Medizinprodukte CE Kennzeichnung

The medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives (MDD) or Medical Device Regulation (MDR) by affexing CE marking logo on the product packaging. The CE mark is a legal requirement to place a device on the market in the EU terotory.

As a Regulatory Consultant and Authorized European Representative for MDD and MDR, EuropeCert has the technical expertise, experience and qualified manpower to provide complete solutions for CE marking services.

EUROPECERT is a turnkey (full scope) service provider from Germany to comply Medical Device regulation for Europe and America. This means whatever type or Risk class of device you manufacturer and wishes to market in Europe or America, EUROPCER has the technical expertise to provide appropriate technical Guidance and related services.

New Medical Devices Regulation is released by European commision

It is important that you prepare the Medical Device Technical File to meet the new requirements by end of 2019, so you are ready for MDR certification soon after your Notified Body is identified.

Frequently Asked Questions

How do I obtain CE marking? ( Process of CE Marking?)
- Appoint EUROPECERT as your consultant
- Identify the device and its models/variants
- Prepare Technical File
- Complete Harmonized Standard and product specific testing
- Select the Notified Body
- Implement EN ISO 13485:2016
- The answer to Notified Body review comments
- Complete Notified Body Site Audit sucessfully
How long the CE Certification process?

Depending on the risk class of the device and the Notified Body slected it may vary from 12 to 16 months
What could be the cost of CE Marking?
A] Estimated Fees for regulatory consulting / Technical File / Per GMDN code
- Class Is, Im & II a - 4500 Euros
- Class IIb – 6500 Euros
- Class III – 8500 Euros
B] Estimated Fees for Notified Body / Technical File / Per GMDN code
- Class Is, Im & II a - 8500 Euros
- Class IIb – 10500 Euros
- Class III – 15500 Euros
How to select a Notifed Body?

You can select Notified Body from NANDO website
http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main
What is the role of a CE Marking Consultant?
- Technical Guidance
- Technicla File preparation
- Label Review
- Identify the applicable Harmonized standard
- Identify the suitable testing laboratory
- Clnical Evaluation support
- Risk analsysis support
- Notified Body submission and Coordination till certification
What is the role of an EAR?

Read more >>>
What are the PMS and PMCF?

PMS - Post Market Survilance
There must be a system at your organization to keep up-to-date information gained from devices after manrketting. This is called PMS also referred to in Annex X (93/42/EEC), or Annex VII (90/385/EEC).

PMCF - Post Market Clnical Follow up
PMCF is a part of PMS.
The manufacturer has to provide long-term clinical data on the actual device to demonstrates safety, performance, intended use and stability of the marketed device. This is called PMCF
How to conduct the Clinical Evaluation?

European commission made it mandatory to follow MDDEV 2.7/1 Rev 4 latest guidance for how to conduct Clinical Evaluation. Clinical Evaluation must be conducted throughout the life cycle of a medical device. This is a never ending process and substantial supporting records should be maintained by the manufacturer.

MEDICAL DEVICE CE MARKING

New Medical Devices Regulation is released by European commision

Frequently Asked Questions