CE-Marked Product List (MDD)

Transcription

1 CE-Marked Product List (MDD) On March 21st the revised Directive 93/42/EEC concerning medical devices which includes the amendment M5 Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 has been enforced. With the enforcement of the amended directive obligations of the legal manufacture placing CE marked product on the market and obligations of the Notified Bodies have been affected. Notified Bodies are now required to implement a sampling assessment of technical documentation as specified in Annex II 7.2 to 7.5, Annex V 6.2 to 6.4, and Annex VI 6.2 to 6.4. In order to implement the new sampling assessment of the manufacturer s technical documentation in an efficient and effective way, TUV Rheinland requires its customer to submit information regarding CE Marked products placed on the market on a regular basis. This one of the responsibility the certified customer (e.g. legal manufacturer) has in order to maintain its certification valid. At the initial application stage, all customers must submit a list of medical devices to be covered by the scope of certification as indicate in the initial application forms. Once certified, the customer is able to mark its products covered by the MDD certificate with the CE Marking before placing the product on the EU market. The certified client is also entitled to CE Marked additional products fitting under the General Product Group Name covered by the certification scope as indicated on the MDD certificate. The certified customer shall make available the information to TUV Rheinland on a regular basis or upon request. To submit the required information the manufacturer has the option to use its own internal tools to control the required information as outlined in this document. However, TUV Rheinland requires that the submitted information shall be consistent with the requirements outlined in this document. We would like to thank you very much for you understanding and cooperation in this very important matter. Instruction on How to Compile the Data Required in the CE Marked Product List The CE Marked Product List (MDD) shall be a controlled document included in the quality management system of the MDD legal manufacturer. The legal manufacture is responsible to ensure that all products are listed in the CE Marked Product List (MDD) before they are placed onto the market with the CE0197 identification. The legal manufacturer is responsible to update the list whenever a new product is place on the market with the CE0197 identification. Only products that are covered by the certification scope of the Notified Body TUV Rheinland LGA Products GmbH certificate can be listed on this list. In case of thought, please confirm with TUV Rheinland if the additional products planned for the listing are covered by the Notified Body TUV Rheinland LGA Products GmbH certificate. As a controlled document, the CE Marked Product List (MDD) shall be approved by a responsible person and have document No., issue date, and revision number. Fig.1 gives an example of the information to be submitted to TUV Rheinland. Instructions CE Marked Product List.doc Rev. 0, Page 1 of 5

2 Outline of the Data Fields in Fig.1 The following instruction provides an explanation of the data fields content in the attached Fig. 1. The customer has the option to change the order of the layout as deemed convenient, as long as all the information listed below is provide accordingly. Please use one line for each product in table of Fig.1. (If a product with the same name is classified into two different classes, please also use one line per product.) (a). Field Product Name : The field product name has two fields called Model or Type and Name. Please enter Model or Type of your product as indicated on the rating label of your product. This is typically composed of a number of numeric and alphabetic characters. Whilst Name is typically the designation on the rating label used to identify the brand name(s) for product. (If different brand names exist for one individual product, all brand names need to be listed.) (b). Field General Product Group Name : Please enter a product group name as it appears in product related standards (e.g. defibrillator, hip implant, MRI, electro gradiograph (ECG), surgical needles, surgical sutures, etc.). This General Product Group Name should match the product category as listed on the valid MDD certificate. (c). Field MDD Classification Rule : The classification rule is provided in the Annex IX of the MDD. Please classify your product accordingly, and indicate in this field the Rule that was applied to classify your product (e.g. Rule 1, Rule 9, etc.) (d). Field MDD Classification : Please enter the classification result for the product as indicated in the MDD Classification Rule. The following terms shall be used to identify the MDD classes: (a). Im - for class I medical devises with sterilization (b). Is - for class I medical devises with measuring function (c). Others: IIa, IIb, III (e). Field Allocation of all Products into Device Subcategories According to NBOG BPG : Please allocate your product to the best fitting device subcategories as indicated in the attached TUV Rheinland Device Subcategory in Table 1. These subcategories are base on the NBOG BPG document. (f). Field GMDN # (number) for Class llb Products. This field is reserved for the GMDN # which is required for all class IIb products. To obtain the number of the so called Preferred Terms or P-Terms for Product Identification, please access the homepage of the GMDN Agency ( and follow the given instructions. Example: P16966 (Note: European Commission adopted the decision to make the use of the Eudamed database obligatory by EU Member States from 1 May 2011) (g). Field Allocation of Class IIb Products into Generic Device Groups Instructions CE Marked Product List.doc Rev. 0, Page 2 of 5

