Medical Device & QA Consultancy

CUSTOMER SUPPORT SERVICES

Authorized Representative Issues

Article 14 of the Directive

Article 14 amended by the IVD

Changing to an Alternative Authorized Representative

Definition of Authorized Representative

Definition of Authorized Representative, as amended by the IVD

Distributor acting as Authorized Representative

Label, the requirements of

Need for an Authorized Representative

Reporting path between the Manufacturer and the Competent Authority

Reporting Path Flow Chart

Role of the Authorized Representative

Selecting an Authorized Representative

Return to our HOME PAGE E-mail: bernardt@mdqaconsultancy.co.uk

Introduction

There are many misunderstandings and myths surrounding exactly who represents the manufacturer in Europe, when the manufacturer himself is based outside the European Community. The exact role and the responsibilities of the ‘manufacturers representative’ are not clear either, therefore one of the objectives of this chapter is to clear up this confusion so that manufacturers based outside the European Community can make informed decisions and ensure that their best interests are served at all times.

The term ‘authorized representative’ has different meanings and therefore different responsibilities under other directives. For example the Machinery, Low Voltage and certain other directives mention the role of the authorized representative, but these are outside the scope of this publication. But in the context of the Medical Device directive 93/42/EEC, the authorized representative has a special and particular role to play.

The medical device directive’s definition of the ‘authorized representative’

The term ‘manufacturer or his authorized representative’ is referenced 18 or so times in the medical device directive itself, but astonishingly, it is not defined in Article 1 of the directive. Article 1 of the directive is the section which deals with definitions. Various terms referred to in the directive are defined, such as ‘the manufacturer’, ‘placing on the market’ and most importantly a ‘medical device’, but a definition of the ‘authorized representative’ has been omitted.

For completeness, the following table lists all the annexes and articles of the directive, where a reference is made to the ‘authorized representative’.

Articles and Annexes of the medical device directive 93/42/EEC that are relevant to the Authorised Representative

· Articles 8 - Safeguard Clause issues

· Article 10 - Adverse Incident Reporting responsibilities

· Article 11 - Co-operation with Notified Body in Conformity Assessment issues.

· Article 14 - Registration of Person Responsible for "Placing on the Market".

· Article 15 - Clinical Investigation issues

· Article 16 - Co-operation with Notified body on time limits etc

· Article 18 - Co-operation with Notified Body and Competent Authority in "Wrongly Affixed CE Marking" issues.

· Article 19 - To represent the Company 's interests in decisions of Refusal or Restriction

· Article 21 - Represent the Company in matters concerning the Repeal & Amendment of related Directives.

· Annex I - To ensure that the Company meets all it's responsibilities under ER #'s 13.3 and 13. 6., Labelling and Instructions for Use.

· Annex III & IV - To represent the Company's interests, where appropriate.

· Annexes II, IV, V, VI, VII and VIII - To represent the Company's interests in the appropriate Conformity Assessment routes

· Annex X - To represent the Company's interests.

The authorized representative

The basic need to have an ‘authorized representative’ arises because, where a manufacturer is based outside the European Community, the Competent Authorities need to be able to contact an entity or person who is based within the European Community, and who acts on behalf of the manufacturer.

There are three terms within the directive, which have an impact when the manufacturer is based outside the European Community. These are the ‘authorized representative’, ‘the person responsible for placing products on the market’ and ‘the importer’.

Where manufacturers are based outside the European Community, there is a sound argument for differentiating between the regulatory (including product safety) issues and the marketing issues involved in selling product in Europe. Marketing people generally have sales targets and market share issues to keep them occupied, whilst compliance with the regulatory issues requires a separate and special focus, to keep the Company on the right side of the regulation. Most, but not all, companies do differentiate between the two issues and appoint separate entities to execute the two functions. However, it must be said that the marketing and the regulatory issues can be executed by one entity, if the manufacturer so wishes.

Article 14

Article 14 is entitled 'registration of persons responsible for placing devices on the market' and is the directive's requirement for the manufacturer of class I devices and procedure packs to inform relevant Competent Authorities of certain information. According to article 14, the details required from the manufacturer are;

· the address of the registered place of business and

· a description of the devices

This information has to given to the "competent authorities in the member state in which the person responsible has their registered place of business". Therefore, this implies that registration only needs to be carried out once. In reality, some competent authorities are requiring registration of all devices of all Classes, not just Class I.

The article goes on to state in clause 2 that where the manufacturer is based outside Europe, that the exact same requirements apply to the designated [by the manufacturer] person responsible for marketing.

