Speaker Presentation

Getting Started with CE Marking: Your Passport to Europe

Suzanne Halliday BSI Healthcare 15.June.2011

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Course Description: •

This session will help you gain a basic understanding of the CE marking regulatory process and the Medical Device Directive (MDD) regulations that govern placing products into the EU. Learn the thinking behind the different device risk classifications and when you need a Notified Body. Plus the importance of technical documentation, vigilance and the role of harmonized standards.

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Learning Objectives: • Overview of the European Union Marketplace. • Understand the purpose and basic requirements for CE Marking. • Fundamentals of Risk Classification and Routes to Conformity. • Learn the relationship of Quality and Risk Management with the MDD. • Understand the role of a Notified Body. • Identify the steps required to place a device on the market in the EU market.

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European Union Directives & Regulations

Notified Bodies & European Medicines Agency

De-harmonisation of Standards

Recast

93/42/EEC – in One Slide

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Medical Device

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93/42/EEC 1.

Check Scope of Medical Device Directive

2. Determine “Device Class”

(Article 1) (Article 9, Annex IX)

3. Select “Conformity Assessment Procedure” (Article 11) 4. Identify Applicable “Essential Requirements” (Article 3, Annex I) 5. Assemble “Technical Documentation” 6.

Apply Conformity Assessment Procedure

7. Complete “Declaration of Conformity” 8.

Affix “CE Mark”

(Annex II, III, VII) (Annexes II-VII) (Annexes II-VII) (Annex XII)

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Active Implantable

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In Vitro Diagnostic

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90/385/EEC & 98/79/EEC •

90/385/EEC only has “Active Implantable Medical Device” classification of devices.

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98/79/EEC classifies devices based on lists and not rules.

Medical Device

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93/42/EEC ‘Medical device’ means any instrument, apparatus, appliance, software, material or other article … intended by the manufacturer to be used for human beings for the purpose of: • • • •

diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for injury or handicap, investigation, replacement or modification of anatomy or physiological process, control of conception,

and which does not achieve its principal intended action … by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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90/385/EEC ‘Active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity; ‘Active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

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98/79/EEC ‘In vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: • concerning a physiological or pathological state, or • concerning a congenital abnormality, or • to determine the safety and compatibility with potential recipients, or • to monitor therapeutic measures.

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2001/83/EC & 2004/27/EC ‘Medicinal product’ means •

any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

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any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

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Devices assisted by Medicines

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76/768/EEC ‘Cosmetic product’ means any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.

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89/686/EEC Personal Protective Equipment (PPE) shall mean any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards. • • • • • • • • • • •

mechanical action (gardening gloves), cleaning materials (gloves affording protection against detergents), heat (insulated aprons), atmospheric agents (headgear & seasonal clothing) minor impacts and vibrations (helmets), sunlight (sunglasses), dangerous or toxic gases (respiratory equipment), atmosphere (diving equipment), ionizing radiation (lead aprons) falls from a height (harness), electrical risks (insulated shoes).

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Cosmetics

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Personal Protective Equipment

Classification

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Classification divides Products into Risk Categories:

• Class III - highest risk • Class IIb - medium to high risk • Class IIa - medium risk • Class I - lowest risk (*measuring & sterile)

Risk classification is based on the manufacturer’s intended purpose.

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Notified Body Involvement Depends on Risk:

Device Classification: Manufacturing and Design Control Manufacturing Control Self-Certification

Risk

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Article 1 & Annex IX Important Definitions: Article 1: Medical Device, Accessory, Custom Made, Intended for Clinical Investigation, Intended Purpose, Single Use. Annex IX: Duration of Contact, Degree of Invasiveness, Reusable Surgical Instrument, Active, Central Circulatory System, Central Nervous System.

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Duration of Contact:

• Transient: 30 days

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Degree of Invasiveness: • Invasive ƒ

Penetrates inside the body via an orifice or through the surface.

• Body orifice ƒ

Natural opening or permanent artificial opening (stoma).

• Surgical ƒ

Penetrating through the surface with the aid of a surgical operation.

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18 Classification Rules:

1-4

Non invasive devices

5-8

Invasive devices

9 - 12

Active devices

13 - 18 Special rules

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Special Rules: Rule 13 - medicines & human blood derivatives

Rule 13

Rule 14 - contraception Rule 15 - disinfecting Rule 16 - recording x-ray Rule 17 - ‘utilising animal tissue’

Rule 14 Rule 15

Rule 18 - blood bags

Rule 17

Rule 16

Rule 18

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Classification Amendments: • 2003/12/EC ƒ

Breast implants raised to class III.

• 2005/50/EC ƒ

Hip, knee and shoulder joint replacements raised to class III.

