Page 1 MEDIMARK EUROPE Europe (France): ® News Tel : + 33 476 86 43 22 Fax : + 33 476 17 19 82 E: email@example.com www.medimark-europe.com USA : Tel : (908) 788 4580 Fax : (908) 788 4590 Febr u a r y 200 2 E-mail:LYLEHOWARD@aol.com Special MD&M West 2002 Issue Conference & Exposition IVD’s and MD’s : Recall : What shall you do when implementing a recall in Europe ? Comments by MediMark® Europe, the most experienced and ISO Certified European Authorized Representative . . .The last guidelines on a Medical Device Vigilance informed the users by phone, but not by fax or mail.System (MEDDEV 2.12-1 rev 4) issued in April 2001 The MDA (UK C.A.) considered that it was thetake into account work produced by the Study Group 2 responsibility of the Manufacturer (i.e. its Europeanof the Global Harmonization Task Force (GHTF) and Authorized Representative) to take the necessary measuressome adaptation for the IVD’s but still do not develop for being sure that the recall is correctly implemented inenough guidance for the implementation of recall. the field.So your current recall procedure may not be adapted for So, it is very important that your recall procedure includesanswering the increasing demand of follow up from directives to be given to your distributors, and also addsthe European Competent Authorities. For example, clauses in the distributor’s contract concerning thehow are you going to answer when a Competent vigilance system (recall, incident reporting, etc . . .)Authority asks you for the written proof that your As usual, MediMark® Europe, representing non-Europeandistributors have effectively informed the users to cease Manufacturers before the E.E.A Competent Authorities,immediately the use of the recalled devices ? strives to give you in its newsletter practical informationThis case occurred recently in UK. The distributor had which helps you to review your systems.M EDIM ARK E UROPE, ®is recognized today as the European Authorized Representative giving professional services to itscurrent customers and answering thoroughly to therequest of European Competent Authorities. Should Contentsyou need more details, do not hesitate to call, to fax 2 Recall Procedureor to meet Lynette HOWARD, Philippe LEGLISE orRené CLEMENT at the : 3 Recall ProcedureMD&M WEST 2002 exhibition in Anaheim,February 5-7, 2002. Booth number 1185 4 The Global Harmonization Task ForceMMENEW 02/2002
Page 2 M EDIM ARK E UROPE Ne w s ® Fe b r u a r y 200 2 Practical Advice for a successful European implementation of a recallMost of the recalls are voluntary, occurring after incident reporting by the users, complaint from a distributor, ornon compliance found by the manufacturer itself. This is the corrective action determined by the RA/QAmanagement after a specific risk analysis of the case. One of the most frequent reasons for voluntary recall ismislabeling. Taking into account the risk of medical consequences for patients and the associated cost of arecall, we may only encourage Manufacturers to put all the necessary resources in terms of employee training andquality controls for the labeling operations.However, the zero risk does not exist and when it happens, it is important to respect some rules for an effectiveimplementation of the recall which is more and more controlled by the European Competent AuthoritiesA. Content of the Advisory notice to Distributors: B. Notification to Competent Authorities :The Manufacturer should issue an advisory notice The last European Vigilance guidelines says in itswhen implementing a recall. The non-European article 5.8.2 :Manufacturer does not know generally the European “ Copies of Advisory Notice should be sent to theusers, so he has to build up an advisory notice to the Competent Authorities of the countries to which theyattention of its distributors. are applicable, and for devices in Class II or Class IIIIt shall contain: or IVDs listed in Annex II or for self-testing, the - Distributor Address, contact name, Tel, Fax, Competent authority in the State where the Notified e-mail Body is situated and which made the attestation which - The nature of the reason for recall and the led to the CE marking attached to the device, and for number of concerned units shipped to him devices in Class I or IVDs neither listed in Annex II with details by shipment date, catalog and lot not for self-testing, the Competent Authority in the numbers state where the manufacturer’s registered place of - The action description that the distributor has business under Article 14 is situated. Manufacturers to take towards users such as : should consider sending copies of advisory notices to“Please discontinue distribution of this recalled product the Competent Authorities under a cover report whichimmediately and contact also immediately by phone, and takes the same structure as a Final report (NDA:fax and official letter the hospitals and other facilities Incident Reporting Final report).which have been delivered, in order to request them todiscontinue use of this product. Notification to Competent Authorities should be madeThis information to the user must be secured through a before or a the same time as recall action is initiated ”formal acknowledgment of receipt issued by the personsinformed by you. In case of difficulty for obtaining such Your European Authorized representative isan acknowledgment of receipt, you must record the date, responsible for these notifications. So it is essentialthe hospital and the names of the persons to whom the that the Manufacturer sends him first all theinformation was delivered.” information about the recall so that he notifies the - The product return information/exchange concerned Competent Authorities before or the same information such as: day that the Advisory Notice is sent to the distributors.