As we informed you earlier in our article, new EU legislation fundamentally regulating the field of medical devices was to enter into force on 26 May 2020, namely Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter referred to as the “MDR”).
Generally
Given that the exceptional circumstances arising from the COVID-19 pandemic have a significant impact on the various areas that should be covered by the MDR´s and that Member States, healthcare facilities, economic operators and other relevant parties are therefore unable to ensure proper implementation and application of the mentioned regulation as early as 26 May 2020, as provided for in its original wording, the European Union postponed the application of certain provisions of the MDR for one year when the Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices was adopted as regards the dates of application of certain of its provisions. From the above postponement, a functioning regulatory framework for medical devices will still be in place from 26 May 2020.
At the same time, in relation to the postponed application of MDR, the date of cancellation of Directives 90/385/EEC (“AIMDD”) and 93/42/EEC (“MDD”) was also postponed.
Furthermore, in this article we would like to draw attention to some selected changes that the postponement of the MDR regulation currently brings.
Derogation from conformity assessment procedures
One of the first substantial changes is the amendment to Article 59 of the MDR, which regulates the derogation from conformity assessment procedures and newly provides that ‘any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in those Articles have not been carried out but use of which is in the interest of public health or patient safety or health,’ whereas this exemption also applies for the period from the date of entry into force of the MDR until 25 May 2021, i.e. even before the rest of the MDR becomes applicable. Such applications should then be assessed and decided on by SÚKL in the Czech circumstances.
The cited provision is intended to react on the current situation regarding the COVID-19 pandemic in order to provide the necessary medical devices on the market.
What happens to medical devices placed on the market before the date of application of the MDR?
It is still the case that medical devices placed on the market after the date of application of the MDR must already comply with the MDR and meet all its essentials and requirements with the previously already mentioned rules and exceptions.
As for the individual deadlines, they are being adjusted or postponed, in accordance with the amended transitional provisions of the MDR, in principle by exactly one year.
The provision of Article 120 paragraph 4) of the MDR for example provides that ‘devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.’
Sanctions
As regards the sanctions imposed for breaches of the provisions of the MDR, the provision remains the same, i.e. it is left to Member States to determine the penalties and to take all measures necessary to ensure their implementation, whereas the penalties provided for shall be effective, proportionate and dissuasive.
Only the deadline, by which Member States must notify the Commission of the sanctions and measures provided for, which is postponed by one year, i.e. until 25 February 2021, changes.
And what about IVDR?
The changes described above do not affect Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Currently, it is still valid that the IVDR should be applicable from 26 May 2022.
Conclusion
The above described amendment to the MDR and the postponement of its application by one year should enable the Member States to better prepare for any necessary implementation steps that need to be taken in connection with the adoption of the new legislation, thus giving them additional time.
At the same time, however, in the current situation it is not possible to have exaggerated expectations that Member States will always have sufficient capacity to deal with the issues related to the adoption of the new MDR regulation, when, for example, as far as the Czech Republic is concerned, the discussion of laws that were to be adopted in connection with the MDR[1][2] has been postponed so far.
However, the postponement of the application of the MDR as such can be assessed positively and as an appropriate step, especially distributors and manufacturers will certainly appreciate the postponement of the MDR, as it gives them additional time to prepare for the new legislation.
If you have any questions about medical devices in the light of new and existing legislation, please contact us.
Mgr. Bc. Štěpánka Vajdová, junior lawyer – vajdova@plegal.cz
Mgr. Jakub Málek, partner – malek@plegal.cz
26. 05. 2020
[1] Amendment to the Medical Devices Act, Parliamentary Press 697/0, Part No. 1/6
(https://www.psp.cz/sqw/text/tiskt.sqw?O=8&CT=697&CT1=0)
[2] Government bill on medical devices, Parliamentary Press 696/0, Part No. 1/6 (https://www.psp.cz/sqw/text/tiskt.sqw?O=8&CT=696&CT1=0)