All medical devices made available on the EU market must be CE compliant. But before affixing the CE marking symbol to a device, the product must undergo a very complicated, costly and considerably lengthy certification process to demonstrate compliance with all relevant essential health and safety requirements. This article presents a smart digital approach to CE marking medical devices that can cut costs and time to market drastically.

But before we tread further, let us go through the different concepts – CE marking and medical device.

What is CE marking?

CE marking is a symbol consisting of the letters’ CE’ and signifying the French phrase ‘Conformite Europeene’. It is a legal requirement allowing free trade of products, such as medical devices, within the European region. The CE marking on a product signifies a manufacturer’ declaration that a product is compliant with the minimum essential requisites of the relevant European health, safety and environmental regulations and directives.

The symbol must be affixed to certain products before they can be made available on the EU market. The presence of CE marking sign on a product further indicates that proper technical documentation supporting the use of the certification mark is accessible and, upon a request, can be supplied by the responsible party to the market surveillance authorities. In this regard, if the market authorities find that a product is not in compliance with the relevant legislation, they are empowered to take it off the EU single market and impose a penalty, such as a monetary fine or even imprisonment.

What is a medical device?

A medical device is any instrument, apparatus, appliance, implant, software, reagent, material or other article intended by the producer to be used, alone or in combination, for human beings for one or several of the following medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, and which does not realize its main intended action by pharmacological, immunological or metabolic means.

How to obtain CE marking for a medical device?

All medical devices placed and sold on the EU market must bear the CE marking symbol. But before affixing the CE marking to a device, the manufacturer of that device must demonstrate that the product is compliant with all relevant essential product health and safety requirements.

CE marking medical devices is a rather complicated, prolonged and costly activity due to the many steps in the certification process and the different parties involved (e.g. manufacturers, external consultants, third-party assessment bodies). Generally speaking, the CE marking process of a medical device includes the following steps:

  • Verify that the product is indeed a medical device
  • Determine the correct risk class of the medical device
  • Identify all relevant requirements
  • Where applicable, have a Quality Management System in place
  • Where relevant, pass a Notified Body assessment
  • Create a proper technical documentation
  • Create and sign a Declaration of Conformity
  • Register the product with the relevant national authorities.

Once manufacturers complete their medical devices’ CE marking process, they need to perform continuous post-market surveillance. In case of any incidents with their devices, they need to record and evaluate them.

Can you CE mark a medical device digitally?

If you were wondering how to acquire CE marking quickly, conveniently and digitally, you should search the web for a company called Clever Compliance.

Clever Compliance is a Swedish RegTech company that has been popular, among other things, for their digital approach to CE marking medical devices. They help MedTech companies of any size overcome the EU regulatory framework’s complexity and understand the product safety requirements for medical devices as best as they can. Their digital approach is expressed in the following:

  • CE expert guidance throughout the entire certification process
  • Countless digital workshops and consultations
  • Complete set of templates, including technical documentation and quality management system
  • Assistance with the Notified body conformity assessment.

Simply put, their experts in medical device certification guide companies throughout the CE marking process via web workshops and templates. If a Notified body assessment is required, and when possible, they help to book the assessment and filling out the application form. Clever Compliance also assists with filling out the product’s registration documents at the end of the process.

This digital approach to CE marking medical devices enables companies to cut their compliance costs and time to market drastically. And if that’s not enough, the Swedish company also provides a regulatory compliance management software that streamlines compliance activities and monitors the regulatory framework for changes and updates.