CE FOR MEDICAL PRODUCTS DONE!
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Special features of conformity assessment and CE labelling of medical devices
Medical devices are categorised into three risk classes. Requirements are regulated in 2 ordinances:
- Medical devices are generally categorised into three risk classes according to their intended use (categorisation is carried out by the manufacturer): Class 1 are non-invasive, non-sterile medical devices that do not have a measuring function. Here, conformity assessment procedures and CE labelling are carried out by the manufacturer, with special preparation in accordance with specific medical device standards. easyCE can support you with this.
- For medical devices of the Class 2 and 3 certification by a "Notified Body", such as TÜV, DEKRA or MEDCERT, is required.
- Software can also be a medical device and fall under the CE labelling requirement. For example, clinical information systems, clinical decision support systems and smartphone apps. Please contact us to find out more.
From 26 May 2021, the requirements of the new Medical Devices Regulation (EU 2017/745) and the In Vitro Diagnostics Regulation (EU 2017/746), which replace the Medical Devices Directive (93/42/EEC), the Active Implants Directive (90/385/EEC) and the In Vitro Diagnostics Directive (98/79/EC), will apply. Due to the coronavirus pandemic, this deadline has been postponed by one year to 26 May 2021. There is then no grandfathering and all medical devices must be tested and certified in accordance with the new requirements.
REFERENCE PROJECTS
Conformity assessment, CE labelling and instructions for use for a permeate treatment system.
easyCE supports the entire conformity assessment procedure including the instructions for use for a permeate treatment system, i.e. the treatment of water as a preliminary stage for dialysis machines. In terms of design, it was important for the system to maintain and achieve a high degree of purity, which also had to be taken into account during the risk assessment.
Requirements research for dental implants.
easyCE provides support in researching a wide range of technical requirements for a dental implant. In particular, the technical properties with regard to the angle and inclination of the threads, as well as materials such as titanium, had to be determined.
Other perefence projects:
FAQ
According to which directives must medical devices bear a CE mark?
The conformity assessment and CE marking of medical devices is still regulated throughout Europe by three directives until 26 May 2021. These are as follows:
Is there grandfathering for medical devices whose conformity and CE labelling were carried out in accordance with the previous directives?
No, there is no grandfathering and all medical devices must be tested and certified in accordance with the new requirements.
Which types of medical devices must bear the CE marking?
Medical devices are categorised into three risk classes according to their intended use:
Do software and apps for use in the medical sector also require CE labelling?
Yes, software can also be a medical device and require CE labelling. For example, hospital information systems, clinical decision support systems and smartphone apps
As a manufacturer of medical devices, what do I have to take into account for conformity assessment and CE labelling?
easyCE will be happy to help you identify the directives and standards that apply to your specific product. The next step of product analysis and
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