Regulatory Approval Process for Medical Devices in EU - Presentation by Akshay Anand

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  • AKSHAY ANAND MI Year Master of Pharmacy

    Pharmaceutical Regulatory Affairs

    JSS College Of Pharmacy

    Mysuru 570015, Karnataka






    Medical Devices What are they? European Union An Overview EU Directives that impact Medical Devices Medical Devices as defined by EU Classification of Medical Devices as per EU The CE Certification The Registration Process for MD The Process Timeline for Registration


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    A medical device is an instrument, apparatus, implant, invitro reagent, or similar or related article that is used todiagnose, prevent, or treat disease or other conditions

    It does not achieve its purposes through chemical action withinor on the body.

    Medical devices vary greatly in complexity and application. The design of medical devices constitutes a major segment of

    the field of biomedical engineering. Examples range from simple devices such as tongue

    depressors, medical thermometers, and disposable gloves toadvanced devices such as computers which assist in theconduct of medical testing, implants, and prostheses.

    The global medical device market reached roughly $209 billionin 2006.


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    28 member states plus European Free Trade Association members.

    24 languages. Population of more than

    500 million people. GDP of $18.124 trillion. Euro, the currency

    equalling 71.47 Indian Rupee per unit.


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    Medical Devices (MDD) 93/42/EEC Covers the bulk of medical devices marketed in the EU Examples: orthopaedic 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


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    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

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    This guidance document under Directive 93/42/EEC on MedicalDevices provides definition of Medical Devices to include thefollowing:

    Medical Devices: Guidance Document

    MEDDEV 2.1/1 APRIL 1994

    a. Devices Accessoryb. Medical Purposec. Customizingd. Medical Toiletry Purposee. Aids for Handicapped Personsf. Softwareg. Multipurpose Products


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    The classification of medical devices is a risk based system based on thevulnerability of the human body taking account of the potential risksassociated with the devices.

    This approach allows the use of a set of criteria that can be combined invarious ways in order to determine classification, e.g. duration of contactwith the body, degree of invasiveness and local vs. systemic effect. Thesecriteria can then be applied to a vast range of different medical devicesand technologies.

    These are referred to as the classification rules and are set out in AnnexIX of Directive 93/42/EEC.

    Medical Devices: Guidance Document

    MEDDEV 2.4/1 Rev.8 JULY 2001

    MEDDEV 2.4/1 Rev.9 JUNE 2010


  • The CE mark, or formerly EC mark, is a mandatory conformity markingfor certain products sold within the European Economic Area (EEA) since1985.

    The CE marking is also found on products sold outside the EEA that aremanufactured in, or designed to be sold in, the EEA.

    This makes the CE marking recognizable worldwide even to people whoare not familiar with the European Economic Area.

    It is in that sense similar to the FCC Declaration of Conformity used oncertain electronic devices sold in the United States.

    It consists of the CE logo and, if applicable, the four digit identificationnumber of the notified body involved in the conformity assessmentprocedure.

    The CE marking is the manufacturer's declaration that the product meetsthe requirements of the applicable EC directives.



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    Manufacturers and Subcontractors

    Competent Authorities Notified Bodies Authorized Representatives Distributors

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

    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.

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    Notified Bodies are authorized to audit manufacturers quality systems and test/review devices for compliance with applicable EU Directives and standards.

    Their 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

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    Required for any firm without a location in the EU. Their responsibilities 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

    EC REP

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    Identify Directives and Regulations appropriate for your device

    Classify your device according to MDD Annex IX

    Implement Quality System in compliance with ISO 13485.

    Prepare Technical File or Design Dossier demonstratingcompliance with MDD 93/42/EEC.

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    Appoint your Authorized Representative.

    Have Notified Body audit your Quality Systemand Technical File or Design Dossier.

    Register your device with Competent Authorities if necessary.

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

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    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-SterileClass I Non-Measuring

    Class I SterileClass I Measuring

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

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    Class IIa

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

    Class IIbHigher-risk, often longer-term surgically invasive,

    sometimes implantable devices including intra-ocularlenses and surgical lasers

    Class IIIHighest-risk devices, including all active

    implantable devices such as replacement heartvalves and vascular stents

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    MDD 93/42/EEC Annex IX contains 18 rules for medical device classification based on factors including the following:

    Devices intended use Active versus non-active functionality Devices duration of contact with patient Degree of invasiveness Part of body contacted by device Special situations

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    Duration of Contact Criteria Less than 60 minutes = Transient Less than 30 days = Short-term More than 30 days = Long-term

    Degree of Invasiveness Criteria Application to body surface versus an orifice Surgically invasive or non-invasive Implantable

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

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    Short Term

    Long Term

    Long Term








    Class IIa

    Class IIb

    Class III

    Class I Sterile/Measuring

    Class I Non-Sterile/Non-Measuring

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    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.

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    Phase I: Quality system preparation and development Management buy-in Assign resources and staff Conduct gap analysis Develop quality manual and documentation controls

    Phase II: Implementation Employee training Internal auditing Corrective and preventative actions

    Phase III: Registration Registration audit performed by Notified Body Final ISO 13485 certification

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    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