“Send all recalled products that you have in stock andproduct collected from your accounts, along with the The Authorized Representative should also propose toenclosed, fully completed Recall Response Sheet (Packing the manufacturer changes in the Advisory NoticeSlip)., to the address above mentioned attention to : content if necessary.Receiving. Freight will be reimbursed and replacement ofproduct will be done at no cost to you.” Some Competent Authorities consider that they have - The Manufacturer’s contact name for to approve the Advisory notice before the Dispatching additional information to distributors. MediMark Europe does not agree with - The European authorized representative’s this position which will delay the recall contact information implementation.
Page 3 M EDIMARK E UROPE Ne w s ® Fe b r u a r y 200 2C. Additional information to send with the This recall response sheet that the user will return toAdvisory Notice: the distributor shall contain at least:Even if the Advisory Notice already includes the 1. Hospital/Institution name, address, phone, fax andrequest to the distributors for the written formalization contact name. The user’s contact name is theof the recall to users, it is important to add explanatory person’s name having ordered the incriminatedannexes. The reason is that a lot of European devices.distribution companies are small, family owned and 2. The caution “ Please complete this form and returntheir structure is more oriented towards selling than within 7 days ”vigilance administration. They are not fully aware of 3. The information about the number of incriminatedthe recent staff development of Competent Authorities devices sent: “According to our records, we haveadding a large numbers of inspectors for the shipped to you the following recalled devices. Pleaseenforcement of the vigilance system. record the quantity returned in the table. Please record a zero for no inventory found ”It means that their follow-up of incident reporting, Catalog Quantity Quantityrecalls and other corrective actions are conducted in a and Lot Number Shipped returnedclose to the chest manner. Failure to conduct correctlyand document the field recall actions may drive to thewithdrawal of the CE Marking for the whole productfamily and in addition penalties such as a fine and jail. 4. The malfunction status: “ Have you received any reports of a malfunction with these devices ?”So, we suggest to put in annex of the Advisory Notice 5. The injury report status: “ Have you received anya notice reinforcing the necessity to formalize the reports of injury to patient or user with these devices?”information to users explaining the probable C.Afollow up such as: 6. The contact name and fax number where the user has to fax this form.“ Dear Distributor, The Competent Authority in yourcountry will probably require the following D. What will request the Competent Authority andinformation in relation to this device recall: to whom:1. Shipment dates The Competent Authorities may contact the2. Quantities shipped distributors very often by phone, but their official3. Name, address and phone number of hospital/user contact for any formal demand is the Manufacturer’s facilities who received the products European Authorized Representative.4. Copies of recall letters sent to hospital/user facilities. (C.A. will require the proof that the As already said, the standard request concerns the recall has been effectively conducted) assurance that the recall has been correctly performed.5. Reconciliation between the quantities sent to Based on this information, they may contact also the hospitals/user facilities and returned to you. by users to check that they have been informed. They them often also ask for details proving that the6. A statement that no incidents occurred with the manufacturing corrective action conducted for avoiding recalled products same reasons of recall have been or will be effectively put in place.We wanted to give advance notice so that you can E. Closing of the recall:maintain the recall documentation accordingly at our The Manufacturer shall edit a final report of the recalldisposal for answering to C.A. request through our including the numbers of units returned and usedEuropean Authorized Representative.” versus shipped and the status of incidents which mayYou may also give to your distributor a model of have been reported by users during the recall. Thisproduct recall response form that he will send in annex report may be asked by the Notified Body and ato the Advisory Notice translation and adaptation for leading Competent Authority as defined by the Globalusers. Harmonization Task Force (GHTF).
