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Sunday, September 19, 2010


Frequently asked questions about the role of the European Authorized representative for non-EU manufacturers of Medical Devices, In-Vitro Diagnostic Medical Devices and Machinery
1) Why do we need to select an Authorized Representative, if we are located outside Europe?

  • The Medical Device, IVDD and Machinery Driectives require all manufacturers not domiclied in the European Union to have an Authorized representative.2) What are our options?

  • You may select an agent, distributor, or independent Authorized Representative.3) How do we choose between an agent, distributor and an independent Authorized Representative?

  • Consider the following:

  • Do you want your distributor to focus on sales & marketing or on regulatory affairs?

  • Will your distributor in country A object if the name and address of your distributor in country B appears on all devices, inserts and packaging?

  • Will it lead to distribution/warranty confusion if the name and address of distributor A appears on your devices in all EU States?

  • If you change distributors will it be costly to change all device labels, inserts and packaging?

  • Do you feel comfortable having your distributor represent you in front of the Competent Authorities? The Competent Authority is the equivalent to the FDA for medical devices and OSHA for machinery in the USA.

  • If the Competent Authorities question an accident or a non-compliance that occurred in the distribution system will your distributor defend his company or yours?

  • If your distributor is unable to answer the Competent Authority's questions does anyone in your company have the knowledge to do so directly?

  • Are you comfortable placing a technical file containing design information with your distributor?

  • Do you feel that your distributor stays up to date on regulatory changes in Europe and will provide you with timely warning when changes affect your devices?4) Do independent Authorized Representatives sell medical devices or machinery in Europe?

  • No, they do not sell products; they do not compete with your distributors and/or agent.5) How do we select an Authorized Representative?

  • First you choose an Authorized Representative that is experienced and well versed in the areas of the related directives. Then you draw up an agreement clearly outlining the essential duties of the Authorized Representative in accordance with the requirements of the appropriate Directive.6) Which of the Authorized Representative's essential duties are listed in the Medical Device Directive and what should we ask for in addition?

  • Essential Duties required by Law:

  • Authorization to place its name, address, phone number on your device labels etc.

  • Acting as your primary contact point for the EU Authorities.

  • Registering of your Risk Class I devices with the Authorities before they are marketed.

  • Keeping your technical file documentation ready and available for the European Competent Authorities.

  • Protecting your documentation confidentiality because they are authorized to show them to the Competent Authorities only.

  • Notification of serious device incidents to the Competent Authorities Additional services you should ask for:

  • Assistance with technical file documentation including examples of procedures

  • Simplification of the Risk Analysis

  • Co-signing of the Declaration of Conformity

  • Annual review of your technical file

  • On-site visits

  • Notification of changes and amendments to the Medical Device Directive that affect your device(s).7) Why should the Authorized Representative sign the manufacturer's Declaration of Conformity?

  • The Declaration of Conformity clarifies who the European Authorized Representative is to any distributor, agent or other interested party.8) What does the Authorized Representative expect from us, the manufacturer?

  • Device compliance with the Medical Device Directive requirements.

  • Placing of your technical documentation in its trust.

  • Immediate notification of device incidents.

  • Full cooperation with requests from the Competent Authorities

  • Product Liability Insurance coverage that includes the EU.

  • Indemnification of product liability.9) Why do we need to place a partial technical file with our Authorized Representative in Europe?

  • To enable the Authorized Representative to respond to inquiries from the Competent Authorities within an allocated time period.10) How do we keep this technical file up to date?

  • An Authorized Representative should, at a minimum, provide you with an annual review of your technical file and remind you what to update. You should have access to your documentation in Europe when traveling for a personal review. Your Authorized Representative should visit your facility at regular intervals and assist you with the update.11) Is all the information that we place with the Authorized Representative confidential?

  • Confidentiality should be covered in the agreement between your company and the Authorized Representative in accordance with the Medical Device Directive which states that all parties, authorities included, are bound to observe confidentiality with regard to all information.12) What are the Authorized Representative's obligations and liabilities if the manufacturer's devices are not in compliance?

  • The Authorized Representative and the manufacturer are both obligated to end the infringement under conditions imposed by the member state such as: a letter of warning, penalty, sales ban etc.. Plus the producer i.e. manufacturer and other entity placing its name on the device, is liable for damages caused by defective devices. This is outlined in the product liability directive.13) Is product liability covered by the Authorized Representative agreement?

