MDD is short for Medical Device Directive while MDR stands for Medical Device Regulation, and May 26th 2021 marked the transition from MDD to MDR. The transition had been underway for some years and was scheduled to take place on May 26th 2020, but was postponed one year to May 26th 2021 due to the COVID-19 pandemic.[1]

What is a medical device?

Medical devices can be defined as “products which are used to diagnose, prevent, relieve or treat a disease, disability, injury, etc. There are more than 500,000 different types of medical devices available, covering anything from wheelchairs and glasses to pacemakers, mobile phone apps and state-of-the-art surgical equipment. Medical devices are grouped into four classes known as I, IIa, IIb and III, with Class I being the lowest risk and Class III being the highest risk” [2]

Based on the above definition and the functionalities of the See Far solution, it is defined as a medical device – at this time still a non-CE marked medical device. The present project will pave the way for future work on obtaining a CE-mark as medical device.

Directives and regulations

Previously three medical device directives were applicable within EU: [3]

  • 1998: Directive 98/79/EC of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices (IVDMD) [4]
  • 1993: Council Directive 93/42/EEC on Medical Devices (MDD) [5]
  • 1990: Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) [6]

Due to developments in the field over the past years, as well as divergent interpretations of the directives etc., there was a need to revise the directives and bring them up-to-date. The three directives are over the next years consequently being replaced by two regulations.

The two new regulations entered into force on May 17th 2017.[7] As of May 26th 2021 the MDR – Regulation (EU) 2017/745 [8] – now applies and amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repeals Council Directives 90/385/EEC and 93/42/EEC.7

On May 26th 2022 the IVDR – which is the regulation on in vitro diagnostic medical devices (Regulation (EU) 2017/746 [1] – will apply repealing Directive 98/79/EC and Commission Decision 2010/227/EU. 7

While many of the fundamentals may remain the same, differences exist. With the implementation of MDR there is among other things a greater focus on safety e.g. highlighted by a more strict pre-market control of high-risk equipment, and increased requirements for manufacturers regarding post-marketing surveillance as well as other initiatives, which all in all will help ensuring better protection for public health in the medical devices sector. [2] [3] [4]

For research and innovation projects with medical devices initiated before May 26th 2021 it is important to notice, that these projects are allowed to continue with the approval obtained under MDD. It is important to note that the clinical investigation must both have been approved by competent authorities, and that a study specific activity must have been commenced before May26th 2021. Otherwise projects may face re-approval according to new MDR.

Manufacturers placing new devices on the market after May26th 2021 should be aware of the new MDR regulation that applies. [5] However, devices with AIMDD/MDD certificates will in general remain valid until expiry date, allowing some products to be placed on the market until 26 May 2024, and made available until 26 May 2025. [6]

Researchers, manufactures and others involved in research and development of medical devices should study the new MDR regulation closely in order to make the transition most efficiently in order to comply with the new regulations as well as eventual procedural changes in some countries. [7]

As the approval process is in general demanding and with many requirements it is recommended to prepare and start the application process well in advance.

 

Peter Skov Jensen, MD, PhD
Aarhus, Denmark, 18 June 2021

[1] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG&toc=OJ:L:2020:130:TOC

[2] https://laegemiddelstyrelsen.dk/en/devices/

[3] https://ec.europa.eu/health/md_sector/current_directives_en

[4] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01998L0079-20120111

[5] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01993L0042-20071011

[6] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01990L0385-20071011

[7] https://ec.europa.eu/health/md_sector/new_regulations_en

[8] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424

[9] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20170505

[10]https://ec.europa.eu/health/md_newregulations/overview_da

[11] https://ec.europa.eu/health/md_newregulations/overview_en

[12] https://www.camd-europe.eu/mdr-ivdr-implementation/

[13] https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

[14] https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_manufacturers_factsheet_en.pdf

[15] https://www.dvmk.dk/