Medical Device CE Marking Services!

All medical devices need to have CE mark on it, but some of the devices need to comply with some requirements. Maybe those devices cannot be CE marked. For example, drug-device combination products that need NBoP are different from normal requirements.

Medical Device CE Marking requirements are slightly different for each class and rule. The simplest devices with less risk are simple to CE mark but the high-risk class devices need a third party to check any documentation. Once our product CE is marked, it can be sold anywhere in the European Union.

The basic process of CE Mark starts with identifying the device, models, variants, accessories, consumables and what kind of standards are needed for the device. Product risk classification is also an important requirement. The product needs to comply with the general safety and performance requirements, so these are a list of requirements that apply to every medical device.

The medical device manufacturing process must align with product-specific standards and harmonized standards. The conformity assessment procedure or the route of CE marking needs to be identified. Sometimes some risks are unavoidable, but the benefits will always outweigh the risks and it should be justified with supporting evidence.

If a manufacturer is outside the European Union, they must appoint an EU Authorized representative before applying Medical Device CE Marking via a notified body.

Medical Device CE Marking is mandatory to sell in the European Union market of over 350 million wealthy consumers. Considering the advantages of CE Mark, all manufacturers are forced to apply for CE certification, not only in Europe but also in other parts of the world. Large and corporate device manufacturers usually have sufficient staff in the regulatory affairs department.

In the case of small and medium-sized companies that do not have much technical expertise or full-time employees, they are confused and uncertain of what is required to obtain a medical device CE mark, including what documents and how much it will cost.

For small and medium-sized companies, it is difficult to prepare technical files because they usually lack knowledge and previous experience for the sizeable tasks involved as per MDR technical documentation. Usually, this gesture in a CE Marking consultant role is vital.

We pride ourselves on being a top-tier provider of medical device CE Marking, with a primary focus on offering quality manpower and expert advice. In today’s complex MDR rules, manufacturers encounter numerous challenges from notified bodies. These challenges necessitate additional technical support and expert manpower to effectively navigate interactions with notified bodies and uphold the ongoing validity of CE certificates. This is precisely where our expertise shines

Our dedicated team of professionals is equipped with the knowledge and experience to provide manufacturers with the necessary guidance and assistance at every stage of the MDR 2017/745 technical documentation and certification process. From initial development to engagement with notified bodies and ongoing interaction and file updation, we ensure that our clients are well-implemented to meet and exceed MDR 2017/745 requirements, thereby facilitating early medical device CE Marking and entry into the EU market.