getting ce marking for medical devices in europe

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The CE Marking Process for Medical Devices

CE Marking: The Medical Device Approval Process in Europe

Steps to obtain certification necessary to market your device in the European Union



Key Topics We Will Cover:

• Overview of the EU market

• Overview of the Medical Device Directives

• Medical Device Classification

• ISO 13485 Quality Systems

• Technical File Compilation

• Authorized Representation Requirements

• Risk Assessments

• Labeling Requirements

• Language Translation Challenges

• Post-market Surveillance



Overview of the European Union

• 27 member states plus European Free Trade Association members (Norway, Switzerland, Iceland and Liechtenstein)

• Population of more than 500 million people

• 23 languages



EU Directives Impacting Medical Devices

Medical Devices (MDD) 93/42/EEC

Covers the bulk of medical devices marketed in the EU

Examples: orthopedic implants, heart valves, medical software




Active Implantable Medical Devices (AIMDD) 90/385/EEC

Covers devices that require external power sources in order to function properly

Examples: pacemakers, implantable defibrillators




In Vitro Diagnostics (IVDD) 98/79/EC

Covers devices used for the examination of specimens taken from the human body

Examples: pregnancy self-testing strips,

blood glucose self-testing strips



Other EU Medical Directives/Regulations These EU directives and regulations may also apply to medical devices:

•Personal Protective Equipment 89/686/EEC

•Low Voltage 2006/95/EC

•Electromagnetic Compatibility 2004/108/EC

•Blood Product Directive 2002/98/EC

•Animal Tissue Use in Medical Devices 2003/32/EC

•Human Tissue Products Directives 2004 & 2005

•Breast Implants Reclassification Directive 2003/12/EC

•Hip, Knee, Shoulder Joint Replacement Reclassification Directive 2005/50/EC



Key Players in the CE Marking Process

•Manufacturers and Subcontractors

•Competent Authorities

•Notified Bodies

•Authorized Representatives

•Distributors



Competent Authorities

Competent Authorities are entities enforcing Medical Device Directives at the national level in each EU member state.

Important: member states and their Competent Authorities each have their own interpretations of how Directives should

be carried out. Manufacturers seeking to sell in more than one EU member state should take this into account.



Notified Bodies Notified Bodies are authorized to audit manufacturers’ quality systems and test

/review devices for compliance with applicable EU Directives and standards.

Notified Body responsibilities include:

•Advising on device classification and Conformity Assessment routes

•Pre-assessment of devices

•Product and quality system evaluation

•Concluding and evaluating manufacturers’ Corrective Actions

•Issuance of certifications

•Maintaining programmed surveillance of devices in the EU



Authorized Representative Required for any firm without a location in the EU.

Authorized Representatives’ responsibilities may include:

•Liaising between manufacturers and Competent Authorities

•Listing their names on clients’ device labels and packaging

•Notifying Competent Authorities of manufacturers’ and devices’ names

•Keeping Technical Files/Design Dossiers available for review by Competent Authorities

•Participating in vigilance/post-market surveillance procedures



Basic Steps to Compliance in the EU

1. Identify Directives and Regulations appropriate for your device.

3. Implement Quality System in compliance with ISO 13485.

4. Prepare Technical File or Design Dossier demonstrating compliance with MDD 93/42/EEC.

2. Classify your device according to MDD Annex IX



Steps to Compliance in the EU, cont.

5. Appoint your Authorized Representative.

6. Have Notified Body audit your Quality System and Technical File or Design Dossier

7. Register your device with Competent Authorities if necessary.

8. Prepare Declaration of Conformity and affix CE Marking to your device.



Step One: Classification/MDD Determination

First, determine which Medical Device Directive (MDD, AIMDD or IVDD) applies to your device. Then determine device

classification using Annex IX of MDD 93/42/EEC.

Class I Non-Sterile Class I Non-Measuring

Low-risk, non-invasive devices such as non-sterile wound dressings and stethoscopes

Class I Sterile Class I Measuring



Classification, cont’d.

Class IIa

Medium-risk, short-term invasive devices such as tracheal tubes and lancets



Classification, cont’d.

Class IIb

Higher-risk, often longer-term surgically invasive, sometimes implantable devices including intra-ocular

lenses and surgical lasers



Classification, cont’d

Class III

Highest-risk devices, including all active implantable devices such as replacement heart

valves and vascular stents



Classification Considerations MDD 93/42/EEC Annex IX contains 18 rules for medical device

classification based on factors including the following:

•Device’s intended use

•Active versus non-active functionality

•Device’s duration of contact with patient

•Degree of invasiveness

•Part of body contacted by device

•Special situations



How Classification is Determined

Duration of Contact Criteria Degree of Invasiveness Criteria

Less than 60 minutes = Transient

Less than 30 days = Short-term

More than 30 days = Long-term

Application to body surface versus an orifice

Surgically invasive or non-invasive

Implantable

Determining your device’s duration of contact and degree of invasiveness will help determine how to classify the device.



How Classification is Determined, cont’d.

Transient Transient

Short Term Long Term Long Term

Class I Sterile/Measuring Class I Non-sterile/Non-measuring

Class IIa Class IIb Class III

Low-risk Low-risk

Medium-risk Medium-risk

High-risk



Step Two: Quality System

Manufacturers of Class I sterile/measuring, IIa, IIb and III devices must implement quality management systems (QMS) (in

compliance with Annex II or V of the MDD).

Most manufacturers meet this requirement using ISO 13485.



