Principles of Conformity Assessment for Medical Devices

Principles of Conformity Assessment for Medical Devices . 1.0 Purpose. ... that a medical device is safe and performs as intended by the manufacturer ...

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Principles of Conformity Assessment for Medical Devices 1.0 Purpose To describe: · the evidence and procedures that may be used by the manufacturer to demonstrate that a medical device is safe and performs as intended by the manufacturer and conforms to the Essential Principles of Safety and Performance for Medical Devices; · the conformity assessment elements that should apply to each class of device such that the regulatory demands increase with the risk class of the medical device; · the process by which MDB, or CAB appointed by or acting on behalf of MDB, may confirm that such elements are properly applied by the manufacturer; and · the manufacturer’s written attestation that it has correctly applied the conformity assessment elements relevant to the classification of the device, i.e. the ‘Declaration of Conformity’. 2.0 Scope This document applies to all products that fall within the definition of a medical device, other than those used for the in vitro examination of specimens derived from the human body, and to the activities of the medical device manufacturer. The conformity assessment principles are based on the GHTF documents.

3.0 Conformity Assessment Elements The conformity assessment elements that the MDB may make available to the manufacturer will include: a quality management system, a system for post-market surveillance, summary technical documentation, a declaration of conformity and the registration of manufacturers and their medical devices by the MDB. All five elements are required for each of the device classes. Where there are alternatives within a conformity assessment element, the manufacturer may choose the one that it believes to be the most suitable. The conformity assessment elements that appear in this Section describe the tasks of the manufacturer and, where appropriate, the responsibilities of the MDB or CAB. Specific guidance on the conformity assessment elements for each device class is provided in the tables in Section 4.2.

3.1 Conformity assessment of the quality management system 3.1.1 Quality management system The requirements for a quality management system that is accepted by MDB for regulatory purposes and based on international recognised standards, combined with the other conformity assessment elements are intended to ensure that medical devices will be safe and perform as intended by the manufacturer. A manufacturer needs to demonstrate its ability to provide medical devices that consistently meet both customer and regulatory requirements. Manufacturers demonstrate compliance through an established and effectively implemented quality management system that meets the regulatory requirements. The scope and complexity of the quality management system that a manufacturer needs to establish is influenced by varying needs, objectives, the products provided, processes employed, the size and structure of the organisation, and the specific regulatory requirements. Processes required by the quality management system but carried out on the manufacturer’s behalf by third parties remain the responsibility of the manufacturer and are subject to control under the manufacturer’s quality management system. As part of the MDB/CAB’s conformity assessment process, they should assess the adequacy of this control. Conformity assessment of the manufacturer’s quality management system is influenced by the class of the medical device. For Class B, C and D devices, the MDB or CAB needs to be satisfied that the manufacturer has an effective quality management system in place, appropriate for the device under assessment. In doing this, the MDB or CAB will consider any relevant existing certification and, if not satisfied, e.g. with its scope or with post-market performance history, may carry out an on-site audit of the manufacturer’s facility. Manufacturers of Class C and D devices should have a full quality management system 1 that includes design and development. Manufacturers of Class B devices should have a quality management system also; however, the procedures incorporated within it may not include design and development activities. Manufacturers of Class A devices are expected to have the basic elements of a QMS in place but need not include design and development activities. The QMS for manufacturers of Class A devices is normally not subject to premarket on-site audit by the MDB or CAB.                                                              1

See GHTF/SG3 guidance documents

In some jurisdictions, regulatory requirements permit exclusion of design and development activities from the scope of the manufacturer’s QMS. Although a full QMS is preferred, some country or regional regulations may allow the manufacturer to choose type examination 2 as an alternative means of demonstrating conformity with the relevant Essential Principles of safety and performance. Quality management systems are preferred because they implement a full cycle of design and development controls to ensure that medical devices comply with the relevant Essential Principles of safety and performance. For products that are in existence at the time of establishment of a QMS, evidence of design control and the resulting outputs would be difficult for the manufacturer to demonstrate retrospectively. In these circumstances, the manufacturer may request a CAB, in jurisdictions where such is permitted, to conduct a type examination to verify conformity with the relevant Essential Principles and to establish a baseline for entry into the design and development cycle. It is expected that for future design changes to this product, originally assessed for conformity by type examination, or for the introduction of a new product, the manufacturer would introduce the full design and development controls of the QMS. If the manufacturer chooses to use type examination by a CAB this will be indicated as such in the technical documentation and/or CSDT. The use of type examination does not replace the need to establish and maintain a production QMS. Type examination should never be imposed on a manufacturer by MDB. 3.1.2 System for post-market surveillance Prior to placing the product on the market, the manufacturer will put in place, as part of its quality management system, a process to assess the continued conformity of the device to the Essential Principles of Safety and Performance through the postmarketing phase. This process will include complaint handling, post-market vigilance reporting and corrective & preventive actions 3 . The MDB or CAB will confirm that such a process is in place, usually at the time of the quality management system audit 4 .                                                              2  ‘Type examination’ is a means of demonstrating compliance with relevant Essential Principles of Safety  and Performance of Medical Devices.  One or more representative units of the device (i.e. the “type”)  chosen by the manufacturer (e.g. final prototypes representative of the production configuration),  together with relevant technical documentation, are submitted to a comprehensive examination by a  CAB to confirm compliance.    3 4

See GHTF/SG2 guidance documents. Further details are provided in the GHTF guidance documents issued by Study Groups 3 and 4.

