In 2017, the new European Medical Devices Regulation and the In Vitro Diagnostics Regulation came into force . Both regulations came with a transition period, to make it possible for all concerned parties to adjust their processes where necessary. As a result, stricter rules will apply to medical devices from 26 May 2020, and to in vitro diagnostics from 26 May 2022. The new European regulations may have serious implications for you if you manufacture medical devices, and for your representative . There are also many changes at hand for importers, distributors, and care providers. Medical devices includes many products and services: from bandages to medical apps to pregnancy tests. You are well-advised to prepare in time. Under the new regulations, patients’ safety will be better safeguarded. 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. Once the new regulation comes into force, several medical devices will be in a higher risk category, and your medical devices will 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 will have to deal with stricter demands. Amongst other things, you will 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 prepare for 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 will have to meet stricter demands. For instance, the rules for personnel qualifications will become stricter. Also, they will 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.
Patients do not have to prepare for the new rules, but they will notice the consequences. The new rules will make matters more transparent. For instance: patients and care professionals will have access to the European EUDAMED databank. This databank gives 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.
The EU offers links to information on what the consequences will be for manufacturers and importers if the UK leaves the EU without a deal. Make sure you check this information regularly.