Quality System Requirements: ISO 13485

Phase I: Quality system preparation and development

•Management buy-in •Assign resources and staff •Conduct gap analysis •Develop quality manual and documentation controls



Quality System Requirements, cont’d.

Phase II: Implementation

• Employee training

• Internal auditing

• Corrective and preventative actions



Quality System Requirements, cont’d.

Phase III: Registration

• Registration audit performed by Notified Body

• Final ISO 13485 certification



Step Three: Technical File/Design Dossier Preparation

• All Class I, IIa and IIb device manufacturers must prepare Technical Files containing data to demonstrate MDD 93/42/EEC compliance.

• Class III device manufacturers must prepare Design Dossiers to demonstrate compliance to MDD.

• All manufacturers must have clinical data to demonstrate compliance to MDD.



Technical File Components A CE Mark Technical File should include the following sections:

1. Description of product family and justification for why your device falls into that family

2. Device intended use

3. Description of device components, specifications, packaging and literature

4. Device manufacturing Process

5. List of accessories to your device

6. Location of design responsibility and manufacturing facilities

7. Classification along with rationale for classification



Technical File Components, cont’d.

8. Chosen compliance route according to applicable Directive(s)

9. Declaration of Conformity stating manufacturer’s compliance with applicable Directive(s)

10. Shelf life and environmental limitations of device

11. Retention of quality assurance, Competent Authority and Notified Body records

12. Vigilance reporting and Medical Device Reporting procedures

13. How and when to contact Competent Authorities

14. Name of and contract with your Authorized Representative



Technical File Components, cont’d.

15. Subcontractor names and addresses if applicable

16. Essential Requirements

17. Design input specifications

18. Application and references to Standards and Guidelines

19. Testing results and clinical evaluations

20. Risk analysis

21. Instructions for Use and Labeling



Technical File Components: Clinical Data Requirements

• EU regulators have increased their requirements for clinical data even for Class I medical devices in recent years.

• In many cases, manufacturers must submit Clinical Evaluation Summary Reports that verify the safety and performance of their products along with Technical Files or Design Dossiers.



Step Four: Authorized Representation

Manufacturers with no offices in the EU must appoint

Authorized Representatives (EC REPs) to interact with regulators on their behalf.



EC REP Responsibilities May provide several vital services for foreign manufacturers:

•Registering your device with Competent Authorities before commercialization

•Serving as primary point of contact with all EU Competent Authorities

•Keeping a current copy of your Technical File/Design Dossier available for inspections by Competent Authorities

•Authorizing you to place EC REP name and address on your device labels, packaging and instructions for use

•Handling Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities



EC REP Responsibilities, cont’d.

•Representing you before the European Commission in the event that your product is withdrawn in a member state

•Protecting the confidentiality of your product information

•Maintaining reports on clinical evaluation data for review by Competent Authorities

•Communicating with Competent Authorities on serious device incidents or FSCAs



Step Five: Notified Body Audit

Class I Sterile/Measuring


Following appointment of your EC REP, your quality system and Technical File/Design Dossier must be audited by a Notified Body. Upon Successful

completion of your audit, the Notified Body will issue a CE Certificate.



Notified Body Audit, cont’d.

• Manufacturers of Class I Non-sterile/Non-measuring devices self-declare MDD conformity and do not require CE Marking certificates.



Step Six: Registration with Competent Authorities

Class I Sterile/Measuring Class I Non-Sterile/Non-Measuring

Class I device manufacturers must register with the Competent Authority of the country where their EC REPs are based.



Registration with Competent Authorities, cont’d.


Some EU member states do not require registration of Class IIa, IIb or III devices with Competent Authorities. Other countries do not require registration of devices.



Step Seven: Declaration of Conformity and CE Marking

In order to complete the CE Marking process, all manufacturers must prepare a Declaration of Conformity stating their device is in compliance with all applicable Directives. Upon completion of your Declaration of Conformity, you may affix CE Marking to your product.



Declaration of Conformity, cont’d.

Product identification

Manufacturer identification

EC REP information

Applicable Directives



Labeling and Language Requirements

EU member states MAY REQUIRE labeling information be made available in their local languages or another European Community language to patients and users

in accordance with Annex I, point 13 of the MDD.



Labeling and Language, cont’d.

Language Requirements

All languages subject to subsidiarity

All EU member states require device labeling in their official languages

Label information in your Technical File should only appear in ONE language



Post-Market Surveillance (PMS) and Vigilance

• PMS required for all medical devices sold in the EU

• Manufacturers are required to develop proactive plans for PMS

• PMS plans should include reviews of market and field data, complaints and corrective actions

• Systematic records of PMS findings must be kept



Post-Market Surveillance and Vigilance, cont’d.

Purpose of Vigilance Requirements

•Protecting public health and safety

•Evaluating incidents to prevent recurrence

•Determining effectiveness of corrective actions taken

•Monitoring and learning from experience



Post-Market Surveillance and Vigilance, cont’d.

Vigilance Requirements for Manufacturers:

• Establish and maintain systematic procedures to review experience gained from devices in the post-production phase

• Implement appropriate means to apply any necessary corrective actions



Additional Resources Emergo Group services for Europe:

http://www.emergogroup.com/services/europe

Regulatory process charts:

http://www.emergogroup.com/literature

European medical device regulations:

http://www.emergogroup.com/resources/regulations-europe

11-minute video explaining the CE Marking process for medical devices

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

Upcoming webinars from Emergo Group:

http://www.emergogroup.com/webinars

Previously recorded webinars available to view anytime:

http://www.emergogroup.com/videos

Want more information or a proposal? Contact any of our worldwide offices.

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