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Bringing a medical device (MD) to one market is not easy; trying to maneuver multiple markets at the same time can be challenging. This article outlines major differences between the US and EU markets and considerations that should be looked at when a company wants to launch their product in both.
In Europe, medical device manufacturers must have a CE mark in accordance with EU Medical Device Regulation (MDR 745/2017). In the United States, they must receive clearance or approval through the US Food and Drug Administration (FDA). Regardless of the market, manufacturers must comply with applicable Quality Management System standards or regulations. For the United States, Quality Management System Requirements are outlined in 21 CFR Part 820. In the EU, manufacturers are required to follow Quality Management System for Medical Device Standard ISO 13485:2016.
Requirements of the latest version of ISO 13485:2016 are more similar to what is required by FDA Quality System Regulation (QSR).
In both the US and EU, regulatory controls and marketing pathways are based on the level of risk of the device and are necessary to ensure reasonable assurance of safety and effectiveness.
The most common marketing pathways in the US include:
- Premarket Approval (PMA): This is the most stringent type of premarket submission. The sponsor must provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use.
- Premarket Notification 510(k): The sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing.
- 510(k) Exempt: Devices are exempt from 510(k) notification requirements if they do not exceed the limitations of exemption stated in 21 862-892.
- De Novo Classification Request: Used for novel medical devices for which there is no legally marketed predicate device.
- Humanitarian Device Exemption (HDE): Used for devices that are intended to benefit patients with rare diseases or conditions.
As for the EU, manufacturers shall lodge an Application for Certification with Notified Bodies designated under EU MDR of its choice. The Notified Body is authorized by the national competent authority and by the European Commission to CE mark a medical device through the following steps: Evaluation of the technical documentation and the performance of an audit at the manufacturer’s and/or its strategic suppliers’ facilities to verify the correct implementation of the Quality Management System.
At the end of this process, the manufacturer draws up a Declaration of Conformity, registers the medical device in the national database (the future European database EUDAMED, expected completion in 2024) and affixes the CE mark to the product.
Classifications of medical devices in both the EU and US are based on possible risks of the product and its potential harm to the patient or end user. The FDA classifies devices as Class I, II, and III. Class III devices have the highest risk profile and while they are often used to sustain life, they are permanent implants, smart medical devices and life support systems that can present potential unreasonable risk of illness or injury. Similar to the US, EU classification is based on intended use and risks as follow: Class I (Class I, Class Ir, Class Is, and Class Im), Class IIa, Class IIb and Class III.
Combination products are defined as a medical device combined with another FDA-regulated product (e.g., drug, biologic, etc.). In the case of a combination product, it is necessary to contact FDA’s Office of Combination Products (OCP). In the EU, manufacturers are required to position drug-device combination products into the market as an integral device and market them as a “medicinal product” to seek a Notified Body Opinion (NBOp).
FDA registration is does not expire, unless there are critical changes to the device. Establishments that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. The registration is a two-step process which requires payment of the annual registration user fee and electronic submission of the registration and listing information.
In the EU, the certificate is valid for 5 years. To keep it active, the notified body carries out an audit every year at the manufacturer’s facilities. Audits with negative results can lead to the revocation of the certificate and the need to withdraw the products from the market. Similarly, unscheduled audits are performed at least once every three years. Once the certificate has expired, the Notified Body proceeds with an audit of greater duration and detail (with respect to the annual audit) and with the re-evaluation of the entire Technical Documentation.
In order to receive reimbursement in the US, the manufacturer must use coverage, coding and a payment system and receive approval from Centers for Medicare & Medicaid Services (CMS) or private insurance companies. The process can take three months to six-plus years.
In Europe there is great variability for medical device reimbursement. National Healthcare Systems are key stakeholders in some countries and may cover the cost of specific medical devices, while in other countries private insurance companies play a larger role. Additionally, considerations may also be required with local regulatory frameworks so reimbursement strategies must be customized for these variabilities.
Foreign companies outside of the US or EU shall utilize Local Representatives- in the form of a US Agent or European authorized representative.
Although the FDA recognizes and utilizes many universal standard organizations and their specific standards, not all standards are recognized or accepted. The FDA does publish all of their recognized standards and provides additional guidance documents on how devices shall be developed, tested, distributed and managed. In the EU, there are harmonized standards to verify compliance with requirements of Annex I of Reg. EU 745/2017. The list of harmonized standards is present in the Official Journal of the European Union (OJEU).
English is the language of documentation in US and the preferred language in Europe. The European competent authority can request all information and documentation necessary to demonstrate the conformity of a device in an official Union language determined by the Member State concerned. As for the language of packaging and other requirements in the EU, this is the language of the country where the product is to be marketed. In the US it is English.
