18.06.2020
Newsletter
MDR/IVDR – what’s new?
Preparations are continuing for the application of the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). However, the COVID-19 pandemic has caused significant challenges in all areas of life, including work for the implementation of the MDR. In light of these challenges, we consider it important to update you on the latest news and recent developments.
In this issue:
- Postponement of MDR date of application
- Commission guidelines on Union-wide derogations for medical devices
- Amendment to Implementing Regulation (EU) 920/2013 on the designation of Notified Bodies
- Commission guidelines on testing for COVID-19 and working document on performance of COVID-19 test methods and devices and performance criteria
- MDCG Guidance on regulatory requirements for ventilators and related accessories
- How to assess whether medical devices and personal protective equipment (PPE) can be lawfully placed on the market
- New lists of harmonised standards made available for medical devices
- A number of European standards for medical supplies made freely available to facilitate an increase of production
- Standardisation request in support of the new Regulations on medical devices
- Commission recommendation on conformity assessment and market surveillance procedures
- A large
number of other guidance documents, working documents and Q&As (remote audits of notified bodies, re-designation of notified bodies, performance of COVID-19 tests…)
MDR date of application postponed
The date of application of the Medical Devices Regulation has been postponed until 26 May 2021.
In the interests of patient health and safety, on 23 April this year the European Parliament and the Council adopted a Regulation amending the Medical Devices Regulation regarding the application dates of some of its provisions.
The Regulation, which entered into force on 24 April, postpones by one year the date of application of most of the provisions in the MDR. This postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors allowing them to focus fully on the fight against the COVID-19 pandemic and the associated public health crisis.
The date of application for the In Vitro Diagnostic Medical Devices Regulation remains unchanged – 26 May 2022.
For more information, click here.
Commission Guidelines on Union-wide derogations for medical devices
On 19 May 2020, the Commission published Guidelines on the adoption of Union-wide derogations for medical devices. The related provision in the MDR is applicable from 24 April 2020. These derogations should be regarded as a measure of last resort, only to be considered by the Commission in exceptional cases to ensure patient health or safety or to protect public health.
The Guidelines provide information on the adoption of these derogations, in particular the criteria that the Commission will take into account to determine whether the extension to the territory of the Union of a national derogation is necessary and justified for a medical device.
The document also provides information on the adoption process, including the role of Member States, and the general conditions that the Commission should set for Union-wide derogations by means of implementing acts.
For more information, click here.
Commission amends rules on the designation of Notified Bodies
The European Commission has amended its rules on the designation and surveillance of Notified Bodies for medical devices with the publication, on 19 May 2020, of Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013.
The amendment is a direct consequence of the MDR postponement and introduces changes to the rules on the renewal of designations and on the surveillance and monitoring of notified bodies under the Medical Devices Directive and the Active Implantable Medical Devices Directive.
The amended rules enable Member States to ensure that currently designated Notified Bodies under the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) can continue to operate during the additional year until the MDR becomes applicable. Moreover, they allow for alternative surveillance and monitoring activities related to Notified Bodies that remain possible under current restrictions resulting from COVID-19.
For the text of the amending Implementing Regulation, click here.
Commission issues guidelines on COVID-19 testing
As part of the European Roadmap towards lifting COVID-19 containment measures, the European Commission has issued guidelines on COVID-19 testing methodologies.
The Guidelines aim to support Member States in effectively using testing tools in the context of their national strategies and during the different stages of the pandemic, including when phasing out confinement measures. The Commission also aims to ensure that high-quality tools are available to assess the performance of the tests.
For more information, click here.
MDCG Guidance on regulatory requirements for ventilators and related accessories
In the context of the current COVID-19 pandemic, which causes severe respiratory symptoms frequently requiring treatment with mechanical ventilators, the Medical Device Coordination Group (MDCG) has issued a Guidance document focusing on ventilators and related accessories that are currently regulated under the MDD.
According to the MDD, devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive and when duly supplied and properly installed, maintained and used in accordance with their intended purpose.
In the current COVID-19 context, the demand for ventilators and related accessories has rapidly increased. Therefore, the Guidance document outlines the different regulatory options for placing these devices on the EU market, indicating their feasibility for short-term supply.
To read the Guidance document, click here.
Assessing whether medical devices and personal protective equipment (PPE) can be lawfully placed on the market
In the context of the COVID-19 pandemic, demand for PPE has skyrocketed. This has resulted in the involvement of economic operators and other interested parties not previously in the supply and verification chain of these products. In addition, recent experience indicates the need to be attentive to misleading or falsified documents as well as to counterfeit products.
To provide more clarity, the European Commission has issued a guidance document that sets out basic indications to allow interested parties to identify whether a product is lawfully placed on the EU market and can continue to be purchased and used.
To read the Guidance document, click here.
New harmonised standards for medical devices
On 25 March 2020, the European Commission published in the Official Journal of the European Union new lists of references to harmonised standards for medical devices under the current Directives (MDD, AIMDD and IVDMDD). A harmonised standard is a European standard developed by recognised European standardisation organisations in the field of medical devices: the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). It is created following a request from the European Commission to one or both of these organisations. Manufacturers, other economic operators, and conformity assessment bodies can use these harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation.
To read the new lists, click here.
Medical supplies standards made freely available to help increase production
In the context of the COVID-19 pandemic, the Commission is working with industry and Member States to maximise the availability of masks, gloves, gowns and other medical supplies. Efforts include increasing production by existing manufacturers, facilitating imports and activating alternative ways of producing equipment.
Upon the urgent request of the Commission, CEN and CENELEC, in collaboration with all their members, have agreed to immediately make available a number of European standards for certain medical devices and personal protective equipment. This action will help both EU and third-country based companies willing to manufacture these items or to reconvert their production lines to swiftly start production and place products on the internal market more easily, while at the same time ensuring a high degree of safety.
Read more here.
Standardisation Request in support of the new Regulations on medical devices
The Commission, on 15 May 2020, adopted an Implementing Decision for a Standardisation Request addressed to the relevant European standardisation organisations (CEN and CENELEC), to develop harmonised standards in support of the MDR and the IVDR.
The Standardisation Request is the necessary legal basis to publish references to harmonised standards in the Official Journal of the European Union, to be used by manufacturers and other economic operators to obtain presumption of conformity of their products with the legal requirements.
For more information, click here.
Commission adopts Recommendation on conformity assessment, market surveillance within the COVID-19 context
The European Commission has adopted Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures to ensure the availability of PPE and medical devices for adequate protection during the COVID-19 outbreak. Furthermore, it has invited all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities, to deploy all the measures at their disposal to support efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market meets the continuously increasing demand.
These measures should, however, not have a detrimental effect on the overall level of health and safety and all relevant stakeholders should ensure that any PPE or medical devices, which are being placed on the EU market, continue to provide an adequate level of protection of users’ health and safety.
For more information, click here.
Stay tuned for future updates!
Information on Medical Devices is set to migrate from the DG GROW website, where it is currently hosted, to the website of DG SANTE.
What’s more, there are new factsheets and other resources in the pipeline, to help you prepare for the application of the MDR and IVDR.
We will keep you informed about these and other important developments, so stay tuned!
In the meantime, make sure to check the Medical Devices section on the Commission website for updates.
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