  • The product liability directive refers to any entity placing its name on the device. The medical device directive requires that the manufacturer plus the Authorized Representative names be printed on the device label, with the result that both parties are held liable. To prevent duplication of liability insurance for the same device the Authorized Representative becomes an additional insured under the manufacturer's worldwide policy.14) Why do Authorized Representative agreements include a penalty clause in case of a contractual violation by the manufacturer?

  • The Authorized Representative is subject to EU law. The device manufacturer however resides outside the EU Legal Jurisdiction and may decide not to cooperate with the EU authorities. To minimize the Authorized Representative's exposure of being on the receiving end of a manufacturer's liabilities, the penalty clauses provide recourse.15) If we cancel our Authorized Representative agreement do all duties stop immediately?

  • No, the Authorized Representative's name remains on devices already sold and still in use, resulting in the continuation of some obligations even after cancellation of the agreement.


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    1. This document is intended to be a guide for those manufacturers not located in the European Union or other countries forming the European Economic Area in their responsibilities for legal compliance with the requirements of the new approach directives listed below and the appointment of an Authorised Representative to act on their behalf. The Authorised Representative in the European Union, means a person established within the Community appointed by the manufacturer (whether or not established in the Community) to act on his behalf in fulfilling his obligations under the provisions of....... the directive being applied. This person must legally fulfil the role of retaining the conformity documentation and issuing the Declaration of Conformity (DoC) for products that carry the CE marking. In this position the person is known as the "responsible person". This person may also fulfil other responsibilities beyond that of being the responsible person. The actual person fulfilling this role can vary from someone specifically appointed to do this, to the importing agent, or even the user. It is also dependent on the directive being applied.

    2. For the purpose of this brief description the directives being considered have been confined to the following:
    EMC Directive
    Low Voltage Directive
    Machinery Directive
    Medical Devices Directive
    Radio and Telecommunication Terminal Equipment Directive

    3. In addition, consideration is also given to the role played by the Authorised Representative in the EU with respect to EC Type Examination and National Type Approval for certain product types.

    4. This review also covers the responsibility for retention of documentation and the role of the user if the manufacturer has not appointed an Authorised Representative in the EU. All reference to the European Union (EU) also includes the countries of the European Economic Area (EEA) and the old European Community (EC). This does not include Switzerland, which is not a member of the EU, EEA or EC.

    5. The general principles applied to being the discussion of the appointment of the Authorised Representative are applicable to all directives, but there are minor differences between directives and these will be highlighted.

    6. The EMC directive requires in Article 10 that the "manufacturer or his Authorised Representative established within the Community" issue a DoC and hold it at the disposal of the competent authority for ten years following the placing of the apparatus on the market. This has been interpreted by the European Commission to mean that should the manufacturer not be located in the European Union then he should appoint an "Authorised Representative" to issue the DoC on his behalf (alternatively he can produce the DoC, sign it and have the name of the Authorised Representative included on the document. In this case the Authorised Representative still issues it in the EU). Annex I of the Directive states that the DoC must identify the signatory empowered to bind the manufacturer or his authorised representative....... This means that the Authorised Representative must be legally bound by the signatory. Where the signatory is a manufacturer outside the EU, and where the manufacturer does not have a formally appointed Authorised Representative to act as his responsible person in the EU, then it becomes the person who supplies the equipment that is the responsible person. The responsible person is therefore simply the person who holds the documentation and issues the DoC in the EU. If he has other functions to perform, as with certain classes of medical devices then he must be appointed as the Authorised Representative. Where there is no formally appointed Authorised Representative, this becomes the importer and where the importer is the user, the user himself. This is a default position, as this person may not have been appointed by the manufacturer to do this, but nevertheless the role is his. If the manufacturer has not told the importer that he has no Authorised Representative in the EU and there is a legal problem with the product then the user may have recourse in law to seek damages from the manufacturer. The manufacturer should not simply ship the product to the EU and forget about the appointment of the Authorised Representative.

