To obtain medical device CE mark and place a medical device on the market in the EU, manufacturers must now demonstrate conformity with the EU 2017/745 Medical Device Regulation (MDR) which has replaced the previous Medical Device Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). Continue reading about how to place a medical device on a market
Medical device manufacturers must prepare technical documentation otherwise known as product technical file. Once technical documentation, according to Annex II and III, has been prepared for a medical device the manufacturer can then draw-up the EU Declaration of Conformity. This declaration should form part of the application to a notifying body for assessing the device model covered by the conformity assessment in order to place the product on the market in the EU. Below is a summary of how to compile a Declaration of Conformity and affix the CE mark to a medical device.
An EU Declaration of Conformity, referred to in Article 19 and Annex IV, is a mandatory document which is required whether the involvement of a Notified Body is necessary or not. The manufacturer of a medical device must sign and take sole responsibility for declaring conformity to all the technical requirements of the EU 2017/745 Medical Device Regulation. It should also be continuously updated by the manufacturer and be kept for 10 years after the last device put on the market (15 years for implantable devices).
Below is a list of information which should be included as a minimum within the Declaration of Conformity (as detailed in Annex IV), and should then be translated into an official language(s) required by the Member States in which the manufacturer intends the device to be sold into:
• Name, registered trade name or registered trademark (and if applicable, authorised representative) and address of registered place of business
• A statement, stating the manufacturer takes sole responsibility
• Basic UDI-DI (device identifier element as detailed in Part C of Annex VI)
• Product and trade name, product code, catalogue number or other unambiguous reference, allowing identification and traceability – this can include an image
• Risk class of the device
• Relevant legislation with which the product complies, as well as any standards or other means to prove compliance
• Details of the notified body which carried out the conformity assessment procedure (if applicable)
• Supplementary information (if applicable)
• Place and date of issue of the declaration
• Name and signature including function of the person who has signed (as well as indication for, and on behalf of whom)
Article 19 also details that where devices are covered by other Union legislation, in addition to the EU MDR, the manufacturer should elaborate a single EU declaration of conformity in respect to all Union acts applicable and applied to the device.
Before affixing the CE mark onto a medical device, if applicable, the Notified Body must perform a conformity assessment and issue an EC certificate according to Annex IX, Annex X and Annex XI. As part of the assessment the Notified Body will examine and assess the technical documentation for conformity with the EU MDR, as well as any applicable harmonised or common standards referred to by the manufacturer. A review of the clinical evidence submitted, along with the suitability of the data will be assessed, taking into accounts factors such as new indications and innovation. These assessments will be performed by individuals with proven knowledge and experience regarding the technology concerned and its clinical application. Further testing or additional evidence may be required, and the Notified Body may also carry out or arrange appropriate physical or laboratory tests necessary to verify application of relevant standards.
Once all the necessary steps have been completed successfully and certificate issued, the CE mark of conformity (as presented in Annex V) in accordance with Article 20 in order to place the product on the market. The CE mark must be affixed in a visible, legible, and indelible form on the device (or its sterile packaging). Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking should be affixed to the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging and where applicable, be followed by the identification number of the relevant Notified Body.
Where devices are subject to other Union legislation, other additional marks may be affixed to the device, packaging, or instructions, however, must not impair the requirements of the CE mark or mislead third parties with regards to the meaning of the marking. A medical device with an affixed CE marking, indicates conformity of the product with the EU MDR, allowing free movement within the Union, enabling the manufacturer to place it on the market in accordance with their intended purpose. However, Member States are still allowed to decide whether to restrict the use of any specific type of device in relation to aspects that are not covered by this Regulation.