CE Marked Product List (MDD)
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 CE0197identification. 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.
CE Marked Product List (MDD)
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 2009-3”:
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 2009-03 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 (www.gmdnagency.org) 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)
CE Marked Product List (MDD)
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.
CE Marked Product List (MDD)
Table 1. TUV Rheinland Device Subcategory
Medical devices, non-active, 93/42/EEC
CODE MD SCOPE EXPRESSIONS, NON-ACTIVE MEDICAL DEVICES
MD 0100 General non-active, non-implantable medical devices
MD 0101 Non-active devices for anaesthesia, emergency and intensive care MD 0102 Non-active devices for injection, infusion, transfusion and dialysis MD 0103 Non-active orthopaedic and rehabilitation devices
MD 0104 Non-active medical devices with measuring function MD 0105 Non-active ophthalmologic devices
MD 0106 Non-active instruments MD 0107 Contraceptive medical devices
MD 0108 Non-active medical devices for disinfecting, cleaning, rinsing
MD 0109 Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
MD 0200 Non-active implants
MD 0201 Non-active cardiovascular implants MD 0202 Non-active orthopaedic implants MD 0203 Non-active functional implants MD 0204 Non-active soft tissue implants MD 0300 Devices for wound care MD 0301 Bandages and wound dressings MD 0302 Suture material and clamps
MD 0303 Other medical devices for wound care MD 0400 Non-active dental devices and accessories MD 0401 Non-active dental equipment and instruments MD 0402 Dental materials
MD 0403 Dental implants
Medical devices, active, 93/42/EEC
CODE MD SCOPE EXPRESSIONS, ACTIVE (NON-IMPLANTABLE) MEDICAL DEVICES MD 1100 General active medical devices
MD 1101 Devices for extra-corporal circulation, infusion and haemopheresis
MD 1102 Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
MD 1103 Devices for stimulation or inhibition MD 1104 Active surgical devices
MD 1105 Active ophthalmologic devices MD 1106 Active dental devices
MD 1107 Active devices for disinfection and sterilisation MD 1108 Active rehabilitation devices and active prostheses MD 1109 Active devices for patient positioning and transport
MD 1110 Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
MD 1111 Software
MD 1200 Devices for imaging
MD 1201 Imaging devices utilising ionizing radiation MD 1202 Imaging devices utilising non-ionizing radiation MD 1300 Monitoring devices
MD 1301 Monitoring devices of non-vital physiological parameters MD 1302 Monitoring devices of vital physiological parameters MD 1400 Devices for radiation therapy and thermo therapy MD 1401 Devices utilising ionizing radiation
MD 1402 Devices utilising non-ionizing radiation MD 1403 Devices for hyperthermia / hypothermia