3.2 Conformity assessment of device safety and performance 3.2.1 Summary technical documentation The technical documentation provides the evidence used in the conformity assessment process. For the purposes of conformity assessment, the manufacturer will establish a subset of technical documentation to be held or submitted to MDB or CAB, as required by the class of the device. A description of that subset is provided in the proposed GHTF guidance document: Common Submission Dossier Template for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (CSDT). The extent of evidence in that CSDT is likely to increase with the risk class of the medical device, its complexity and the extent to which it incorporates new technology. The MDB or CAB determines the adequacy of the documented evidence in support of the manufacturer’s attestation of conformity to the essential principles of safety and performance through a review of the CSDT. The depth and timing of the review is likely to be influenced by the risk class of the medical device, its complexity and the extent to which it incorporates new technology. 3.2.2 Declaration of conformity One element of a global regulatory model for medical devices is that the manufacturer attests that its medical device complies fully with all applicable Essential Principles for Safety and Performance and draws up a written ‘Declaration of Conformity’. As a minimum, this declaration should contain the following information: •

• • • • • • •

An attestation that each device that is subject to the declaration: ¾ complies with the applicable Essential Principles for Safety and Performance, ¾ has been classified according to the classification rules, and ¾ has met all the applicable conformity assessment elements. Information sufficient to identify the device/s to which the Declaration of Conformity applies. The Global Medical Device Nomenclature (GMDN) code and term for the device. The risk class allocated to the device/s after following the guidance found in Principles of Medical Devices Classification. Which of the conformity assessment elements described in Section 3 have been applied. The date from which the Declaration of Conformity is valid. The name and address of the device manufacturer. The name, position and signature of the responsible person who has been authorised to complete the Declaration of Conformity upon the manufacturer’s behalf.

The MDB or CAB may review and confirm the adequacy of the Declaration of Conformity, if required, by examining the supporting documents or other evidence. 3.3 Registration 3.3.1 Registration of manufacturers and their medical devices by the Regulatory Authority Registration of manufacturers and their medical devices by the MDB is considered to be the most basic level of regulatory control of devices in the market. This registration system will identify the device/s and the party responsible for the device/s within the particular jurisdiction, thereby facilitating any regulatory activity. Prior to placing a medical device on the market, the manufacturer, its local distributor or its Authorized Representative should provide the Authority with the required information. The MDB will maintain the register. 4

Harmonized Conformity Assessment System

4.1 The relationship between conformity assessment and device classification The MDB recommends that each medical device be allocated to one of four risk classes, using a set of rules. Class A devices are the lowest risk devices, Classes B are moderate to low risk, Class C are moderate to high risk and Class D devices present the highest risk. The level of scrutiny, evidence requirements that the device meets the Essential Principles for Safety and Performance and conformity assessment elements become more robust and demanding as the risk class of the device increases. This principle is illustrated in the guidance that follows. It identifies available conformity assessment elements and proposes a combination of those elements that may be applied to different classes of medical devices to construct a harmonized conformity assessment system that may be adopted as part of a global regulatory model for medical devices. Where there are alternatives within a conformity assessment element, e.g. the quality management system for a Class A device may be either a full quality management system or one without design and development control, the manufacturer may choose the one that it believes to be most suitable. 4.2 Conformity assessment system The four tables below summarise conformity assessment elements that apply to Class A, B, C and D devices.

CLASS A DEVICE

Conformity Assessment Element Quality Management System (QMS)

Manufacturer Responsibility

Establish and maintain a full QMS

or a QMS without design and development controls.

Conformity assessment of the QMS

Conformity assessment of device

performance

Registration

Section

Regulatory audit normally not required except in special cases, e.g. assurance of sterility & of measuring function/s.

3.1.1

Post-market Surveillance

Establish and maintain an adverse event reporting procedure according to GHTF SG2 guidance.

May audit post-market to investigate specific safety or regulatory concerns.

3.1.2

Technical Documentation

Prepare CSDT and have available for review by RA upon request.

Premarket submission of CSDT normally not requested.

3.2.1

Declaration of Conformity

Prepare, sign and maintain.

Submission normally not requested.

