Whether you are looking for assistance in choosing a suitable notified body or you want to make sure you are fully prepared for an upcoming audit, give our consultants a call. At Patient Guard Ltd, in Blackpool, Lancashire, we specialise in all aspects of medical device development. Our team are highly experienced in working with notified bodies, and we will be happy to help you determine which one is best for you. Equally, we are experts in completing test audits of your technical file to ensure you are prepared for a real ISO 13485 audit.
With the recent implementation of the new regulations, notified bodies (NBs) will be audited much more robustly by the national competent authorities, who are already required to perform unannounced visits at least every 3 years on manufacturers or persons with legal responsibility for the device being on the market. The regulations will make it harder for a manufacturer to change notified body as easily as was allowed previously, should they be dissatisfied with the findings of the NB.
With this development, it becomes even more important that you select a good NB that is going to be suitable for your business needs. Patient Guard Ltd has experience of working with a number of NBs. Our consultants will be happy to explain the pros and cons of each NB and help you decide which one best suits your business.
If you are ISO 13485 and/or ISO 9001 certified, your quality management system (QMS) will have likely been certified by a NB. If your device is classified as I (Sterile/Measuring), IIa, IIb, or III, then a NB is required to certify the device. They will do this by performing an annual audit of your [technical file] in accordance with the relevant conformity assessment in the Medical Device Directives and issuing a CE certificate to say that your device conforms. The CE certificate allows you to place a CE mark, followed by the NB's number, on your device and trade within the EU.
If your device is a Class I device that does not require sterilisation or has a measuring function, then you can perform a self-certification of the CE mark. However, you are required to register with a EU [competent authority] like the MHRA in the UK. Once you have registered and completed the self-certification, you are free to place the CE mark on your device. Please note that, unlike NB certifications, no number is required after this CE mark.
Patient Guard Ltd is vastly experienced with NB audits and understands that they can make you feel pressurised. If your technical file and QMS are up to date and compliant, there is little to worry about from a NB audit. To ensure you feel ready for a scheduled or unannounced NB audit, we can perform practice audits on your technical files and QMS. If you are interested in booking a practice audit, please give our consultants a call.