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For CE Marking MDR & IVDR transitions and new Certifications.


mdr ce marking

MDR CE Marking

Medical Device Regulation (MDR) replaces the Medical device Directives (93/42/EEC)

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MDR / IVDR CE Marking

MDR / IVDR CE Marking

Before placing them on the European Market goods sold must comply with MDR & IVDR.

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mdr classification

EU Classification

As per MDR Article 51 Medical Devices are divided into class I, Is, Im, Ir, IIa, IIb and III.

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medical device testing

Testing of Medical Device

These tests should be performed by certified laboratories to prove that the device is safe.

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technical file

Technical File

Technical File for medical device is a must for all type of devices regardless of the risk classification.

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mdr clinical evaluation

Clinical Documentation

The clinical evaluation of a medical device extends throughout the entire life cycle of the device.

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iso 14971 rmf

Risk Analysis

The Risk Analysis is the starting phase of the risk management process for a medical device.

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software ce marking

Software CE Marking

Software CE Marking depends on the type and risk class of the software in question.

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ce mark consultants

CE Mark Consultants

CE Marking Consultants help manufacturers to introduce a new device into the EU market.

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ce marking fees

Cost of CE Certification

We are sure, below information will be very helpful for those planning for MDR CE Marking.

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eu representative

EU Representative (E.A.R)

EU Representatives performs certain duties under new European Medical Devices Regulation.

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post market surveillance

Post Market Surveillance

As per Medical Device Regulation, manufacturers must conduct PMS as outlined in article 83.

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Notified Body

Notified Body

European member states designated some organizations known as Notified Bodies.

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conformity assessment

Conformity Assessment

CA activity is the process describing whether the requirement of the MDR relating.

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obl ce marking

OBL CE Marking

OBL practice is accepted by the EU and is common within the Medical Device and in IVD industry.

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eu udi

EU UDI System

EU MDR mandates the use of a Unique Device Identification (UDI) system which will allow.

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EU Device Registration

EU Device Registration

It is mandatory to register and list the devices within EU Territory with the help of E.A.R.

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kit systems procedure packs

Kits & Procedure Packs

MDR 2017 article 22 details about CE Marking of "Systems" or "Procedure Packs".

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vigilance control

Vigilance System

EU MDR Section 2, article 87 mandates for reporting of serious.

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ce marking faq

FAQ's

More information about EU MDR and EU IVDR CE Marking.

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ce marking download

Downloads

Procedures, SOP, Forms and Standards.

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