3 When obtaining the GMDN number you will gain access to the Generic Device Group. Please record for Product Identification the description of the relevant P-Term in this field. Example: Synthetic Bone Graft (h). Field TD/DD Identifier Please add the name and/or revision date and/or revision number of the Technical Documentation (TD) or Design Dossier (DD) into the field. The content of this field should enable the audit team to identify the overall technical documentation for the product held by the legal manufacturers. (i). Field Sterilization Method : If applicable, in this field please indicate the sterilization method used on the product. (e.g. Sterilization by ETO, Irradiation (Gamma/ Electron Beam), Moist Heat, Peroxide, Liquid Chemical Sterilants) (j). Field Sterilization Facility Please indicate the all location(s) (including outsourced) where the sterilization of the product has been performed. The address of the location(s) does not need to be included in this field. However, a clear identifier needs to be used in such a way that the identifier enables the audit team to trace the name and address of the facility in a different document held by the legal manufacturer. This document shall be available to the audit team. (k). Field R&D Facility Please indicate the all location(s) (including outsourced) where the product has been designed. The address of the location(s) does not need to be included in this field. However, a clear identifier needs to be used in such a way that the identifier enables the audit team to trace the name and address of the facility in a different document held by the legal manufacturer. This document shall be available to the audit team. (l). Field Manufacturing Facility Please indicate the all location(s) (including outsourced) where the product has been manufactured. The address of the location(s) does not need to be included in this field. However, a clear identifier needs to be used in such a way that the identifier enables the audit team to trace the name and address of the facility in a different document held by the legal manufacturer. This document shall be available to the audit team. (m). Field Declaration of Conformity The Declaration of Conformity entry has two fields called Initial Issue Date and Latest Revision. In the first field please indicate the issue date of the first declaration of conformity for the product. In the second field, indicate the latest revision date of the declaration of conformity if different from the first issue date. (n). Field EU Representative This field shall indicate European Representative (EU-Rep) for the product. The address of the European Representative does not need to be included in this field. However, a clear identifier needs to be used in such a way that the identifier enables the audit team to trace the name and address of the facility in a different document held by the legal manufacturer. This document shall be available to the audit team. Instructions CE Marked Product List.doc Rev. 0, Page 3 of 5

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5 Table 1. TUV Rheinland Device Subcategory CODE MD 0100 MD 0101 MD 0102 MD 0103 MD 0104 MD 0105 MD 0106 MD 0107 MD 0108 MD 0109 MD 0200 MD 0201 MD 0202 MD 0203 MD 0204 MD 0300 MD 0301 MD 0302 MD 0303 MD 0400 MD 0401 MD 0402 MD 0403 Medical devices, non-active, 93/42/EEC MD SCOPE EXPRESSIONS, NON-ACTIVE MEDICAL DEVICES General non-active, non-implantable medical devices Non-active devices for anaesthesia, emergency and intensive care Non-active devices for injection, infusion, transfusion and dialysis Non-active orthopaedic and rehabilitation devices Non-active medical devices with measuring function Non-active ophthalmologic devices Non-active instruments Contraceptive medical devices Non-active medical devices for disinfecting, cleaning, rinsing Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Non-active implants Non-active cardiovascular implants Non-active orthopaedic implants Non-active functional implants Non-active soft tissue implants Devices for wound care Bandages and wound dressings Suture material and clamps Other medical devices for wound care Non-active dental devices and accessories Non-active dental equipment and instruments Dental materials Dental implants CODE MD 1100 MD 1101 MD 1102 MD 1103 MD 1104 MD 1105 MD 1106 MD 1107 MD 1108 MD 1109 MD 1110 MD 1111 MD 1200 MD 1201 MD 1202 MD 1300 MD 1301 MD 1302 MD 1400 MD 1401 MD 1402 MD 1403 MD 1404 Medical devices, active, 93/42/EEC MD SCOPE EXPRESSIONS, ACTIVE (NON-IMPLANTABLE) MEDICAL DEVICES General active medical devices Devices for extra-corporal circulation, infusion and haemopheresis Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia Devices for stimulation or inhibition Active surgical devices Active ophthalmologic devices Active dental devices Active devices for disinfection and sterilisation Active rehabilitation devices and active prostheses Active devices for patient positioning and transport Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Software Devices for imaging Imaging devices utilising ionizing radiation Imaging devices utilising non-ionizing radiation Monitoring devices Monitoring devices of non-vital physiological parameters Monitoring devices of vital physiological parameters Devices for radiation therapy and thermo therapy Devices utilising ionizing radiation Devices utilising non-ionizing radiation Devices for hyperthermia / hypothermia Devices for (extracorporal) shock-wave therapy (lithotripsy) Instructions CE Marked Product List.doc Rev. 0, Page 5 of 5