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

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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.

Selecting an authorized representative

The manufacturer has to determine his basic needs before committing to a particular authorized representative. Some authorized representative's offer a very wide range of authorized representative Service. Others offer a service far in excess of that required by the directive. Generally, the more wide ranging the service, the higher the fee.

The considerations are whether the manufacturers needs require an authorized representative to provide just the minimum regulatory requirement covering Post Sales Issues or whether additionally Pre Sales Issues such as design of new product, advice on changing regulatory and standards requirements etc need to be included.

Typical authorized representative service

As a minimum, any authorized representative service should include involvement in all the Post Sales Issues of ;

· Incident Reporting,

· Product Recall,

· Complaint Handling, and

· Post Market Feedback.

Additionally, the chosen authorized representative should have the competency to be able 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), as and when required, for example;

· Registering Class I devices with relevant competent authorities

· Notifying Significant Changes to appropriate bodies

· Classification or product performance issues

· Hold the technical file for inspection by the authorities or be the conduit, by which the

Technical File is delivered to the authorities, as required

It is not absolutely necessary for the authorized representative to be totally familiar with the manufacturers particular products, but an authorized representative with experience of a wide range of products, is more likely to be able to serve the manufacturers best interests.

An important area where an experienced authorized representative would be of benefit to a manufacturer, is where Class I devices were involved. Because of the Self Certification nature of Class I devices, where the product is not a measuring device and is not supplied sterile, it is important to apply the Classification procedure effectively, because there is no third party verification of either the Technical File content or the appropriateness of the chosen conformance route.

In order to provide an effective service, an authorized Representative should also be able to advise a manufacturer on all of the above issues. To be able to be fully effective, the authorized representative should have some means of keeping abreast of current developments and to be aware of new interpretations of existing requirements, as they occur.

For example, the author of this chapter offers two kinds of authorized representative service. A Standard Service covering the basic regulatory Post Sales Issues mentioned above and a tailor made Premium Service covering additionally any Pre Sales Issues such as Design Control, Product Safety and New Product Development, that are of interest to the manufacturer.

Changing to an alternative authorized representative

A manufacturer may decide to change their authorized representative for a variety of reasons. Their authorized representative may cease to trade or the manufacturer may not feel that they are receiving value for money or the manufacturer may simply feel that their best regulatory interests are not being professionally looked after.

Either way, the task of choosing an alternative authorized representative is somewhat similar to changing Notified Bodies; it can be achieved quite simply and effectively. The main consideration would be the termination clause in the Contract or Agreement between the manufacturer and their existing authorized representative.

Implications of changing authorized representative

The following areas need to be considered;

· Authorized representative's name on Label and or Instructions for Use and/or sales Literature

· Significant Change notification

· Post Sales procedures

· Manufacturers indemnity insurance

· Might be part of distributor network

The authorized representative's name and address could be on any or all of the Label itself, Instructions for Use, Product Inserts, as well as Sales and Marketing Literature. These would all have to be changed to reflect the new authorized representative service being used. Product already on the market, with the previous authorized representative's details would not need to be retrospectively changed to reflect the new authorized representative. However, consideration would need to be given to the fact that product was on the market, with the name and address details of an entity who was no longer the authorized representative of the manufacturer.

The change of authorized representative would be a 'Significant Change' (block C of FIG 1) and would therefore require notification to the manufacturers notified body and also to relevant competent authorities, where Class I devices had been registered.

Some authorized representative's offer two kinds of Service.

An authorized representative who had a wide experience of Medical Device Compliance strategies would be able to offer both Post Sales Regulatory coverage and Pre Sales help and advice.

Medical Device & QA Services offers a painless and seamless transition for those Device Manufacturers who have identified the need to move from their existing Authorized Representative to a New One. Procedures to enable the transition to be both seamless and simple are available as part of our Authorized Representative Package and Unlimited assistance is given on all related matters. Please e-mail bernardt@mdqaconsultancy.co.uk for a quotation or telephone +44 161 980 4310 to discuss your requirements.

Summary of considerations when selecting an authorized representative

As discussed previously, the Importer or Distributor may act as the Authorized Representative of any Company that does not have a permanent base within Europe. Some Companies do appoint their Distributor to act as their Authorized Representative, but others realize that the Sales and Marketing responsibilities, for example;

· Identifying new Customers

· Increasing Market Share

· Identifying areas into which the Company can diversify

· Ensuring that existing Customers remain satisfied and loyal

· plus a multitude of other Sales and Marketing issues….

Distributor acting as the authorized representative - The main consideration is whether or not an existing distributor of a manufacturers products can effectively fulfil the regulatory responsibilities alongside their marketing activities. Only the manufacturer can decide, taking full account of the issues already discussed and the following;

· how long has the prospective authorized representative been in the health care industry ?