    7. As has been pointed out above, it is not mandatory for the manufacturer to appoint an Authorised Representative and indeed he may not wish to do so. However, it will seem obvious that it is to the manufacturers advantage to have a formally appointed Authorised Representative in the EU to fulfil this role. This is particularly the case where the manufacturer is located outside the EU and is supplying a product to only one end user in the EU. Someone becomes the de facto responsible person if an Authorised Representative is not formally appointed. This is the first person causing the product to be imported into the EU. He takes on the responsibility for issuing the manufacturers DoC and holding the technical documentation that supports the claim for conformity (in the case of the TCF route being used, or EMC Type Examination having been performed). This may be an importing agent, acting on behalf of the user, or the user himself (when he is importing something for his own use). The DoC, under these circumstances, may be prepared by the manufacturer, wherever he is located, but it is formally issued in the EU by the Authorised Representative (when legally appointed), the importing agent, or the user. It, and the documentation confirming conformity of the product, must be retained in the EU for ten years after the last product has been imported and taken into service. The appointment of the Authorised Representative is confirmed in the European Commissions guidelines for the EMC directive where it states that the Authorised Representative must be located in the EU.

    8. The procedures are the same for the TCF route, but differ where EC Type Examination is performed. In the latter case the Notified Bodies in the EU require that the application for EC Type Examination be made by the Authorised Representative of the non-EU manufacturer. This means that unless the importer or end user agrees to be formally bound by this requirement, and be duly appointed, the manufacturer must appoint an Authorised Representative of his own. However, with the introduction of the Radio and Telecommunication Terminal Equipment Directive there is a much reduced requirement for EC Type Examination for radio equipment.

    9. The LVD is similar to the EMC Directive although the CE marking requirements are specifically detailed in Annex III and Annex IV of the amended directive. The technical documentation supporting the claim for conformity is also required to be held for a period of ten years after the last product was produced and imported and it is specifically stated that it be held in the EU (Annex IV).

    10. Where product is supplied directly to the end user or is imported via an importing agent it is the person importing the product whom holds the DoC. In the absence of there being an importing agent the DoC is held by the user. Issuing the DoC and making available of the technical documentation remains the responsibility of the manufacturer or his Authorised Representative established in the EU. When appointed the Authorised Representative is responsible for holding the technical documentation in the EU.

    11. When the product is supplied directly to the end user and that person holds only the DoC he may be requested to provide additional information as to the conformity of the product. In this case he should be able, with the assistance of the manufacturer, to assemble the technical documentation detailed in Annex IV. Some competent authorities in the EU view this as also meaning the technical documentation must always be held as an assembled document, whilst others view it as meaning that the documentation must be able to be assembled, but only when requested. The user or importing agent is not authorised to issue the DoC. When issued, however, the user may be asked to supply a copy. This will only be to either an enforcement agent or competent authority that may query the conformity of the product being used.

    12. Electrical safety is viewed as being of extreme importance in the EU. There are far more court cases for infringement of electrical safety than for all other legal charges for product non-conformity. It is therefore extremely important that manufacturers get their documentation correct. Failure to do so can be extremely expensive in terms of legal fees and lost sales.

    13. The Machinery Directive, also commonly known as the Machinery 'Safety' Directive or MSD, again varies slightly from the other two directives. Because of the specific design nature of many machines the MSD permits the manufacturer to be the responsible person, even though the manufacturer may be located outside the EU. This is because the nature of machines and the certification requirements for safety are such that many are only finally constructed and certified after installation by the end user. Therefore if the manufacturer is responsible for holding the documentation then the user or installer must accept responsibility for making the equipment safe. This includes ensuring the correct installation and use of the machinery to comply with the conformity requirements and the responsibility for assembling the technical file describing the safety of the product, where the competent authority requests that this be done, and holding the DoC.

    14. If the manufacturer, located outside the EU, wishes to appoint an Authorised Representative in the EU he may do so and the provisions and services of this person are the same as for the other directives. Where he is does not do so and uses the services of the importer or user for assembling the technical file, it is the responsibility of that person to ensure that the equipment is in conformity. If it does not initially comply, then it is the importer or users responsibility to bring it into conformity.

    15. As stated above, it is the responsibility of the manufacturer or his Authorised Representative to issue the DoC and affix the CE marking. Therefore it is considered that the Authorised Representative should have a detailed knowledge as to the conformity of the equipment before it is taken into service. This equally applies where the user is responsible for assembling the technical documentation and bringing the machinery into conformity, (when the manufacturer is the responsible person and is located outside the EU).

    16. The MSD is also different from other directives in that a DoC must be issued with each machine. If the manufacture has applied this directive for a series production of machines each machine must be accompanied by a DoC that covers that specific machine. The DoCs generally have the serial number of the machine on them (where serial numbers are available).

