The European Union's (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU.
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
FDA defines three regulatory controls for each medical device class: Class I medical device (low to moderate risk): General Controls. Class II medical device (moderate to high risk): General Controls and Special Controls. Class III medical device (high risk): General Controls and Premarket Approval (PMA)
The IVDR is immediately binding for all EU countries without requiring transposition into national law (as would be case with a Directive rather than a Regulation). Moving from a Directive to a Regulation aims to ensure a wider scope of protection and more effective implementation of the rules on IVDs.
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices.
A CE mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. It shows that the device is fit for its intended purpose stated and meets legislation relating to safety. It shows the product can be freely marketed anywhere in the European Unionl.
Eudamed is the European Databank on Medical Devices. It's a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
According to article 120(2) of Regulation (EU) 2017/475 on Medical Devices (the MDR), certificates issued in accordance with Directive 93/42/EEC will remain valid until 27 May 2024 at the latest.
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
CE certification costs can vary from below $ 100 to over $100,000. The CE marking costs totally depend on the kind of product and the certification procedure to be followed. The certification procedure, or procedures, that apply, is based on the intended use and the technical specifications of a product.
The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all of the Directives relating to that product.
Six steps to CE marking
- Find the CE directive(s) that apply to your product.
- Know the essential requirements for your product.
- Determine if you need third-party certification.
- Assess product conformity.
- Create and maintain technical documentation.
- Declaration of Conformity & affixing the CE Mark.
Today, there is no central database over CE marks or notified body certificates. The only way to check a CE mark is to validate the documentation, i.e. the Technical File and Declaration of Conformity. There is no such thing as a "CE certificate" or a "CE mark certificate", there are only notified body certificates.
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.
However, all certificates issued after 25 May 2017 will be void at the latest by 27 May 2024. After this date there will be no more valid AIMDD/MDD certificates. Is it possible to have valid MDR and AIMDD/MDD certificates in parallel until 27 May 2024?
As a French translation of the English “lol” and used in exactly the same way, mdr or mort de rire means to be dying of laughter.
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.
Medical devices legislationThe adoption in April 2017 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changed the European legal framework for medical devices, introducing new responsibilities for EMA and for national competent authorities.
On 26 May, 2021, the Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR). This allows MDR to provide a regulation which is consistent and fair to all member states, increasing the standards on quality and safety measures.
There are 3 classes of medical devices:
- Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
- Class II devices are intermediate-risk devices.
- Class III devices are high-risk devices that are very important to health or sustaining life.
Medical Device Reporting - 21 CFR Part 803The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner.
