Questions about the European MDR answered

1. Questions about the European MDR answered First and foremost, question must have to mind that why MDD was to be re-written in the form of MDR. Regulation keep changing through periodic updating, but this is major change where many changes were incorporated in new document called Medical device regulation (MDR) The European (MDR) is going to be a new set of regulations that governs the assembly and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products within the European marketplace. 1.Why did the MDD need an update? With the progress of IT industry, more and more software started coming and its use in medical device also started. This came into form of an application or governing medical devices where patient can also see his/her own monitoring. During old days when MDD was written this did not exist. So, need to regulate such development, MDR was born. There is a growing push for transparency of medical device technical information to the overall public. These factors combined are a number of the explanations that the MDD is being replaced with a replacement directive which will encourage wider compliance with standardized medical device regulations throughout Europe. 2.How is the new MDR structured? MDD is 60-page document as against the MDR is 174-page document. It contains introduction itself running into 13 pages, 10 chapters describing 123 articles and 17 annexes. Apart from above, 42 implementing acts and 12 delegating acts are also published which further clarifies implementation.

2. 3.What are the major changes in the MDR? Compared with its predecessor, the MDD, the new European MDR is a smaller amount focused on the pre-approval stage of medical device manufacturing, and instead, promotes a life-cycle approach to medical device regulation. While the old MDD essentially served as a manual for a way medical device companies could get their CE marking and obtain to plug, the new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for his or her products throughout the product lifecycle. It also needs policies and procedure in line with ISO 13485 to make standardise practice. 4.What devices are covered under the MDR? The MDR defines the term "medical device" as an "instrument, apparatus, appliance, software, implant, reagent, material, or other article" that is used for any of the following: Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention Investigation, replacement, or modification of an anatomical, physiological, or pathological process Providing data via in-vitro examination of samples derived from a human body. So even software which is invisible can also become medical device if it is created meeting any of above requirement. New regulation wants CE marking even for supporting items for devices like products which are use for cleaning, sanitizing and sterilising medical devices. The new and very important inclusion in MDR is annex XIV which lists many items which were not part of medical devices. Ex. Contact lens and lens care products, silicone implants for breasts, high intensity radiation equipment for hair and Tattoo removal. So, all those companies who were in the business of above will now come into high compliance level as per MDR. 5.Apart from KEY changes describes above, Device traceability is now important, and it will be governed through UDI (Unique device identification). The marking of DI (device identification) with PI (Production Identifier. QMS is the one which will get affected and old document will need lot of changes to include new nomenclature as per MDR. New documents will be needed for Risk assessment and post marketing surveillance for new as well as existing devices.