Clearly, a hierarchical structure is emerging, which can be summarised as follows;

MANUFACTURER

Designates an entity to act on their behalf when addressing authorities and bodies

The 'entity' can be either

the person responsible for marketing the devices

the authorized representative of the manufacturer established within the community

the importer established within the community

or or

The manufacturer and the manufacturers representative's name on the Label

Accurate labelling of all medical devices is of the utmost importance, not least because the directive states that a product recall could become necessary because of "...any inadequacy in the labelling or the instructions for use..." (Annex VII Clause 4 ( i ). The labelling criteria for all medical devices is set out in Annex I (Essential Requirements) of the directive, under Essential Requirement number # 13.3. The particular requirements for the manufacturer and the 'manufacturers representative' are contained in sub requirement (a) of 'essential requirement' number 13.3. This 'essential requirement' reads as follows;

"...the label must bear the name or trade name and address of the manufacturer. For devices imported into the community, in view of their distribution within the community, the label, or the outer packaging, or the 'instructions for use', shall contain in addition the name and address of either;

· the person responsible [for marketing the devices], or of

· the authorized representative of the manufacturer established within the community, or of

· the importer established within the community,

as appropriate...".

Summary of the requirements of the 'Label'.

Labelling is the collective term which refers to;

· the actual Label itself, which would normally be affixed to the medical device

· the 'outer packaging'

· the 'Instructions for Use'

· any 'product inserts'

The medical device directives requirements for the Label are set out in Essential Requirement # 13.3. The particular requirement for information regarding the manufacturer is contained in clause (a) of Essential Requirement # 13.3.

Where the manufacturer is located outside the European Community, the clause requires that;

"...the label, the outer packaging or the instructions for use, shall contain the name and address of either the person responsible for marketing the devices or the authorized representative of the manufacturer established within the Community or of the importer..."

The above requirement can be simplified as follows;

PRODUCT LABEL

INSTRUCTIONS FOR USE

PRODUCT INSERTS

OUTER PACKAGING

The or the or any or the

must contain either;

(1) - The NAME OF THE PERSON RESPONSIBLE FOR MARKETING

or;

(2) - The AUTHORIZED REPRESENTATIVE OF THE MANUFACTURER ESTABLISHED WITHIN THE COMMUNITY

or;

(3) - The IMPORTER ESTABLISHED WITHIN THE COMMUNITY

Amended definition of ‘authorized representative’.

As previously stated, the medical device directive 93/42/EEC does not define the role or responsibilities of the authorized representative. The medical device directive entered into force in June 1995, but it was not until 3 years later that the role of the authorized representative was actually defined.

The entry into force of the In vitro diagnostics directive (IVD) (98/79/EC) in December of 1998, did at last provide a definition of the ‘authorized representative’. In Article 21 ( j ) of directive 98/79/EC, which retrospectively amends the medical device directive, the following definition is given;

‘authorized representative’ – means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer, with regard to the latter’s obligations under this directive.

Role of an authorized representative

It is very important for any manufacturer to clearly define in their Standard Operating Procedures (SOP's) covering Post Sales Issues, the exact responsibilities and reporting paths for all activities. FIG 1 illustrates typical reporting paths. The following Post Sales Issues could all involve the authorized representative, dependent on the manufacturers preference and just how the system had been set up;

• Customer Complaint Handling

• Adverse Incident Reporting

• Product Recall

• Post Market Feedback

Of the above issues, the authorized representative's involvement in Post Market Feedback and Product Recall would be optional. However, the authorized representative would certainly be involved in Customer Complaint Handling and Adverse Incident Reporting. Not least because the authorized representative's name and address would be on either the Label itself or the IFU, or possibly both. Any user then requiring to make a complaint, would naturally direct the complaint to the entity displayed on the Label or in the Instructions for Use (IFU).

So, the manufacturer would need to define and document in their procedures, the reporting path for Customer Complaints, should a complaint be received by the authorized representative.

The contract between the authorized representative and the manufacturer should clearly and unambiguously assign responsibilities for all activities.

Complaints could also be fed back to the manufacturer or the authorized representative by way of distributors. Therefore, a contract between a distributor and the manufacturer, besides dealing with marketing issues, should make clear the reporting paths and responsibilities for these issues. FIG 1 illustrates the main issues to be considered, along with typical reporting paths.

Reporting paths of FIG 1

There are two possibilities regarding the reporting of reportable incidents. Firstly, that when the authorized representative receives a Customer Complaint that meets the Reporting Criteria, the authorized representative then reports direct to relevant Competent Authorities, without prior consultation with the manufacturer. Parallel reporting back to the manufacturer would be essential in this scenario.

The second possibility is that the authorized representative feeds back all Customer Complaints to the manufacturer so that the manufacturer, through their Corrective Action system, can make a judgement on whether or not the reporting criteria has been met. The reporting path to the competent authority could then be either direct or through the authorized representative. If the former is the case, then parallel reporting would be necessary to the authorized representative, to keep him aware of the situation.

In most medium to large sized companies, where a mature Quality Management System would be in place, the direct reporting path to the competent authority, with parallel reporting to the authorized representative, would be the preferred option. This would enable the manufacturer to exercise complete control over the judgement as to whether or not the reporting criteria had been met, and whether or not the consequent reporting to relevant competent authorities was necessary.

The former option, where the authorized representative exercises the control and judgement on which incidents to report, might be appropriate for a very small company, which needed to rely on the expertise of a third party, where regulatory issues are concerned.

If the former option is chosen, it is imperative that the manufacturer is fully involved every step of the way, as the manufacturer has the final responsibility for all issues.