Syringes

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No numbers Class IIa Rule 6

Pre-filled with medicine Not a device

No needle Class I Rule 2

Empty Class IIa Rule 6

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Gloves Examination Gloves Transient Invasive into Body Orifice

Surgical Gloves Transient Surgically Invasive

Class I Rule 5

Class 2a Rule 6

Conformity Assessment

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Notified Body Involvement: Classification

Design

Production

Class I Class IIa Class IIb Class III

Self-Declaration Notified Body* Notified Body # Notified Body —

Self-Declaration Notified Body Notified Body Notified Body

* Sampling of subcategories. # Sampling of generic device groups. — Review of Design Dossier.

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Custom Made Devices

Annex VIII Technical Doc. Vigilance System

Name of Medical Practitioner & Patient + Meets Requirements of Annex I

Article 4

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Class I Device (non-sterile / no measuring function)

Annex VII Technical Doc. Vigilance System

Declaration of Conformity & CE Marking

Article 11 Point 5

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Class I Device (sterile / measuring function)

Annex VII Technical Doc.

* Only aspects related sterility / measuring function

Vigilance System

Annex II*

Annex IV*

Annex V*

Annex VI*

Technical Doc. Vigilance System Full Quality Assurance

Batch Verification

Production Quality Assurance

Final Inspection and Testing

Declaration of Conformity & CE Marking

Article 11 Point 5

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Class II a Device

Annex II

Annex VII

Technical Doc. Vigilance System Full Quality Assurance

Technical Doc. Vigilance System

Annex IV

Annex V

Annex VI

Batch Verification

Production Quality Assurance

Final Inspection and Testing

Declaration of Conformity & CE Marking

Article 11 Point 2

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Class II b Device

Annex II

Annex III

Technical Doc. Vigilance System Full Quality Assurance

Type Examination

Annex IV

Annex V

Annex VI

Batch Verification

Production Quality Assurance

Final Inspection and Testing

Declaration of Conformity & CE Marking

Article 11 Point 3

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Class III Device

Annex II.4

Annex III

Design Dossier Review

Type Examination

Annex II

Annex IV

Annex V

Full Quality Assurance

Batch Verification

Production Quality Assurance

Declaration of Conformity & CE Marking

Article 11 Point 1

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AIMD Device

Annex III Type Examination

Annex II Full Quality Assurance

Annex IV

Annex V

Batch Verification

Production Quality Assurance

Declaration of Conformity & CE Marking

Article 11 Point 1

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IVD Device

Essential Requirements

Safe

Безопасно – Russian

Essential Requirement #1 Невредим – Bulgarian

Veilig – Dutch

Varen – Slovenian

Bezpieczny – Polish

Ασφαλής – Greek

Ddihangol – Welsh

Sûr – French

Seguro – Portuguese

Turvallinen – Finnish Sikker – Danish

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Sicuro – Italian Sicher – German

Öruggur - Icelandic Säker – Swedish Neporušený – Slovak Seguro – Spanish Biztonságos – Hungarian Pengeskap – Norwegian Siguran – Croatian Neskarts – Latvian Sağlam - Turkish Bezpečný – Czech Ohutu – Estonian Sejf – Maltese Siguran – Serbian Ferit – Romanian Slán – Irish Saugus – Lithuanian

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Essential Requirement #2

“State of the Art”

Perform

Выполните – Russian Îndeplini – Romanian

Essential Requirement #3 Presteer – Dutch Извършвам – Bulgarian

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Izvršiti nalogo – Slovenian Εκτελέστε – Greek

Exécutez – French

Execute – Portuguese Effettui – Italian Esiintyä – Finnish Führen Sie durch – German Utföra – Swedish Realícese – Spanish Præstere – Danish Predvádzať – Slovak Chyflawna – Welsh

Izpildīt – Latvian

Utføre - Norwegian

Framkvæma – Icelandic Végrehajt – Hungarian

Obaviti – Croatian Běžet - Czech Izvoditi – Serbian Teostama – Estonian Daryti – Lithuanian

Comhlíon – Irish

Dokonywac – Polish Oynamak – Turkish Ħadem – Maltese

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Essential Requirement #4 “Lifetime” -

Product shelf life

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Product life in vivo

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“Life Cycle” in EN ISO 14971:2009 – “all phases in the life of a medical device, from the initial conception to final decommissioning and disposal”

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EXAMPLES transportation, storage, installation, product use, maintenance, repair, product changes, decommissioning and disposal

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Essential Requirement #5 -

Packaging seal strength Packaging dye penetration Packaging maintenance of sterile barrier Packaging transit testing

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Product transit testing Product shelf life

