Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Our expert consultants throughout Europe have experience classifying a range of medical technologies, including novel and innovative devices. There still the distinction between a Body Orifice and an orifice made through the surface of the body. One last action for you. What is interesting on this MEDDEV is that it provides a lot of examples of products per class. Sorry for making it more complicated, but when your Notified Body has it’s place of business in a different member state than the manufacturer, then it’s more difficult. The new Medical Device Regulation is completely changing the way we look at software. means normally intended for continuous use for less than 60 minutes. New sub-class for products that are reprocessed. Let me provide you with some medical device classification examples in Europe for each class: To classify your product, you have the hard way: I created a free form that will really help you to classify your product and also to archive your data electronically. And the MDR regulation 2017/745 created Article 51 for this case. And don’t forget to write a comment even if it is just to say that you liked the exercise. View All. Look at each rule from first to last. Most devices fall under the Medical Devices Directive (MDD) 93/42/EEC, but some high-risk implantable products must follow the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. The new Regulations contain important improvements including a much larger EUDAMED database than the one that currently exists under the Medical Devices Directives ( … So keep in contact with your Notified Body. I suppose that most of those example will remain true for the MDR, so in case you are struggling to find the class of your product, you can try to have a look to this guide. My objective is to share my knowledge and experience with the community of people working in the Medical Device field. Medical Device Classification in the EU MDR. Essentially, all devices fall into four basic categories: The MDR has a few additional special rules, including one for nanomaterials. Note the MDR also includes products specifically delineated in Annex XVI that do not have a medical purpose. While classification is primarily the concern of the manufacturer, if the device falls into Classes IIa, IIb … We have deep expertise with a range of product types, including combination and borderline products. So, if you have no other choice, use this article (I cannot promise any timing for results). The EU MDR 2017/745 has 4 main categories for Medical Devices classification: This goes from the products with low risk (Class I) to the products with high risk (Class III). Advisory Committee/Panel Meetings - CDRH. By the way, I created a Mini-Course to teach you everything about the new Medical Device Regulation EU MDR 2017/745, and this is free. This document is a guide for classifying medical devices covered by the European Directive 93/42/EEC (‘the Directive’), as amended and the related Irish regulation, S.I. These are the audits that Medical Device manufacturers should be ready for. 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