The European medical technology market was estimated to be worth €140 billion in 2020. This is a promising market for non-EU medical device manufacturers. First, they need a CE Mark according to the risk classification to export to countries in the EU. What Is CE Marking for Medical Devices? CE stands for Conformité Européenne. The CE marking indicates that the product has met the General Safety and Performance Requirements set by Medical Device Regulations (MDR). Medical devices logistics are classified into classes, similar to that of the Food and Drug Administration in the U.S. The CE Mark appears on products traded on the extended Single Marker in the European Economic Area. The mark signifies that the product meets the safety, health, and environmental protection requirements set by the European Commission. The MDR classes are the following: Class I These are considered low-risk devices like bandages, surgical instruments, and wheelchairs. Class IIa These are medium-risk devices that require the involvement of a notified body for export. Examples are hearing aids, catheters, and short-term contact lenses. Class IIb These products are considered medium to high risk, such as ventilators, long-term contact lenses, and incubators. Class III These medical devices are considered high-risk and are subject to strict regulatory requirements. Examples include pacemakers, prosthetics, and other devices that require permanent monitoring. What Is a Notified Body? Do You Need One? A Notified Body (NB) is a third-party organization designated by an EU country to assess product compliance before it can be sold on the market. In this case, the NB will assess medical devices and in-vitro diagnostics (IVDs) and their compliance with regulatory requirements. All medical devices except those that fall under self-certified Class 1 (not sterile, not a measuring device, and not a reusable surgical instrument) require NBs for EU export. If you need support with the complexities of setting up your own EU entity, kindly reach out to GrowthImports, the best EU Importer. How Are Medical Devices Classified? All medical devices undergo stringent technical documentation for CE marking. Factors that affect classification are the characteristics of the devices. Are they non-invasive? Most devices that do not penetrate the body are typically considered Class I. However, some exemptions would result in the product’s higher classification. Invasive (enter the body through the skin or any orifice) and active (require an energy source) devices are classified higher. Duration of use and reusability also affect classification. Steps to Obtain CE Marking for Your Medical Device Create Quality Management System A Quality Management System (QMS) includes all policies and procedures related to every step in the design, manufacture, and distribution process of your medical device. This is a mandatory requirement for any company that wishes to enter the medical device market. Classify Your Medical Device The most crucial step is to correctly classify your medical device. The MDR’s decision tree indicates specific rules that will help determine your device’s associated risks and classify it accordingly. Create Technical File
Affix the CE Mark When all requirements are satisfied, you can create a Declaration of Conformity, and the CE mark will be placed on your medical device. Obtain Certification Unless the device is under self-certifying class I, you must apply for certification of conformity to essential requirements from an NB. You can partner with CE marking companies for support throughout these steps. More Information? GrowthImports We provide non-EU medical and in-vitro device manufacturers with independent European-wide importing services compliant with Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) requirements. Import your medical goods Into Europe with our hassle-free market access Importing service while maintaining flexibility, compliance and Increased quality standards.
With over 30 years of combined experience, Growth Imports is dedicated to ensure the facilitation of a compliant and smooth international MDR/IVDR compliant importing process in the European market. GrowthImports BV Plesmanweg 9 | 7602 PD Almelo The Netherlands T: +31 85 13 08 966 E: [email protected] W: www.growthimports.eu
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