Obtaining the EU MDR Medical Device regulation is considered a new revolution that will change how medical devices are traded on the European market. The EUMDR 745 2017 replaces the previous medical device directives and the active implantable medical device directives. Even though these changes are relevant, they are coming with a huge financial burden to the manufacturer's different stakeholders wanting to be in the European Union.
In this blog article, we will discuss some of the costs that are associated with acquiring the EU MDR certificate and also provide estimated numbers that will provide you with an idea of what to expect before starting the process. Actual costs of obtaining the EUMDR certification usually depend on different factors that include; the complexity of the medical advice, the number of conformity assessments required, and the scope of the certification process. Hence to find out a clear estimate of the costs of acquiring the EU MDR 2017, consult your notified body and carry out extensive research.
EU MDR gap analysis: Medical device manufacturers are currently required to identify and analyze areas in their quality management systems (QMS) that might not comply with the EU MDR 745 2017. This process is required to ensure that manufacturers can improve compliance in their systems. Depending on the size and complexity of the organization, these costs can range between €5000 to €50,000. Also, costs will vary based on the complexity and the size of the quality management system of the manufacturer.
Once the notified body approved the quality management system of the manufacturer, they can apply for the medical device regulation certification. This process involves a review of the manufacturer's technical documents and the QMS and an audit of the manufacturing facilities. These costs can go beyond €100,000, depending on the class of your medical device.
Cost of the conformity assessment: This is one of the most important parts of the Medical device regulation certification process. Notified bodies are required to assess and provide technical documentation as well as perform some tests on the medical devices to ensure that they meet the requirements of the EU MDR 745/2017. The pricing of this assessment will vary based on the number of factions. Class I Medical Devices have relatively low pricing that can even be lower if manufacturers use a third-party notified body. Class IIa manufacturers have higher costs than class I manufacturers. Because Class IIb manufacturers have a more complex product, they are likely to pay around €10,000 to €20,000. For class III manufacturers, costs should be expected to be as high as €50,000 depending on the product and the notified body.
EU MDR Certification: This cost will also vary depending on the type of certification that a medical device manufacturer needs. Manufacturers are advised to make use of third-party notified bodies, that are accredited by the EU to assess their medical devices and IVDs. The cost of acquiring this certificate varies from the notified bodies, the type of medical devices, and the complexity of the assessments.
Notified body costs: The notified body is expected to pay annual fees to the European Commission. These are usually transferred to the manufacturer and would cost between €4000 to €16,000. Besides this annual fee, manufacturers will have to pay for the work of the notified bodies and this can cost up to €50,000 depending on the complexities of the product.
EUMDR Post-Market Surveillance: manufacturers are required to have a post-market surveillance plan that will ensure proper monitoring of their products once they are on market. The products need to be safe and in proper working condition once they are placed on the European market. This cost can range from €5000 to €50,000 depending on the complexity and size of the company and the markets they are planning to place the market into. Manufacturers usually, outsource this activity to third-party organizations to ensure quality surveillance and vigilance of their medical devices and IVDs
Training and Education: Most manufacturers might assume this is an irrelevant cost, given that their employees are already aware of the process. But it is a requirement by the EU to have this plan in place that ensures training of the employees on the EU MDR requirements and that employees have the skills and knowledge to comply with the medical device regulations. Training can be focused on EU MDR distributor requirements, packaging requirements, and many others. Of course, costs will depend on the size of the company. For bigger companies, these costs can reach 20,000.
Labeling and packaging for medical devices: Due to the new EU MDR requirements, medical device manufacturers are required to also comply with the new MDR labeling requirements. This is fostered to ensure the safety of products and usage by the right audience. These costs will also depend on the complexity, the number of countries you want to place your product in, and the partners involved.
Clinical trials: This is one of the most expensive aspects of acquiring an MDR. In this process, manufacturers are required to carry out trials to ensure that their product is safe for usage on the European market. This process allows manufacturers to redesign their products while in the process to ensure it fits the EUMDR standards. This process can vary from €50,000 to €500,000. To understand more about the clinical trials on the European medical device market, manufacturers are advised to read the clinical trial regulation EU no 5362014
It is also important for manufacturers to know that after acquiring the EU MDR 745 certification, they will be required to have recertification for their products every few years. The costs in this process may include consulting the notified body and many other costs. Depending on the product you are a manufacturer or acquiring certification for, you are likely to range between a few hundred euros to tens of thousands of euros.
All in all, acquiring the EU MDR 745 certification is a complex and costly procedure but also an important aspect for manufacturers. Companies need to budget accordingly and carry out market research before tempting to enter the European market. Research on whether there is a market for their product on the European market can be a great point to start before investing a million dollars on acquiring a certificate. Having the EU MDR 2017/745 on the European market provides some level of trust market that your products are safe and effective for usage. If you are not sure of your products and still want to enter the European market, feel free to contact your notified body or have a free consultation call with our VP of Healthcare - Stephen Viljoen.
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