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Essential Requirement #6

“Benefits > Risks”

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Essential Requirement #6a Systematic Review

1. Objectives  • Safety • Performance • Substantiated Claims 2. Identify 3. Select – Similar or Equivalent 4. Appraise / Review / Analyse / Weight 5. Critically Evaluate 6. Clinical Evaluation / Risk Management  Relationship 7. Inclusion of PMS Information 8. Conclusions 9. References 10. Qualifications

GHTF  N2R8 (2007)

MedDev   2.7.1 (2009)

3 3 3 3 3 3 3 3

3 3 3 3 3 3 3 3

3 3 3 3

3 3 3 3

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QMS

PMS NBMed 2.12 Vigilance MedDev 2.12-1 Reactive PMS

Proactive PMS

Post Market Clinical Follow-up MedDev 2.12-2

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Essential Requirements #7-13

7. Chemical, Physical & Biological Properties 8. Infection & Microbial Contamination 9. Construction & Environmental Properties 10. Devices with a Measuring Function 11. Protection against Radiation 12. Connected to or Equipped with an Energy Source 13. Information Supplied by the Manufacturer

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Essential Requirements Check List Essential Essential Requirement Requirement 11 The The device device must must be be designed designed and and manufactured manufactured in in such such aa way way that, that, when when used used under under the the conditions conditions and and for for the the purposes purposes intended, intended, they they will will not not compromise the clinical condition compromise the clinical condition or or the the safety of patients, or the safety and safety of patients, or the safety and health health of of users users or, or, where where applicable, applicable, other other persons, persons, provided provided that that any any risks risks which which may may be be associated associated with with their their use use constitute constitute acceptable acceptable risks risks when when weighed against the benefits weighed against the benefits to to the the patient patient and and are are compatible compatible with with aa high high level level of of protection protection of of health health and and safety. safety.

Applicable

Demonstration of Compliance

Location of Evidence

A/NA

Horizontal Standards

Vertical Standards

Test Reports

Location

A/NA

Applicable Harmonised Standards & Specifications

Technical File Record

Location

Fulfilled

Relevant Standards Considered

Reports/ Justification

Technical Documentation

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93/42/EEC – Annex VII The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular: • general description of the product and intended use(s), • design drawings, methods of manufacture, diagrams of components, • explanations necessary to understand the operations of the product, • results of the risk analysis, • list of harmonised standards, applied in full or in part, • descriptions of the solutions adopted to meet the ERs, • in the case sterile products validation report,

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93/42/EEC – Annex VII and … : • results of the design calculations and inspections carried out, • if the device is to be connected to other device(s), proof must be provided that it conforms to the ERs, • solutions adopted as referred to in Annex I, • pre-clinical evaluation, • clinical evaluation in accordance with Annex X, • label and instructions for use.

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93/42/EEC – Annex II The Quality System … shall include documentation, data and records arising from the procedures for monitoring and verifying the design of the products including: Additional: • statement indicating whether or not the device incorporates a medicinal substance or a human blood derivative, • statement indicating whether or not the device is manufactured utilising tissues of animal origin.

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Updating the Information: Updated Legislation

Updated MEDDEV Documents

New Harmonised Standards

State of the Art Device Placed on Market

Future Audits

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Custom, Class I, Class I sterile & Class I measuring:

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Notified Body Involvement: Classification

Design

Production

Class I Class IIa Class IIb Class III

Self-Declaration Notified Body* Notified Body # Notified Body —

Self-Declaration Notified Body Notified Body Notified Body

* Sampling of subcategories. # Sampling of generic device groups. — Review of Design Dossier.

Declaration of Conformity

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DOC NB-Med Consensus Statement: Title of the document

Declaration of Conformity

Identification of the legal entity

Name and address of the manufacturer (and authorised representative)

Identification of the device(s)

Name, type or model

Identification of products where The DoC may cover particular lots, batches, required for the selected conformity serial numbers, particular products types assessment procedure. and/or particular periods of manufacture. A statement that the identified devices meet the applicable provisions of the Directive.

'We hereby declare that the above mentioned devices comply with the legislation of the UK transposing European Medical Devices Directive 93/42/EEC'

Date of validity

Date from which the DoC is valid

Identification of the person authorised to sign.

Name, position and signature of the person, who is approving the DoC

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Denmark

Austria Czech Republic Bulgaria

Greece

France

Finland Estonia

Hungary Ireland

Belgium

Germany Italy

United Kingdom Lithuania

Sweden

Luxembourg Malta

Switzerland Slovakia

Slovenia Spain

Latvia

Poland

Portugal

Romania

Cyprus

The Netherlands Norway

Liechtenstein