Delayed implementation of the EU Regulation on Medical Devices

COVID-19 pandemic has endangered the lives and safety of people around the world. Taking into account the problems all of us had to face during the pandemic outburst and the need to focus on the activities in the state of emergency, on 23 April 2020 European Council and European Commission Parliament adopted the Regulation which delays the implementation of the majority of the provisions of the Regulation on medical devices for a period of one year, i.e. for May 2021. The date of the implementation of the EU Regulation on in vitro diagnostic medical devices (EU 2017/746), remains unchanged.

On that occasion, European Commission published a document containing many useful information on better comprehending the EU legal framework, as well as the information on medical devices from the aspect of COVID-19 pandemic. This document is provided below:

Medical devices make an essential contribution to healthcare in the EU for the benefit of European citizens. From sticking plasters to X-ray scanners, dentures to hip joints and in-vitro diagnostic devices that monitor diabetes or identify infections; medical devices are crucial in diagnosing, preventing, monitoring and treating illness, and overcoming disabilities. They are also important to the economy, providing €110 billion in sales and 675,000 jobs in Europe. The EU is a net exporter in this sector.

Date of application of the Medical Devices Regulation postponed until May 2021

With patient health and safety as a guiding principle, the Council and the Parliament adopted Regulation 2020/561 amending Regulation (EU) 2017/745 on medical devices regarding application dates of certain of its provisions on 23 April. This Regulation enters into force on the day of its publication in the Official Journal of the European Union and postpones the date of application for most MDR 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 In Vitro Diagnostic Medical Devices Regulation's (IVDR, Regulation (EU) 2017/746) corresponding date of application remains the same (May 2022).

Highlights

• Commission guidelines on Union-wide derogations for medical devices

• Amendment to Implementing Regulation 920/2013 on the designation of notified bodies

• Call for applications: observers for the EUDAMED sub-group of the medical device coordination group

• Regulatory requirements for ventilators and related accessories

• Working document: Performance of COVID-19 test methods and devices and proposed performance criteria

• Coronavirus: Commission issues guidelines on testing

• Guidance: Active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context

• Coronavirus: Commission issues guidance to increase production of safe medical supplies

• New lists of harmonised standards for medical devices available

• Coronavirus: European standards for medical supplies made freely available to facilitate increase of production

• Call for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)

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European legislation ensures the safety and efficacy of medical devices and facilitates patients’ access to devices in the European market. To keep up with advances in science and technology, 2 new European regulations are replacing 3 existing directives in the years up to 2022.
Whether you are a manufacturer, an authorised representative, an importer, a distributor, a user or a health professional, this website will tell you what you need to know about the new regulations and how they will enhance the quality of medical devices on the European market for the benefit of all.

About medical devices

Regulatory framework
The 2 regulations establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. This, in turn, will boost confidence in our medical devices industry.
Current Directives on medical devices

Medical devices within the EU are currently regulated by 3 directives:

• Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)

• Council Directive 93/42/EEC on Medical Devices (MDD) (1993)

• Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)

New Regulations on medical devices

On 5 April 2017, 2 new regulationson medical devices and in vitro diagnostic medical devices were adopted. They entered into force on 25 May 2017 and will progressively replace the existing directives. The new regulations will be fully applicable in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
The Commission welcomes the adoption of these 2 regulations, which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. This in turn will boost confidence in our medical devices industry.