Therefore, it must be restated that the responsibilities and reporting paths of FIG 1 need to be established, documented and if necessary, included within contracts or agreements.

Reporting criteria

There are two kinds of reportable incident;

Adverse Incident - an incident that caused the death or serious deterioration in the health of a patient, user or other person,

Near Incident - an incident that might have caused the death or serious deterioration in the health of a patient, user or other person,

It is important to differentiate between the above two types of Reportable Incident, because there are different reporting times. Ten (10) days for an Incident and thirty (30) days for a Near Incident.

These definitions should be included within the manufacturers Corrective Action procedures and the persons responsible should be trained accordingly. Records should be kept of this training.

In accordance with FDA 21 CFR 820.25 requirements, these persons should additionally be trained to understand the consequences of a failure to implement the procedures correctly.

Responsibilities of the authorized representative

The authorized representative's responsibilities could be separated into two categories; namely 'minimum regulatory responsibilities' and 'additional responsibilities'.

Minimum regulatory responsibilities

The minimum service that any authorized representative offers should include the following issues. Referring to FIG 1, the authorized representative would be involved in receiving Customer Complaints from Customers themselves or from distributors, and feeding back that information into the manufacturer's Corrective Action system.

Additionally, registering the manufacturers products with appropriate Competent Authorities and holding a copy of the Technical File, to be provided to a Competent Authority on request, are important issues to be addressed. If the authorized representative holds a copy of the Technical File, then the manufacturers quality management system document control needs to extend to the Technical File copy held by the authorized representative. This change notification requirement ought to be part of the agreement between the manufacturer and the authorized representative.

In cases where the authorized representative does not hold a copy of the Technical File, then the agreement needs to ensure that the manufacturer will supply a copy of the Technical File to either the authorized representative or/and the Competent Authority, within 7 days of a request.

Significant change notification

Where significant changes occur to either the manufacturers quality management system or product range, (FIG 1 block C) then provision needs to be made to inform the authorized representative when such changes occur. Again, this requirement should be part of the agreement between the authorized representative and the manufacturer.

One of the most important responsibilities of the authorized representative is to 'act and to [may] be addressed by authorities and bodies in the Community instead of the manufacturer, with regard to the latter’s obligations under this directive', (see 'amended definition of authorized representative' earlier in this chapter). This is an important function and can involve simply communicating verbally or in writing with Competent Authorities or in extreme cases, making an actual visit. Issues that may fall within this scope could be for example, device classification issues (where an error in classifying a device had been discovered), issues involving product recall or possibly where a product's performance had been called into question.

Another very important issue is that of product recall. Such an issue would generally be controlled from the manufacturers facility outside Europe, but it would be sensible to involve the authorized representative, not least because of his closer proximity to the installed base of product.

One final consideration is where the manufacturers products are of an 'Implantable' nature. An Implantable medical device, according to Section I of Annex IX (Classification criteria) of the medical device directive 93/42/EEC is as follows;

Any device which is intended;

- to be totally introduced into the human body or,

- to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days, is also considered an Implantable device.

In addition to the requirements that EN 46000 imposes on all medical devices, there are particular additional requirements for 'Implantable Medical Devices'. One requirement in particular is Clause 4.15.6 which deals with 'Delivery' of product. The requirement is as follows;

"The [manufacturer] supplier shall require that any authorized representative maintains records of distribution of medical devices and that such records are available for inspection"

Optional responsibilities

An authorized representative service may also include the following issues. Referring to FIG 1, the authorized representative may also be involved in researching Clinical, Medical, Regulatory or Standards requirements and feeding these back to the manufacturer, as part of the agreement between the manufacturer and the authorized representative.

Additionally, the authorized representative may be involved in implementing the manufacturers Post Market Feedback system. This is the means by which the manufacturer evaluates the performance of their product, in the post sales phase, in accordance with a generic documented procedure. This procedure would incorporate the following elements;

· would be product based

· would be invoked for a particular purpose, for example:

- to verify the design of the product

- to validate a new intended purpose for an existing device

- to validate customer satisfaction,

- to meet regulatory and vigilance requirements

· would have the data sources defined, to include proactive and reactive sources,

Examples of reactive sources:

- Customer Complaints, Service Reports, Returned Product etc

Examples of proactive sources:

- Distributor and/or Customer questionnaires, Marketing Department data, information on competitor or similar products, etc

· would provide for review of the gathered data,

The review should be by a designated person and documentary evidence of that review should be recorded.

· determination of necessary resulting actions.

Once the data had been gathered, reviewed and analysed, the final step in the process would be to determine and implement any necessary resulting actions. These might include;

- Changes to the design of the product,

- Significant Change notification, if necessary,

- Reporting of an incident which meets the reporting criteria.

- Retraining of personnel

- Changes to quality management system procedures or work instructions.

The procedure should also make provision to review the process at defined intervals. In addition, the procedure should provide for a review of the Post Market Feedback System itself, to ensure it's continuing suitability in meeting the 'purpose ' for which the procedure was invoked in the first place.