3.2.2

Registration of manufacturers and their devices

Perform according to regulatory requirements.

Maintain and verify as appropriate.

3.3.1

safety &

MDB / CAB Responsibility

CLASS B DEVICE

Conformity Assessment Element Quality Management System (QMS)

Manufacturer Responsibility

Establish and maintain a full QMS

or

Conformity assessment of the QMS

a QMS without design and development controls.

Be satisfied that a current and appropriate QMS is in place or otherwise conduct a QMS audit prior to marketing authorization.

3.1.1

Establish and maintain an adverse event reporting procedure according to GHTF SG2 guidance.

Be satisfied that a current and appropriate adverse event reporting procedure is in place as part of the QMS.

3.1.2

Technical Documentation

Prepare CSDT and have available for review upon request.

Not normally reviewed premarket. If submission is requested, receive and conduct a premarket review of the CSDT sufficient to determine conformity to Essential Principles.

3.2.1

Declaration of Conformity

Prepare, sign and make available for review.

Review and verify compliance with requirements.

3.2.2

Registration of manufacturers and their devices

Perform according to regulatory requirements.

Maintain and verify as appropriate.

3.3.1

safety

performance

Registration

SubClause

Post-market Surveillance

Conformity assessment of device

&

MDB / CAB Responsibility

CLASS C DEVICE

Conformity Assessment Element

Conformity assessment of the QMS

Conformity assessment of device safety &

Manufacturer Responsibility

MDB / CAB Responsibility

SubClause

Quality Management System (QMS)

Establish and maintain a full QMS.

Be satisfied that a current and appropriate QMS is in place or otherwise conduct a QMS audit prior to marketing authorization.

3.1.1

Post-market Surveillance

Establish and maintain an adverse event reporting procedure according to GHTF SG2 guidance.

Be satisfied that a current and appropriate adverse event reporting procedure is in place as part of the QMS.

3.1.2

Technical Documentation

Prepare and submit a CSDT for review.

Conduct a review, normally premarket, of the CSDT sufficient to determine conformity to Essential Principles.

3.2.1

Declaration of Conformity

Prepare, sign and submit.

Review and verify compliance with requirements.

3.2.2

Registration of manufacturers and their devices

Perform according to regulatory requirements.

Maintain and verify as appropriate.

3.3.1

performance

Registration

CLASS D DEVICE

Conformity assessment of the QMS

Conformity assessment of device

Conformity Assessment Element

Manufacturer Responsibility

MDB / CAB Responsibility

SubClause

Quality Management System (QMS)

Establish and maintain a full QMS.

Be satisfied that a current and appropriate QMS is in place or otherwise conduct a QMS audit prior to marketing authorization.

3.1.1

Post-market Surveillance

Establish and maintain an adverse event reporting procedure according to GHTF SG2 guidance.

Be satisfied that a current and appropriate adverse event reporting procedure is in place as part of the QMS.

3.1.2

Technical Documentation

Prepare and submit a CSDT for review.

Receive and conduct an in-depth premarket review of the CSDT to determine conformity to Essential Principles.

3.2.1

Declaration of Conformity

Prepare, sign and submit.

Review and verify compliance with requirements.

3.2.2

Registration of manufacturers and their devices

Perform according to regulatory requirements.

Maintain and verify as appropriate.

3.3.1

safety & performance

Registration

4.3 Conformity assessment considerations There are situations when characteristics of the device and/or its manufacturer may cause the MDB or CAB, by exception, to modify requirements relating to its conformity assessment. This may include deferring the review of the CSDT for Class C devices until a subsequent regulatory audit.

For example, MDB or CAB may exempt the manufacturer from making a complete premarket submission and/or require a less rigorous audit than would apply normally to a device of that class when: • the device incorporates well-established technology that is present in the market already; • the MDB and/or CAB is familiar with the manufacturer’s capabilities and its products; • the device is an updated version of a compliant device from the same manufacturer that contains little substantive change; • the MDB and/or CAB has particular experience with a comparable device; • internationally recognised standards 5 are available to cover the main aspects of the device and have been used by the manufacturer. Similarly, the MDB or CAB may require more detailed premarket submission and/or require a more rigorous audit and/or the provision of more clinical evidence than would apply normally to a device of that risk class when: • the device incorporates innovative technology; • an existing compliant device is being used for a new intended use; • the device is new to the manufacturer; • the device type tends to be associated with an excessive number of adverse events, including use errors; • the device incorporates innovative or potentially hazardous materials; • the device type raises specific public health concerns. It should be emphasised that there must be a fully justified and documented case before the MDB or CAB modifies in any way the relationship between device class and the associated conformity assessment element. Where there is justification for variation to the conformity assessment elements normally applicable to a particular device class, a statement in this regard should be included in the CSDT.

(Source : SG1-N40:2006)