Russell Square Quality Representatives (RSQR)
Please note that effective 25th November 2008 our mailing address changed
LUDGATE HOUSE, 107-111 FLEET STREET, LONDON EC4A 2AB
Russell Square Quality Representatives (RSQR) was set up in June 1997 to provide authorised representative services under the Medical Devices Directive 93/42/EEC for medical device manufacturers outside the European Economic Area (EEA), and who have no other presence within the EEA, but who nevertheless wish to market their (appropriately CE-marked) medical devices throughout Europe.
With the publication of the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC, RSQR further extended its range of activities to include Authorised Representative clients under this Directive also.
The engagement of an Authorised Representative is an important step in medical devices manufacturers' marketing strategy, and should not be made lightly: RSQR personnel have experience in European Regulatory Affairs acquired as former employees of the (then) Medical Devices Agency, now called the Medicinal and Healthcare products Regulatory Agency (MHRA) - the UK medical devices Competent Authority; we continually update our expertise in this area so as to provide our clients with the best service possible.
Why you should use a dedicated Authorised Representative - not a distributor
Many manufacturers nominate a distributor within the EEA as their Authorised Representative. For several reasons this may not be the best course of action, even though a distributor may be persuaded to offer the service "for free":
- firstly, distributors are not generally expected to posess the regulatory expertise required of an AR, and very few do;
- secondly since few distributors act for one manufacturer alone, there is a clear conflict of interest, given that the AR is expected to hold detailed technical information on the products in view, and to behave neutrally in all actions and responsibilities;
- thirdly, a distributor AR may be required to make decisions that are contrary to sales objectives - another source of potential conflict;
- fourth, should the manufacturer wish to change distributor, the original distributor AR's name will still appear on labelling for some time after new arrangements have been concluded, and may be a source of embarrassment;
- finally, manufacturers need to be sure that if an incident does occur and the AR is addressed by the Competent Authority, then the AR's response will be accurate and timely.
Russell Square Quality Representatives Ltd only provides AR services. Through its sister company Russell Square Quality Associates Ltd it also applies to AR clients the expertise necessary to assess and advise on Technical File content, Vigilance Procedures, the format of the Declaration of Conformity, Essential Requirement Checklists, Risk Assessment, labelling - and much more.
In addition, also through RSQA Ltd., we offer full consultancy services and on-site assessment as required by our clients.
The AR must be explicitly designated by the manufacturer, and acts and may be addressed by Competent Authorities and Notified bodies within the EEA instead of the manufacturer with reference to the latter's obligations under the applicable Directive.
Under the terms of the IVD Directive, and also for Class I devices under the MDD, the AR is obliged to notify the Competent Authority of the member state in which he has his place of business of:
- the address of registered place of business of the manufacturer and the AR;
- (for the IVDD):
- information relating to reagents, reagent products, and calibration and control materials in terms of the common technical characteristics and / or analytes and of any significant change thereto including discontuation of placing on the market; for other devices the appropriate indications;
- in the case of devices covered by Annex II, and of devices for self-testing, of all data allowing for identification of such devices, the analytical and, where appropriate diagnostic parameters as referred to in Annex I, part A section 3 (of the IVDD), the outcome of performance evaluations pursuant to Annex VIII, Certificates and any significant changes thereto, including discontinuation of placing on the market;
- for Annex II devices for self-testing, ARs may have to provide the Competent Authority with identification data, labels and Instructions for Use when devices are placed on the market within particular CA's territory (Article 10, para. 1-3).
Some Legal Aspects
- The AR must be designated in writing, and the relationship between the AR and manufacturer defined in contract.
- The AR has a responsibility to the European Commission, and represents the manufacturer in all European Regulatory Affairs matters.
- The name and address of the AR must be included in product labelling and/or Instructions for Use. (RSQR's name and address for application to labels, etc. has a specific form provided to clients on conclusion of contractual arrangements).
- The AR has an obligation to submit medical device incident reports on behalf of the manufacturer to relevant Competent Authorities. There are defined time-frames for this activity, and failure to meet them can have serious consequences both for AR and manufacturer alike.
- It is possible that the AR could face liability claims in the event of product defect or serious complaint / adverse incident.
- The identity of and contract with the AR should be included within manufacturer's Quality Management System documentation.
Summary of Authorised Representative Services
- Should a reportable adverse incident occur with the device(s) for which the Authorised Representative (AR) is nominated, the AR would be the first point of contact for the Competent Authority (CA) under whose area the incident occurred. (MDD Article 10, para. 2), (IVDD Article 11, para. 2).
- The AR would handle communications between the manufacturer and the CA where it was required to report to the CA adverse incident occurring elsewhere which might impact upon the use of the device within the EEA.
- The AR may engage, negotiate with and provide a communications channel to a Notified Body on the manufacturer's behalf in respect of conformity assessment arrangements, including type testing, and the provision of documentation relevant to these activities. (MDD Article 11 para. 8 & 9, Annex III para.2), (IVDD Article 9, para.6 & 8). The AR may also be involved in setting time limits for these activities. (IVDD Article 16, para. 4).
- The AR may have responsibility for handling complaints and vigilance data arising from the marketing of the device(s) within the EEA. (MDD Article 10 para. 2)
- The AR may be involved in correspondence / negotiations concerning a product's acceptance for open sale within the EEA. (MDD Article 19 para. 2). The AR may be involved in consultations with the CA where the latter had decided to refuse or restrict access of the device to the European Market. (IVDD Article 18).
- Where the manufacturer's CE mark was deemed to be wrongly affixed, the AR would be the first point of contact for regulatory agencies within the EEA. (MDD Article 18a). Where an infringement has occurred, the AR will be obliged to take steps to end such infringement. (IVDD Article 17).
- The AR may make the appropriate EC Declaration of Conformity (MDD Annex VII para.1 & 2) or the Statement Concerning Devices for Special Purposes (MDD Annex VIII para. 1) on the manufacturer's behalf. (IVDD Annex III para. 1, Annex V para.2, Annex VI para.1, Annex VIII para.1).
- The AR may be required to maintain files for published technical data, complaints analysis and risk analysis appropriate to the devices which refer to the AR. (MDD Article 15 para. 1 & 6)
- The AR may require to have available - or at minimum obtainable at short notice - technical documentation that is part of the manufacturer's quality Management System (MDD Annex II para. 6.1), and may be responsible for confirming the results of any verification tests undertaken by the manufacturer. (MDD Annex IV para. 7)
- All AR activities records will be retained for a minimum of five years. (MDD Annex III para 7.4). The AR must keep the Declaration of Conformity, the Technical Documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates established by Notified Bodies, available to national authorities for inspection purposes for a period of 5 years after the last product is manufactured. (IVDD Article 9, para. 7).
- The Authorised Representative's name and address must appear on the device packaging / labelling if no details of the importer, distributor or agent are so printed. (MDD). The label, the outer packaging, or the Instructions for Use shall contain the AR's address. (IVDD Annex I, E.R. 8.4, E.R. 8.7)
The Authorised Representative's duties above would subject to contractual agreement between RSQR and the manufacturer, which terms must include and address all the points above, and must clearly define in each case whether the responsibility is intended to be RSQR's or the manufacturer's.
- 1. Official Journal of the European Communities, L169, Vol. 36, 12 July 1993: * Council Directive 93/42/EEC concerning medical devices.......
- 2. Official Journal of the European Communities, L331, Vol., 7 December 1998: * Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices......
For further information please email us or call us on +44 (0) 207 936 9412.