Welcome back to our appointment with the news at Dispotech.
Today, using an interesting article published on the pharmatimes.com portal, we will talk about a "hot" and current topic that affects the manufacturers of medical devices.
The last European regulation on medical devices and in vitro diagnostics dates back to April 2017 – which came into force the following month - with production companies adapting by 2022. These new laws substantially change several rules on how medical equipment is manufactured: let's read it together and see what it’s all about!
The urgency of providing new laws in this sector has proven to be of fundamental importance due to the recent scandals that have indicated the flaws and obvious legislative gaps in the field of medical devices. Scandals that got into the news such as the toxic prostheses used by plastic surgeons or the DePuy scandal on metal hip prostheses have amply demonstrated, according to the European Commission, "the weaknesses of existing legislation".
The new EU provisions hope to improve the quality, safety and reliability of medical devices, with special consideration for the transparency of information for consumers and a great deal of importance given to the supervisory bodies on the market. Many changes have been made: we will try, briefly and in large groups, to illustrate them.
Quality, safety and reliability of medical devices - New products will now be subject to new European legislation owing to a new definition of "medical device". Along with traditional medical devices, the following come under the same heading:
- Contact lenses and other ophthalmic products;
- Substances used for treating skin and/or other fillers;
- Equipment used for liposuction, lipolysis or lipoplasty;
- Lasers for dermatological treatments such as skin rejuvenation, tattoo removal or permanent hair removal.
This translates into a large number of companies that will have to adapt to the new regulations and face the challenge of putting themselves on par with others. In the same way, companies already subject to legislation on the subject will have to review their products and adapt them to the new laws.
Transparency of information for consumers – New developments are on the way that also regard transparency for customers and traceability, which will be applied in a few years. Each device will have a unique device identifier (UDI); this UDI will then be logged onto the European database for medical devices (EUDAMED) and all data concerning it will be uploaded to give an overview of the device and its "path" on the assembly line. These new rules will serve primarily to prevent the counterfeiting of medical devices.
Market surveillance – There will be greater control on the market that distributes medical devices. In fact, the competent authorities will have more rights in conducting controls, revisions (even unexpected) for a maximum of 5 annual visits per company.
What do you think of these new regulations? Is there some aspect that you feel has been overlooked? Have your say by contacting Dispotech, your disposable excellence.