Overview of the new Medical Devices Regulation (MDR)

Medical devices (according to Article 3 of the Medical Devices Act, Official Gazette 76/13) are instruments, apparatuses, appliances, software, materials or other articles for human use that are used alone or in combination, including the software for diagnostic or therapeutic purposes, which is necessary for their proper use.

What are medical devices?

Medical devices do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, although their function may be assisted by such means. You can read more about medical devices here.

New regulation on medical devices

In May 2017, the new Regulation (EU) on medical devices (EU MDR 2017/745) was published in the Official Journal of the European Union, repealing the Medical Devices Directive (MDD 93/42/EEC). Following the publication of the MDR on 25 May 2017, certificates issued in accordance with the MDD shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.

Differences between the Regulation and the Directive

The proposed MDR differs from the current EU guidelines for medical devices and active implantable devices in several important parts:

  • Broader device range and changes in the classification
  • Appointment of a Qualified Person (QP)
  • Implementation of the Unique Device Identification system (UDI)
  • New, extended role of the European database on medical devices (Eudamed)
  • New requirements for notified bodies (NB)
  • Stronger clinical evidence and clinical evaluation
  • Increased requirements for post-market surveillance (PMS) and vigilance
  • STED format of technical documentation.

Postponement of the date of application of the new regulation

The date of application of the Regulation on medical devices was scheduled for May 2020, but due to the coronavirus crisis, its application has been postponed until May 2021 with the following explanation from the European Commission:

With patient health and safety as a guiding principle, the Council and the Parliament adopted on 23 April 2020 Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions. This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union, postponing the date of application for most Medical Devices Regulation provisions by one year. This postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.

The date of application of the Regulation on in vitro diagnostic medical devices (IVDR, Regulation (EU) 2017/746) remains the same (May 2022).

Medical devices undergo a conformity assessment procedure, registration at the Register of manufacturers and the Register of medical devices, and are also subject to a notification procedure for medical devices. The entire process can be time-consuming and exhaustive, but Marti Farm has many years of experience in working with medical devices, and with its team of experts provides the best possible service for its clients. If you are planning to certify a medical device or require assistance with any part of the regulatory procedure for medical devices, we invite you to connect with us.

Marijana Čop,  MPharm

Contact us

Headquarters

Lašćinska cesta 40
HR-10000 Zagreb
Croatia

Office

Planinska ulica 13/2
HR-10000 Zagreb
Croatia

Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
info@martifarm.com

Pharmacovigilance

farmakovigilancija@martifarm.com
Tel: +385 1 5588 297

Data usage consent:

Data usage consent:

Legal info

Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number

Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121

 

OIB
Share capital
Authorized representative

29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)

 

Bank account

HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)

 

Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121

OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)

Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)

All rights reserved Marti Farm ltd 2023. | Terms of Use | Privacy Policy

Share This

Share this post with your friends!

This website uses cookies. Click below to allow cookies. To adjust cookie settings and find out more, take a look at our Privacy Policy.

Cookie settings

Below you can choose which kind of cookies you allow on this website. Then, click on the "Save cookie settings" button to save your settings.

FunctionalOur website uses functional cookies. These cookies are necessary to let our website work.

AnalyticalOur website uses analytical cookies to make it possible to analyze our website and optimize for the purpose of a.o. the usability.

Social mediaOur website places social media cookies to show you 3rd party content like YouTube and FaceBook. These cookies may track your personal data.

AdvertisingOur website places advertising cookies to show you 3rd party advertisements based on your interests. These cookies may track your personal data.

OtherOur website places 3rd party cookies from other 3rd party services which aren't Analytical, Social media or Advertising.