer's premises is not

possible, notified bodies should take samples from the market, with support by competent authorities, or should perform testing on a device installed at a customer location. Notified bodies should request from manufacturer all relevant technical documentation including final batch testing reports, previous test protocols and results.

5. QMS: manufacturing activity on-going at time of unannounced audit in line with manufacturer's documentation relevant for the manufacturing activity and that both are in conformity with legal requirements. Check in more

detail at least two critical processes such as design control, establishment of material specifications, purchasing and control of incoming material or components, assembling, software validation, sterilisation, batch-release, packaging, or

product quality control. Amongst the suitable critical processes, notified bodies should select one which has a high likelihood of non-conformity and one which is particularly safety relevant.


Content - contractual mess as excuse .. is a no-go.....

• Unannounced audits in premises of the manufacturer or of his critical subcontractors or crucial suppliers should be

foreseen in the contractual arrangements between the notified bodies and the manufacturers. If a visa is needed to inspect the manufacturer, the contractual arrangements should contain, as an annex, an

invitation to visit the manufacturer at any time and an invitation which leaves the date of signature and the invitation to visit the manufacturer at any time and an invitation which leaves the date of signature and the date of visit open (to be filled-in by the notified body). The contractual arrangements should also contain, as an annex,

similar invitations issued by the critical subcontractors or crucial suppliers.

• Contractual arrangements should foresee that the manufacturers continuously inform the notified bodies on dates when devices falling under notified bodies' certificates will be manufactured.

• Contractual arrangements should authorise the notified bodies to end the contract as soon as his permanent unannounced access to the premises of the manufacturer or his critical subcontractors or crucial suppliers is no longer assured.

• Contractual arrangements should furthermore cover the measures to be taken by notified bodies to ensure the

security of their auditors. It should provide for a financial compensation for the unannounced audits including, when applicable, device acquisition and security arrangements.


NEW: Unannounced visits - NB MED interim input to Commission

• Knocking unannounced on door, not short notice, is that feasible ??

• Common guidance is needed !!• Impractical for all audits to be unannounced

• When should NB do unannounced visits, high risk, triggers from market, whistle blowers etc.

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NB-MED

• When should NB do unannounced visits, high risk, triggers from market, whistle blowers etc.

• What is focus of the audit?• Relate to product, reconciliation of materials, criminal activities, PMS, witness testing, but not QMS focussed. Specialist would have dedicated competence

• Difficulty in delivery:• Visa, legal manufacturers � critical subcontractors

• In association with CA (on their request, joint audits)

• OBL manufacturers


• OBL manufacturers

• NB T&C redefined where needed to include right of access and actually do them on more frequent basis

• Change of relationship with existing manufacturers (policing)

• What happens with violations of criminal nature identified

• Time needed for the audit?

• Need to be covered by CA oversight to have consistent implementation

Clinical Evaluation & Clinical Investigation

• Detailed review in presentation Dr. Gert Bos

Key ‘take home’ messages:Key ‘take home’ messages:

• Stringent application of MEDDEV 2.7.1 on clinical evaluation

• Evaluation without own study: equivalence must be very strong

• Notified Bodies forced to involve more clinical experts in review

• PMS and PMCFP are key integral elements


“Please ... Stop. That’s enough surely?”


Budgetary Implications: Costs

• Development of the Eudamed database (one-off costs and maintenance)

• Commission staff organising and participating in 'joint assessments' of notified bodies

• National assessors participating in 'joint assessments' of notified bodies• National assessors participating in 'joint assessments' of notified bodies

• Commission staff supporting the MDEG and its sub-groups

• Commission staff managing the Regulation and developing the delegated / implementing acts

• Organisation of meetings of the MDEG and its sub-groups, of the advisory committee on borderline issues, and of the Committee under Regulation 182/2011 , including reimbursement of the members appointed by the Member States

• Reporting members of the MDEG preparing opinions on notified bodies'


• Reporting members of the MDEG preparing opinions on notified bodies' preliminary conformity assessments of high risk devices

• Organisation of meetings of the Scientific Advisory Committee, including reimbursement of its members

• The functioning of the EU reference laboratories

• Participating in international regulatory cooperation

Budgetary Implications: Finding the Money

• 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 feesfees

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

• 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 LaboratoriesFees for scientific opinions provided to notified bodies and manufacturers


• Fees for scientific opinions provided to notified bodies and manufacturers

22/04/2013

How much time left ........?

• Atmosphere has changed in public debate in Europe

• Authorities want to show they can be tough now to Notified Bodies

• Will influence behaviour of Notified Bodies• Will influence behaviour of Notified Bodies

• 3 Notified Bodies already stopped in the last 3 months

• Joint audits of Designating Authority with 2 other Member States plus Commission inspectors – 20 scheduled for 2013

• Increasing number of COEN requests, challenging NB decision on clinical evaluation

• Outcome could be quick adoption of key improvements where there is agreement, fundamental changes may take longer


fundamental changes may take longer

22/04/2013

Conclusions: Influence or React? Commit or Commentate?

• Strategic Decisions: What is best for your business?• Influence to best defend your business

• React to make sure your systems meet the needs of new regulations

• Commit to best prepare your business• Commit to best prepare your business

• Commentate to respond to regulations and play catch up

• Must haves• Specialist regulatory and quality system professionals

• Bigger regulatory and compliance budgets

• In: Commitment to Compliance

• Out: Just get me a certificate


Conclusion: Get involved

• Read the Draft Regulation

• Participate in Commenting on the Draft


• Participate in Commenting on the Draft

• Begin discussions and planning within your own organizations

Being prepared –the draft Medical Device Regulation in the EU · Content -Annex 3 –Unannounced...

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