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
Lašćinska cesta 40
Planinska ulica 13/2
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
Tel: +385 1 5588 297
Full company name
Short company name
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
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)
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
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)