· do they have a demonstrable track record ?

· can they supply references from existing manufacturers for whom they are supplying the same service ?

· can they demonstrate sufficient knowledge of the medical device directive (93/42/EEC) itself ?

· can they advise accurately on all the Regulatory issues of Labelling, including The Label itself, Product Inserts, Inner and Outer Packaging, Instructions for Use and Advertising etc etc ?

· can they demonstrate sufficient knowledge of the ISO 9000 series of standards ?

· can they demonstrate knowledge of the additional requirements of the EN 46000 and ISO 13485 series of standards, including the new ISO 9001:2000 ?

· are they prepared to be responsible for the additional Implantable requirements, if appropriate ?

· are they committed to continuous improvement of the service that they provide ?

· are they committed to keeping abreast of developments and changes in the regulatory requirements ?

· can they provide advice and guidance on parallel issues such as the Packaging and the Packaging Waste Directive, Electrical and Electronic Waste Directive and the ISO 9000 year 2000 revisions etc ?

· can they help organise or control distributors, if required.

· can they advise on effective implementation of all Regulatory Procedures, including Adverse and Near Incident Reporting, Advisory Notice Issue (including Product Recall), Post Market Feedback, Complaint Handling and Significant Change Notifications ?

· are they prepared to participate fully, if required, in all Post Sales Issues (Post Market Feedback, Incident Reporting, Product Recall and Complaint Handling) ?

One final consideration

Currently, there are different requirements in some European Countries, concerning the registration procedures of Class I devices and Systems and Procedure Packs. Therefore, the entity (distributor, importer or authorized representative) that the manufacturer has designated to 'act [on the manufacturers behalf] and [to] 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), needs to be cognisant of the differing Country specific requirements.

To reiterate, Article 14 of the medical device directive 93/42/EEC requires the registration of Class 1 devices. But, in practice some competent authorities require registration of all Classes of device. The safest way for the time being is to register all devices with the competent authority of each Country to which product will ship. When the IVD directive is in force, then it will only be necessary to report to one competent authority.

Paragraph 3 of Article 14 of the medical device directive concerns sharing of details by competent authorities, and is reproduced here for information;

3. The Member States shall on request inform the other Member States and the Commission of the details referred to in paragraphs 1 and 2 [namely, the address of the registered place of business and a description of the devices].

This was an early attempt by the European Commission to establish a European wide database of medical devices of all classes that had been placed on the market.

However, this extremely useful concept, which would eventually preclude the need to report to multiple competent authorities, did not progress beyond the concept stage. Again, it was left to the publication of the IVD Directive to map out the way forward.

Appendix to Article 14

When the IVD Directive comes into force in June 2000, an appendix to Article 14 titled "European data bank" (Article 14 (a)) will apply to the medical device directive 93/42/EEC. The text is reproduced here;

1. Regulatory data in accordance with [ the medical device directive 93/42/EEC] shall be stored in a European database accessible to the competent authorities to enable them to carry out their tasks relating to [ the medical device directive 93/42/EEC] on a well informed basis.

The data bank shall contain the following;

(a) data relating to registration of manufacturers and devices in accordance with article 14 [of the medical device directive 93/542/EEC].

(b) Data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the [conformance] procedures laid down in Annexes II to VII.

(c) Data obtained in accordance with the vigilance procedure, as defined in Article 10 [of the IVD directive 98/79/EC].

2. Data shall be forwarded in a standardised format.

So clearly, we have the beginnings of a Europe wide database of all manufacturers and their devices, which can only be of benefit to all concerned, and in particular the manufacture's authorized representative {or the distributor, importer or person responsible for marketing), as appropriate.

And finally, a reiteration of the latest interpretation of the most important definition of all;

What Additional Fees Might Be Applicable to an Agreement with M.D. & QA Services to Provide Authorized Representative Services?

Unlike some providers of AR services, we do not make an up front or regular charge for the number of Incidents that are reported or even Product Recalls that your Company might become involved in.

Instead, we would include our time involved in such issues, within the Free Of Charge monthly Regulatory Support Time, that is part of our Agreement.

We prefer to represent your interests in a professional and honest manner at all times, charging a standard fixed All Inclusive fee that is fixed for three years and is both fair to your company and to ours.

If the occasion should arise where we need to become involved in reporting an Incident or in Recalling product, then the One Hour per Month ‘free of charge Support’ that is part of our AR agreement, would be extended to 3 hours, in order to facilitate reporting of the Incident or Recalling the Product, with no additional cost to your company.

Thereafter, any additional costs would be negotiated at the time, and our special reduced hourly rates would be applicable, as an existing client.