The Interactive Guide Under The New EU Regulations on Medical Devices for Manufacturers has Launched
This Chart is taken from Medicines & Healthcare products Regulatory Agency: https://www.gov.uk/government/news/introductory-guide-to-new-medical-device-regulations-launched
Medical devices are increasingly becoming everyday devices, especially in the case of home use medical devices. To ensure these medical devices are safer and perform as intended, they must comply with the relevant EU legislation.
The Medicines and Healthcare products Regulatory Agency (MHRA) has created an introductory guide to make sure non-experienced and experienced manufacturers are aware of their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). The guide intends to help manufacturers to get to grips with what has changed and what they may need to do for a smooth transition in 2020, when the regulations come into effect. Here, Auxergo has adapted the MHRA‘s statement to summarise the new regulations.
The new regulations will apply across EU Member States from 26 May 2020 and 2022 respectively. The Introductory Guide will help non-experienced manufacturers who may be looking at the regulations for the first time, and will also help experienced manufacturers navigate the changes in the new regulations. The new regulations will include clearer obligations for those involved in manufacturing and supplying devices, a greater emphasis on trace-ability throughout the whole supply chain with the introduction of a unique device identification (UDI) system and new standards for clinical evidence. They also set out more rigorous vigilance reporting requirements, including new reporting timescales, as well as clearer requirements on what a manufacturer’s post-market surveillance system should comprise of. The new regulations are a balancing of responsibility and an increasingly technological approach to healthcare.
Some devices will become regulated under medical device legislation for the first time. Annex XVI of the MDR lists six categories of devices similar to medical devices that do not have any medical benefit and are used for other purposes, such as dermal fillers, non-corrective contact lenses and brain stimulation devices. These devices carry much of the same risks as medical devices and – under these new Regulations and detailed ‘Common specifications’ to be published by the European Commission – their manufacturers, importers and distributors will be regulated in the same way.