CE MARKING FOR MEDICAL DEVICES
We never let you in the dark. We accompany you in every step of CE Marking for Medical Devices. According to the “Perga” we are the best and most economic regulatory service provider for EU MDR regulation. We are well-represented in Germany, India, Malaysia, Thailand, the UK, the USA, and Vietnam.
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CE Marking Importance
The CE marking for medical devices is a legal requirement for placing a device on the market in the European Union. Affixing a CE Mark to the product signifies that it meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations. CE Certification issued by Notified Bodies gives the authority to manufacturers to affix the CE Logo on the medical device and its packaging.
We are regulatory professionals who guide on specific requirements that must be met and obtain the CE Certification. The medical device industry generally covers reusable devices, equipment, disposables, implants, drug-device combination products, and home healthcare devices across all classes, spanning a diverse range of indications and state-of-the-art features.
We have the experience and expertise to prepare technical documentation covering core sections such as risk analysis, clinical evaluation, usability, etc. and submit it to any notified body of your choice.
We specialize in providing Medical Device CE marking documentation and audit support for obtaining CE Certification in the shortest time and lowest expenses.
CE Marking For Medical Devices Process
All medical devices need to have CE marking, 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 Marking for Medical Devices 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 CE Marking medical devices via a notified body.
CE Marking Advantages
CE Marking for Medical Devices is mandatory to sell in the European Union market of over 350 million wealthy consumers. Considering the advantages of CE marking, 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 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 consultant role is vital.
CE Marking and EU MDR 2017/745 Regulation
The Medical Device Regulation MDR 2017/745 replaces the old Medical Device Directive MDD 93/42/EEC. This means that the MDR, which came into effect in May 2017 and came into force on May 26, 2022, supersedes the MDD as the regulatory framework for medical devices in the European Union. Being a European regulation, it automatically applies to all EU Member States and the European Free Trade Association.
The core sections of the Medical Device Regulation (MDR) 2017/745 include
- Scope and Definitions
- General Requirements for Medical Devices
- Medical Device Classification
- Conformity Assessment Procedures
- Designate a Person Responsible for Regulatory Compliance
- Implement a Quality and Risk Management System
- Requirements for Technical Documentation File
- Conduct a Clinical Evaluation
- Post-Market Surveillance, Vigilance, and Market Surveillance
- Assign a European Authorized Representative (if Applicable)
- Obtain Certification by a Notified Body
- Prepare a Declaration of Conformity
- European Database on Medical Devices (EUDAMED)
- Unique Device Identification (UDI)
- Affix a CE Marking to the Medical Device
- Maintain Post-Market Surveillance
- Transitional Provisions
As a trusted regulatory partner, I3CGLOBAL offers comprehensive EU MDR consulting services ensuring early CE Marking for medical devices
We are a premium CE Marking regulatory compliance solutions provider for medical devices. If you require additional technical support and expert manpower to develop a technical file and coordinate with the Notified Bodies; That’s where our role comes in!!
CE Marking and role of I3CGLOBAL
We pride ourselves on being a top-tier provider of CE marking compliance specifically tailored for CE marking medical devices, with a primary focus on offering quality manpower and expert advice. In today’s complex regulatory landscape, manufacturers encounter numerous challenges from regulatory authorities
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 CE Marking for Medical Devices and entry into the EU market.
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Frequently Asked Questions
Is CE Marking For Medical Devices deadline under MDR extended ?
CE Marking for Medical Devices and Manufactures benefit
- Demonstrates to buyers and patients the essential EU legal requirements are met.
- Allows marketing of the device in all 30 member countries of the EEA.
- The majority of the Asian, African, Middle East and Latin American countries accept CE marking, to register in the respective countries.
- Indicates your device meets safety and quality regulations and standards.
- Attract Distributors and OBL/PLM manufacturers.