    17. The Medical Device Directive (MDD) specifically requires that the manufacturer, or his Authorised Representative established in the Community, make the technical documentation required available to the national authorities in the EU. Where neither the manufacturer nor his Authorised Representative is established in the Community this obligation to keep the technical documentation available must fall to the person who places the product on the Community market. Again these provisions mirror the requirements of other directives. However, the MDD differs from other directives in the product classification requirements and the procedures that accompany the certification for different product classes.

    18. The MDD classifies products into Class I, Class IIa, Class IIb and Class III. The lowest risk products are Class I, and the highest risk Class III. The choice of class is dependent on the end use of the product and hence the risk to either the person using it or the patient. All products in Classes IIa, IIb and III must come under the supervision and certification by an EU Notified Body. The Notified Body has specific responsibilities for surveillance of quality systems associated with the products manufacture. This is only applicable to Class I products where the product is sterilised. In this case the Notified Bodys examination is limited to those aspects of the manufacture of the product that are concerned with securing and maintaining sterile conditions.

    19. For all classes of product the manufacturer must prepare a technical dossier or file for the product providing details of the information on the product, as required by the provisions of the Annexes in the MDD, being applied. Where Notified Body approval is required this information is lodged with the application for assessment of the quality system with the notified body. The Notified Body will then examine the system and all the documentation supplied and after agreement will issue the appropriate reports or certificates. For Class III products the manufacturer must have a full quality assurance system or apply for EC type examination and apply the procedures of a lesser quality system. For class IIa and IIb the requirements are less onerous.

    20. Essentially the manufacturer is responsible for meeting the requirements of the Notified Body with respect to both the product performance, and the quality procedures being used. EC type examination procedures, as well as the other routes available for other classes of product, require that a design dossier be kept in the EU by the manufacturer. This is by his Authorised Representative, the person responsible for placing the device on the Community market, or the importer. Experience leads one to the conclusion that all Notified Bodies require either the manufacturer to be located in the EU or for him formally to appoint an Authorised Representative. Reliance on the person responsible for placing the product on the community market or the importer does not seem to be acceptable.

    21. The provisions of Annex VII of the MDD are applied to Class I products. This is the EC Declaration of Conformity route. It may also be applied in conjunction with the quality assurance surveillance procedures in Annexes IV, V and VI. These cover EC type Examination, production quality assurance and product quality assurance.

    22. The provision of Annex VII require that the manufacturer or his Authorised Representative established in the Community must make available to the national authorities, for inspection purposes, the technical documentation required by Section 3 of Annex VII. This documentation must be retained for at least 5 years after the last product has been manufactured. This obligation falls to the person who places the product on the Community market, should the manufacturer (located outside the Community) not appoint an Authorised Representative. This latter approach is difficult in the case of manufacturers with a number of sales representatives in the EU. In addition Article 14 of the MDD requires that, where the manufacturer does not have a registered place of business in a Member State he shall designate the person(s) responsible for marketing them who is (are) established in the Community. These person shall inform the competent authorities of the Member State in which they have their registered place of business of the registered place of business and the category of devices. This is generally performed by the Authorised Representative in the EU, on behalf of all organisations selling the products. However some competent authorities also want sales organisations in their countries to register products as well. This is not demanded by all Member States.

    23. As the requirements of Annex I, Section 13.3 require that the label on the product includes, for devices imported into the Community, the name of the person marketing the product (as in Article 14) or the Authorised Representative, or the importer. In the event that there are more names under Article 14 provisions or more than one importer then it is usual to include the name of the Authorised Representative.

    24. Having completed all the certification requirements and met the needs of the registration procedures, for Class I products, manufacturers must ensure that their vigilance schemes are maintained. It is an essential requirement for the maintenance of the CE marking that all manufacturers of medical devices has a post-production surveillance and corrective actions system in place that ensures any malfunctions or deterioration in characteristics associated with the product are recognised and reported to the competent authorities.

    25. The R&TTE Directive is a relatively new directive and it replaces the existing Telecommunications Terminal Equipment Directive, 98/13/EEC, which superseded the Satellite Earth Station Equipment Directive, 93/97/EEC, and the old Telecommunications Terminal Equipment Directive, 91/263/EEC. The R&TTE Directive has now been transposed into UK law by Statutory Instrument 2000, No. 730. It was created by the commission to facilitate free trade and free movement of goods and to speed up the emergence of new technologies throughout the European Union (EU). Its main objective is to harmonize the radio and telecommunications industry, simplify the conformity process, and reduce time for the introduction of new equipment. The R&TTE Directive ended its 1-year transitional period, on 7th April 2001. All R&TTE products now being produced must comply with the provisions of the R&TTED.

