Your shopping cart


Total (VAT incl.)

VAT (21%)
You have not added any reports to the cart yet.
Request reports
If you prefer to place your order via e-mail
contact us at:

Medical Devices

CE Marking / CE Certificate

In order to market medical devices in Europe, they must comply with the applicable regulatory requirements. The European Council has approved the new medical device regulations MDR 2017/745 (formerly MDD 93/42/EEC and AIMD 90/385/EEC) and the in vitro diagnostic medical device regulations IVDR 2017/746 (formerly IVDD 98/97/EEC), which are in force since 2017.

These new Regulations mainly incorporate:

  • New rules for the classification of products.
  • Improved clarity of the requirements compared to the previous Directives.
  • Clearer rights and responsibilities for economic operators are established.
  • Stricter supervision of Notified Bodies.
  • Stricter provisions for post-market surveillance.
  • From May 2020, it will affect non-medical products listed in Annex XVI of the MDR.
  • Products that under the MDD and IVDD directives did not require Notified Body assessment, now DO require it under MDR and IVDR.

Therefore, all economic operators that manufacture, group, sterilize, distribute and import medical devices must review the degree to which the entry into force of the new regulations affects them.

In Azierta we support manufacturers to obtain the CE marking of medical devices according to the new Regulations or to update their product certifications to the new requirements.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience


Leading innovation

Client oriented

100% client oriented


We help you in everything you need. Contact us by filling out the form or book an appointment for a video call with one of our experts.

We use "cookies" to improve your experience on our site. Cookies enable us to tailor messages and display ads to your interests. They also help us understand how our site is being used. By continuing to use our site you consent to use our cookies.

We are at your complete disposal for any inquiry

Thank you for getting in touch! We will contact you as soon as possible to help you out
There has been an error while submitting your form, please try again, or call us at 912 77 10 76

How can we
help you?

    There was an error submitting your details, please try again.

    Your request has been submitted

    Our team is working
    to get in contact you
    as soon as possible

    Thank you
    very much!