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Easy Start of CE Marking for mHealth

No need of dealing with all of the regulatory appliances and expensive consultants, start it yourself in 3 simple steps

Your risks of ignoring
EU regulatory

3 Simple Steps

1

Add product

2

Tick relevant definition

3

Get results in no time

Add product

Add product

As the first step, you would be asking to add a product name and short description. Each version of the product may have different features which can dramatically change final results. You should to differentiate it by giving specific names and describe what was changed or/and added in each version. So, when you get results you will understand the reason.

Designed to Ease CE Marking

  • Define if you need CE Marking
  • Find out which class is your App
  • Be prepared to QMS
  • Get your app to market faster

Easy to Use

Answer simple questions instead of studying complex regulatory directives

Save Costs

Save thousands of euros without involving expensive consultants to know basic information

Spend Less Time

Spend 3 hours instead of 3 weeks to know what you need to do

Our Products

Qualifier

Freeforever

medical qualification

Answer simple questions

Test as many product ideas as you like

No credit card required

Classifier

€ 250per month

medical classification

Find the specific medical classification of your product ideas

Answer simple questions

Immediate on-screen results

Test as many product ideas as you like

mHQ Certificate

€ 500per issue

results confirmation

Show investors the classification of your specific product

One page document issued by mhealthqa.com

PDF file download to attach to your business plan

Strategy Report

€ 2 000per product

guidance on EU regulatory compliance

25+ page report customized to your product

Interpretation of your product classification

List of necessary documents

Standards for your future Quality Management System

Don't be guessing

check your mobile health application!

Built within EU regulatory framework

mHealthQA.com makes CE certification manageable for mHealth startups and small businesses. The platform is built in accordance with the EU regulatory framework. Now, there is no need for you to read hundreds of pages of legal text. We read them for you!

EU Medical Devices Directive 93/42 as amended with 2007/47

MEDDEV 2.1/5 Medical devices with a measuring function (June 1998)

EU In Vitro Diagnostic Medical Devices Directive 98/79

MEDDEV 2.1/6 Qualification and Classification of stand-alone software (July 2016)

EU Harmonized Standard EN62304:2006 / A1:2015 Medical device software - Software life-cycle processes

MEDDEV 2.4/1 rev.9 Classification of medical devices (June 2010)

Frequently Asked Questions

What is CE Certification (CE marking)?

CE marking shows that your product has been assessed to meet EU safety, health and environmental protection requirements. It is valid for products developed both inside and outside the EEA. It is required for many kinds of products – including many types of health related software.

What is CE Certification (CE marking)?

CE marking shows that your product has been assessed to meet EU safety, health and environmental protection requirements. It is valid for products developed both inside and outside the EEA. It is required for many kinds of products – including many types of health related software.

Does my health application need CE Certification?

According to EU Regulations, CE Marking is required for some mobile health applications. Depending on the intended use of your app, it may be considered a medical device and be subject to the European Regulatory Approval Process leading to CE certification. So, you really should know how your app is regulated.

Does my health application need CE Certification?

According to EU Regulations, CE Marking is required for some mobile health applications. Depending on the intended use of your app, it may be considered a medical device and be subject to the European Regulatory Approval Process leading to CE certification. So, you really should know how your app is regulated.

Why would mHealth apps need CE Certification?

When health apps are used in potentially dangerous situations, life or death may depend on the software working properly. Basically to project the population, such software is required by EU law to follow specific regulations on Certification.

Why would mHealth apps need CE Certification?

When health apps are used in potentially dangerous situations, life or death may depend on the software working properly. Basically to project the population, such software is required by EU law to follow specific regulations on Certification.

In which countries is CE Certification required?

The CE marking is required for medical devices in the EEA countries (EU + Iceland, Lichtenstein and Norway) and gives access also to the Swiss market. 

In which countries is CE Certification required?

The CE marking is required for medical devices in the EEA countries (EU + Iceland, Lichtenstein and Norway) and gives access also to the Swiss market. 

On average you will expect:

Saves

€4500

on regulatory consultants

Gain

500 hours to spend

on product and business

Get

2 months earlier

to fundings, development and market


Your journey to fast and easy CE Marking starts here

Contact Us

If you have any questions or any improvement idea we would love to hear from you