As of 26 May 2021, stricter rules apply to medical devices. In vitro diagnostics follow from 26 May 2022. This is a result of the 2017 European Medical Devices and In Vitro Diagnostics Regulations. This article gives an overview of the consequences.
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For whom have the rules changed?
Medical devices includes many products and services: from bandages to medical apps to pregnancy tests. The new European regulations may have serious implications for anyone who manufactures medical devices, and for their representatives. There are also many changes at hand for importers, distributors, and care providers. Under the new regulations, patients’ safety is safeguarded better. Also, the new Medical Devices Regulation supports innovation, so that devices continue to meet with the latest technological, scientific and practical developments.
Consequences for producers and manufacturers
Do you produce medical devices, or have them produced or improved? Then you have to evaluate the risk category for your product. Under the new regulation, several medical devices are in a higher risk category, and your medical devices have to meet higher demands before you can market them. A Notified Body will evaluate your products before they are admitted. If you have medical devices produced on commission, the company producing the devices will have to meet stricter demands as well. If you produce in vitro diagnostics medical devices, you will not only have to meet the stricter demands. Many IVDs will fall into a higher risk category. You will have to have the devices evaluated by a Notified Body, and provide clinical evidence that your products meets all requirements, according to the classification regulations.
Consequences for importers and distributors
If you import a medical device from outside the EU, you have to deal with stricter demands. Amongst other things, you have to register with the EUDAMED database, check if the product has CE-marking, and make sure it meets with the specific demands imposed by the new legislation. Do you distribute medical devices, for instance as a wholesaler, pharmacy or chemist? Then you, too, must comply with stricter demands. Amongst other things, you have to check if the importer you purchase the product from meets all the legal requirements. And if customers or caregivers complain or report suspected incidents, you must report back to the producer.
Consequences for care institutions and care providers
Care institutions and care providers like hospitals, care homes, GP’s or pharmacists must also meet the new rules. The revised regulation also poses demands on medical devices and in vitro diagnostics devices you yourself develop for use in your institution.
In all EU-countries, so-called Notified Bodies assess medical devices and their compliance with regulations. Medical devices that meet the legal standards are given a CE certificate. Without such a certificate, a producer is not allowed to market a device. Under the new regulation, the Notified Bodies themselves have to meet stricter demands. For instance, the rules for personnel qualifications have become stricter. Also, they have to conduct spot checks at production companies. To ensure that Notified Bodies meet the new demands, the government is running procedures to re-assess and re-appoint them. Only after they have been re-appointed can Notified Bodies start testing if medical devices meet the new requirements.
Inspection and supervision
The Health and Youth Care Inspectorate supervises several aspects of the Medical Devices Regulation. Its activities include supervision of:
- Netherlands-based Notified Bodies and their operations;
- The execution of clinical research in the Netherlands;
- Reports on incidents and solutions in the Netherlands;
- Market developments: this includes the operations of producers, importers, distributors and retailers.
The new rules make matters more transparent for patients. For instance: patients and care professionals will have access to the European EUDAMED databank. This databank provides information about medical devices that are available on the European market. That will help patients choose the medical device best suited to their needs. Another example: after they have received an implant, patients will be given an implant information card, with information about the implant and its producer. EUDAMED is expected to be ready for public access in May 2022.