Page 4M EDIM ARK E UROPE Ne w s ® Fe b r u a r y 200 2 ‘‘First results of the Global Harmonization Task Force’’The Study Group 2 of the GHTF has published in July Representative for comments before it is expedited.2001 a Final Document concerning the exchange It is only a one page document with small space for theinformation of Incident Reporting between Competent recall information reducing the clarity of the message.Authorities. The result is that several countries not concerned byDuring a recent recall involving only few European this recall send to us a request for additionalCountries, the BfArM (German Competent Authority) explanation.has taken the lead and has communicated the recall The main working and proposed documents of theinformation to all Competent Authorities in the European GHTF are currently: Labeling For Medical Devices,Economic Area and USA, Australia, Canada, Japan, New Information Concerning the Definition of the TermZealand and Switzerland. “Medical Device”, Medical Devices Classification,The form used for the exchange of information between Post Market Surveillance : Universal Manufacturerthese National Competent Authorities is called “ Global Report Format– Medical Devices Vigilance Report ”. You may obtain them by visiting the GHTF Web Site:It is submitted to the Manufacturer’s Authorized www.ghtf.orgMediMark® Europe: The ISO certified • Assistance for the design of your Labels.European Authorized Representative • Review of your Technical Files. • Official registration to Competent AuthoritiesMEDIMARK® EUROPE will be present, as every year, where required (Tax requested by Member Statesat the MD&M West 2002 (Booth 1185) in Anaheim. We are not included).will answer your questions concerning CE Mark for • Responsible before the European CompetentMDs and IVDs and the two options proposed by Authorities of the Incident Reporting, voluntaryMediMark Europe as European Authorized product withdrawal, and negotiation in case of risksRepresentative. of Product Recall (fees included in option 1)..For those who cannot attend the meeting in California, • Maintain an updated copy of the Technical File,the following are the key services provided and included part A, in EU at disposal of Competent Authorities.in the base contract: • Keep the Manufacturer updated with any request• Delivery of a Technical file preparation package. For from Authorities and inform him about changes in example, the package for IVD manufacturer contains: European Regulations. EDMA Nomenclature for notification (Excel) and For more information, do not hesitate to visit our Assessment Flowchart for classification and annexes website www.medimark-europe.com and contact us in to follow (Word), Checklist to ease the building of Europe or for your convenience in USA at: your Technical File documentation (Word), Essential Requirements Checklist (Word), Wide range of IVDs Lynette HOWARD, located in Flemington, New relevant Symbols for multilingual Labeling and other Jersey, Tel : (908) 788 4580 Fax : (908) 788 4590 purposes (Word & bmp), MediMark Europe e-mail: Lylehoward@aol.com _____________________________________________________ bibliography on IVD relevant Standards (Access).• Phone and E-mail hotline for answering your Looking for IVD’s European Distribution Network? questions. Don’t hesitate to contact Mr Alain Ruiz at: ELS Tel: +33 6 11 76 49 24 E-mail: firstname.lastname@example.org _______________________________________________________________________________________________ __ Published by MEDIMARK® EUROPE SARL, Sarl au Capital de 100000 Fr. To find interesting documents concerning Rcs Grenoble B 401812946. APE 748K European Regulatory Affairs! Visit our website ADDRESS :11, rue Emile ZOLA, B.P 2332, www.medimark-europe.com 38033 GRENOBLE CEDEX 2, FRANCE TEL: +33 476 86 43 22 FAX: +33 476 17 19 82 You will see what we can do for you, and Official E-Mail: email@example.com documents, European guidelines, list of Competent www. medimark-europe.com Authorities, last newsletter and several very useful links to obtain updated information about European Regulatory Environment.