    26. The certification provisions of the R&TTED are such that manufacturers must apply the requirements of the EMC Directive and Low Voltage directive. These rules are applied differently, as follows:
    For both Radio equipment and TTE:

    the protection of the health and safety of the user and any other persons, including the objectives with respect to safety requirements contained in Directive 73/23/EEC (the LVD), but with no voltage limits applying; and

    the protection requirements with respect to electromagnetic compatibility contained in Directive 89/336/EEC (the EMC Directive).
    For Radio equipment only:

    radio equipment shall be so constructed that it effectively uses the spectrum allocated to terrestrial/space radio communications and orbital resources so as to avoid harmful interference.

    Additional requirements, which may be applied to equipment if the Commission make a decision to apply them to certain types of equipment. For these refer to the R&TTED itself.

    27. As with the other directives detailed in this document, it is the responsibility of the manufacturer or his authorised representative to ensure that the CE marking is correctly affixed. In the case of this directive, the name of the responsible person must be identified on the apparatus. Where it is not possible to do this, because of the size of the apparatus, the name must be made available on the accompanying documentation.

    28. The R&TTED is a directive that really has been designed to simplify the certification of products, but in doing so a lot of new requirements are placed on manufacturers. It is the first directive of this type in the EU and there is considerable concern that it will not be adequately applied. Therefore a committee has been established to oversee its application. If it prove to be inadequately applied there may be pressure on the EU Commission to rescind its provisions and return to a more controlled form of directive. Therefore, the benefits of the directive should not be wasted by not complying with its provisions, particularly those concerning product certification and marking.

    29. Where a number of directives apply to a product the provisions of each directive must be applied. DoCs may be issued for each directive or a single DoC may be issued to cover all directives applied. The rules governing the appointment of the Authorised Representative must also be obeyed. Therefore where a person has been appointed as an Authorised Representative for a specific directive there is an assumption that that person will cover all other applicable directives as well. The actual arrangements are dependent on the contract between the manufacturer and the Authorised Representative.

    30. Where the manufacturer, outside the EU, sells to a specific customer in the EU and does not appoint an Authorised Representative the importer or user of the product must accept responsibility for holding all the appropriate documentation covering all the applicable directives. For the MSD this may also include affixing the CE marking and bringing the machinery into conformity.

    31. Should third party assessment be required then some authorities insist on the appointment of an Authorised Representative as a prerequisite for certification. This is the case in UK for the EMC Directive and the MDD, where a DoC issued in the UK must state the name of the Authorised Representative or the responsible person. Where there is no formally appointed Authorised Representative, the end user or importer is to be responsible for holding the DoCs. If there is no formally appointed Authorised Representative then the importer, user, or person placing the product on the market, should be informed that this is the case. He should be informed that he is to be the de facto responsible person, is responsible for issuing the DoC and, where used, the third party assessment body should be informed accordingly.

    32. The retention of documentation, for a period of ten years (five years for the MDD) after the last product was produced is a requirement of all directives. Manufacturers must therefore accept that, subject to them still being in business, that they should appoint an Authorised Representative for at least this period. Should they wish to appoint an alternative Authorised Representative during the ten year period instead this is acceptable, but the DoCs will have to be reissued and possibly all customers previously supplied informed. Should they wish to cease having an Authorised Representative then some legal responsibilities for their products devolve to the importer or the first person placing that product on the market (or taking it into service) in the EU. That person should be informed of this fact as he is automatically accepting a legal responsibility which may not have been part of the original contractual arrangements with the manufacturer.
    33. This is not a CE marking requirement. National type approval bodies in the EU require that a formal application be made for approval of all transmitters. In many cases licenses to operate these are then required. Application must be made nationally, as there is no cross EU agreement on this. This is being worked on and some provisions are coming into place. Practically, all national bodies require that the application be made by a person authorised on behalf of the manufacturer, who may then be held liable if the equipment fails to meet the accepted standards. This is the manufacturers Authorised Representative in the EU. This person may be the same as the person who fulfils the role for the CE marking directives.


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