360Compliance provides comprehensive services for medical equipment certification according to European CE MD standards.
What is CE MD Certification?
CE certification of medical devices (according to European Community standards) is mandatory for all equipment used in therapeutic and diagnostic procedures within the European Union. The process is regulated by EU Directive 2017/745 and relevant industry regulations, including 90/385/EEC, 93/42/EEC, 98/79/EC, and 722/2012.
Why Is CE Certification for Medical Devices Important?
Only CE marking medical devices may be sold within the European Union. It confirms their conformity to the common inter-state standards, including those related to safety, efficiency, and convenience. The CE marking of medical devices is also considered equivalent to the national standards of Switzerland, Turkey, Australia, and some other countries. Thanks to this, the corresponding product marking gives you access to new markets.
Which Products Require CE MD Marking?
The CE mark medical devices can be sold within the European Union. This applies to equipment intended for therapeutic and diagnostic procedures. Special regulations apply to the following products:
- In vitro laboratory diagnostic equipment (for tests);
- Active implants, e.g. pacemakers;
- Products derived from animal tissue.
What Products Can Be Sold Without the CE MD Mark?
CE certification is not required if the product does not meet the definition of a medical device specified in EU Directive 2017/745 (MDR). In that case, other industry regulations apply to it, e.g. those regulating radio frequency or electromagnetic radiation. Products can also be sold without a CE certificate if alternative standards have been developed for them. This is the case for medicines, food products, cosmetics, and chemicals.
How to Apply for CE MD Certification?
The first step is to determine the type of device by the risk/benefit ratio. The easiest procedure is the CE certification of medical devices of Class A (I), which implies low risk. You can certify such devices yourself without applying to the authorities. If a device meets the harmonized standards of the European Union, the manufacturer only needs to draw up the technical documentation and perform tests in an accredited laboratory.
To obtain CE marking for Class B (II) and C (III) medical devices, they must be tested in a controlled environment under the supervision of representatives of the notified body. This is also applicable to Class A devices that do not meet the harmonized EU standards.
How to Get CE MD Certification?
The process for CE certification of medical devices consists of six steps:
- Demonstration of conformity — the manufacturer declares the product’s conformity to each standard that applies to that type of goods.
- Identification of medical device classes in accordance with EU Directive 2017/745.
- Selection of a testing method that fully confirms the safety, effectiveness, and usability of the device.
- Compilation of technical documentation describing the appearance, functions, software, and interface of the device.
- Drawing up the EC MD declaration of conformity.
- Submission of an application for certification to the regulatory body, if required.
The list of necessary documents and the structure of the testing procedure depends on the type of medical device. Testing of devices is performed by an accredited laboratory. Among its staff should be specialists with medical education, who are allowed to use the equipment for its intended purpose. Such testing must cover the full range of device functions.The timeframe for issuing the certificate varies depending on the niche and the application of the device. The average time for a Class A device is 4 to 8 weeks. Clinical testing of Class B and C devices can take several months.
Manufacturer’s Responsibilities Related to CE MD Certification
To obtain CE marking of medical devices, the manufacturer must:
- Comply with EU Directive 2017/745 when developing the device;
- Conduct testing and clinical trials;
- Implement a quality control system in accordance with ISO 13485;
- Conduct a detailed risk analysis and specify the risk-benefit ratio in the documentation;
- Update documentation when changes to EU standards are made;
- Provide all requested information to local authorities and authorized bodies;
- Implement an after-sales service system;
- Assign a unique identification number to each device;
- Register in the EUDAMED database.
Responsibilities of the Distributor of Medical Devices
A company that sells equipment within the European Union must be an authorized representative of the manufacturer or developer. To distribute CE-marked medical devices, you must make sure it conforms to the following requirements:
Sold only after receiving documentary proof of compliance with EU Directive 2017/745;
Delivered to customers unchanged (as designed by the developer);
Products are withdrawn from sale and recalled from customers if they do not comply with current standards.
Quick CE MD Certification with 360Compliance
We provide a full range of CE certification services for medical devices. Our employees provide assistance with all the stages of this procedure from evaluating the legal environment and determining the class of equipment to the paperwork and cooperation with authorized bodies. We guarantee transparent prices, clear deadlines, and convenient technical support. Get your certificate quickly and with a minimum of effort by leaving an application on our website to learn more about our services!