According to the new regulation, it is important to understand the EU MDR classification rules – in particular the classification to which your medical device is subject – and the rules for classifications. Looking for more information about the next MDR? Access your free MDR compliance toolkit today. Rules 14 to 22 (including the four new MDR rules) cover special arrangements. These are rules that cannot be classified into the other groups mentioned earlier. The MDR will contain 22 classification rules, four more than the previous Medical Device Directive (MDD). All rules are based on the potential risks associated with the device, its engineering design and how the device is manufactured. The MDR contains 22 classification rules, including four new rules and numerous updates to existing rules. Manufacturers need to review the classification of existing devices under the MDR and may find that some devices need to be “highly classified”, resulting in more stringent regulatory requirements. In particular, Rule 11 requires the attention of any manufacturer possessing a device containing software.
Software that plays a role in decision-making or patient monitoring will be upgraded from a Class I device to a Class IIa device. For more information, see our recent article on software as a medical device. The MDD “Essential Requirements” has been replaced by “General Safety and Performance Requirements” in the MDR. There are 23 requirements, many of which are new, that equipment manufacturers must demonstrate. These regulations place a strong emphasis on risk management and “constitute a set of product characteristics considered essential by European authorities to ensure that any new product is safe throughout its lifetime and performs as intended”. In addition, 42 implementing acts were published to clarify/implement the MDR and 12 broadcasting acts to amend it. In addition, device manufacturers can expect the following systemic changes in the MDR`s approach to clinical assessments: Below are some of the latest publications supporting the implementation of the EU MDR. EUDAMED registration is not yet required and changes to the specific data requirements of the database are expected. Although manufacturers can register their device in the EUDAMED database, it must be maintained for the device after this process. Some companies choose to wait for EUDAMED data requests to be processed.
The MDR was published on April 5, 2017. Medical devices can currently be MDR certified, but not all products need to be MDR certified by May 25, 2024. The new MDR contains a total of 16 ancillary sections, of which Annex XVI is the most sensational. This section requires that certain products be covered by the MDR – those that may not have previously been considered medical devices. As a result, some companies are subject to medical device compliance regulations for the first time. A new application for certification must be submitted by the legal manufacturer, who begins a new certification cycle with a maximum validity of 5 years. Manufacturers must carry out a review of the technical documentation by the notified body and an initial on-site audit activity to verify implementation before certification is issued. The examination of the technical documentation shall be carried out on the basis of random sampling, but this shall not be permitted for class IIb or III implantable devices. Before submitting an application, manufacturers ensure that their technical documentation and design files comply with the MDR. Download the MDR in the main European languages via the link below. The manufacturer`s current quality management system and procedures to ensure relevance and effectiveness. Today, new guidelines are often published that illustrate the legislator`s quest for greater standardization, stricter post-market surveillance requirements, process-oriented risk management and a life-cycle approach to device management.
Medical devices change legislation, find out what you need to know if you are a manufacturer. Rules 1 to 4 apply to non-invasive devices. These devices do not touch the patient or only affect intact skin. We will explain why the old directive needed to be updated, the structure of the new RDM document, and some of the latest requirements that medical device manufacturers need to be aware of. Devices belonging to class III and IIa/b devices must have their UDI registered, indexed and registered in a central EU database called EUDAMED – the European database of medical devices. Manufacturers of these products are responsible for sharing product data in accordance with Part B of Annex VI to the Regulation. How does the EU MDR affect Saint-Gobain? Saint-Gobain is informed of the application and enforcement of the EU MDR from May 2021. Saint-Gobain is not currently a legal manufacturer of a finished medical device, but Saint-Gobain is a supplier to our customers who are the legal manufacturers. Although the requirements of the MDR are not directly applicable to Saint-Gobain, we are aware of the requirements that our customers must comply with and are ready to assist and, where appropriate, provide specific compliance information for components and products supplied by Saint-Gobain. Annex XVI requires the following product groups to comply with MDR requirements: IMNB AB has its registered office in Stockholm, Sweden. We continue to have our teams around the world, including but not limited to North America, China, India, the United Kingdom and Sweden.
Dorothy Wilkerson holds bachelor`s and master`s degrees in biomedical engineering. Dorothy has over 15 years of experience with several medical device companies in the engineering, quality and regulatory fields. Dorothy works closely with Saint-Gobain`s Life Sciences Medical Components sales team to execute business development, business review and other initiatives to execute Saint-Gobain`s medical strategy. As defined in the MDR, manufacturers must establish, document and implement a quality assurance system and maintain its effectiveness throughout the product lifecycle. Emphasis is also placed on management`s role in QMS activities, such as document storage, post-market monitoring and risk assessment of new and existing equipment. MDD certificates are valid until their initial expiry date or until May 26, 2024, whichever comes first. The prerequisite is that compliance with the regulations is maintained, that certain elements of the MDR are respected and that the notified body carries out surveillance activities. For authorised representatives, importers and distributors of medical devices and in vitro diagnostic medical devices.
The MDR defines “medical device” as “instrument, apparatus, device, software, implant, reagent, material or other object” used to: Rules 9 to 13 cover active devices. An active medical device is a medical device that relies on a source of electrical energy or a source of energy other than that produced directly by the human body or by gravity. Our MedTech Lifecycle Excellence (MLE) platform is designed to enable end-to-end product lifecycle excellence from ideation to commercialization and post-market monitoring. And with the upcoming launch of our new regulatory intelligence solution, your product and quality teams can conduct meaningful, up-to-date regulatory investigations more easily than ever before. Liposuction, lipolysis, or lipoplasty devices To keep up, you need a future-proof solution that helps you ensure compliance throughout the product lifecycle. That`s where Greenlight Guru comes in. The new MDR classifications reflect the potential risk of harm posed by a medical device. Class I devices are considered the lowest risk, while Class III devices are considered high-risk devices.
Author: Dorothy Wilkerson – Head of Regulatory Affairs, Saint-Gobain Medical Components FREE RESOURCE: Click here to download your copy of our EU MDR gap analysis tool. Diagnosis, prevention, monitoring, treatment or mitigation of disease, disability or injury, but not for the prevention of disability or injury Regulation (EU) 2017/745 on medical devices replaced the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIDD), while IVDR will replace the In Vitro Diagnostic Medical Devices (IVDD) Directive. Both regulations make a number of important improvements in the conformity assessment of medical devices with intent: manufacturers of Class I devices must also collect and store product data, but only have to share information upon request.