Medical Device CE Marking
We are Medical Device CE Marking Consultants and Regulatory experts for new European Medical Device Regulation (EU MDR 2017/745) and Invitro Regulation (IVDR 2017/746)
Major Reasons Customers Select MedDeviceCorp.
1. We develop the Technical File with client inputs, Submit to Notified Body, do all corrections and update Technical File as per Notified Body review comments. We hand over the Technical File to client only after CE Certification issued.
2. We reduce the expensive travel and accommodation cost by doing everything in cloud. Every small change in documents can be visible to client from any part of the world.
3. Our Technical documentation is done using QARA software which is 40% faster and more perfect with simple English language.
4. Largest pool and Regulatory & CE Marking Consultants, Lead Auditors, Clinical Experts stationed in multiple countries working full time.
5. Lowest price guarantee with highest quality of service for CE Certification.
Additional Benefits of Our CE Certification Service.
- Turnkey service for Medical Device CE Marking approval.
- Any Notified Body of choice can be arranged for the CE Certification.
- Good reputation among leading Medical Device CE Marking Notified Bodies across the Globe.
- Worldwide offices and associated Laboratories.
- European and US Representative Inhouse service.
- Inhouse Clinical Experts
- Special techniques to avoid a smaller number of company employees for the documentation and overall CE Marking approval process.
MDR Notified Bodies for Medical Device
Our CE Marking approval process include support for Identification of Medical Device Notified Body and coordination with Notified Body until receive CE Certification.
From May 2020 new Medical Device Regulation will come into effective. Notified Bodies approved by EU commission as per new regulation only can issue CE Certificate from this date.
Role of MDR Consultant in the Technical File Preparation
Technical File or Technical Documentation is to demonstrate the device in scope of CE Certification complies with European Medical Device Regulation in terms of safety, efficiency and performance. Compiling your Technical File with Medical Device Regulation is a task and overall certification lead time and CE Marking approval.
MEDDEVICECORP takes up the challenge by developing the Technical File Offsite from the information provided by customer thereby reduces the huge travel and accommodation cost of consultants. Our documents are developed in cloud so the clients can monitor day to day progress. We have a fixed fees system payable based on the progress. No surprises!!!
We also take up the responsibility of answering to Notified Body in case of any concerns or additional document request from Notified Body till CE Marking approval for your Medical Device.
New Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) will change CE Marking and Technical File requirements for all Notified Body Medical Device CE Certified products till date as per MDD 93/42/EC & IVD 98/79/EC.
The CE Mark Certificate is mandatory requisite for all Medical Devices manufactured and marketed in European Economic Area (EEA). The CE Mark Certificate is a proof of compliance with essential requirements of the Medical Device Directive (MDD).
The Notified Body is permitted to assess whether a Medical Device meets certain standards and issue CE Certificate. A Notified Body is an organization that has been accredited by a Member States in Europe
Compliance to Medical Device CE Marking is a difficult task. Manufactures and private label manufactures should appoint experienced CE Marking service consulting companies to accomplish the objective on time.
Medical Device CE Mark is widely accepted across doctors and healthcare practitioners across the globe as a mark of quality. CE Marking Medical Device – Most manufacturers in medical electronics, medical software, active medical device, Implant(s), Large medical equipment’s go for CE Certification.
The major hurdles in medical device CE Marking
- Identification of Harmonized Standards.
- Identification of medical device class and rule justification.
- Identify external laboratories for conducting the tests.
- Preparation of Technical File.
- Identify Notified Body.
- Technical File submission, Coordination and Onsite Audit.
- ISO 13485 Implementation.
Medical Device CE Mark Certification Cost?
The Cost of CE Marking depends on the following factors
- Intended Use/ Application of the Medical Device.
- Type and Models of the Medical Device planning for CE Certification.
- Notified Body selected for CE Certification.
- Standards Identified and there testing, and reputation of external Laboratories selected for Testing.
- CE Certification consultants’ fees based on Class and number of Models/Variants.
MEDDEVICECORP can assist worldwide manufactures working remotely and onsite with the MDR/IVDR transition process. Contact us by writing to firstname.lastname@example.org or call to the nearest location.