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17. 4. 2020
On 17 April 2020, in response to the extraordinary circumstances triggered by the pandemic outbreak of COVID-19 caused by the SARS-CoV-2 virus, the European Parliament approved an amendment to Regulation (EU) 2017/745 on medical devices (MDR). The key aim of the proposed amendment is, in particular, to ensure the availability of medical devices on the market, including the devices critical for combatting COVID-19 and thus alleviate the current burden placed on competent authorities of the Member States, health care providers and other economic operators. The effective date of the MDR has been deferred to prevent putting at risk the due and timely implementation of the requirements laid down by MDR and smooth functioning of the internal market.
The amended of the MDR will introduce the following key changes:
- The effective date of the MDR will be deferred by one year, i.e. the regulation will not come into effect on 26 May 2020 as originally planned but instead on 26 May 2021;
- In the interest of public health or the health and safety of patients, the competent authorities will be allowed to approve the placing on the market or putting into service of a specific medical device that fails to comply with the conformity assessment procedures in accordance with the currently applicable directives on medical devices (93/42/EEC) and implantable medical devices (90/385/EEC) in their territory;
- The European Commission will be allowed to apply the exception granted by a Member State based on the previous point throughout the EU.
Until now the European Commission has not published any information on whether the effective date of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) will be postponed too. The IVDR is therefore still expected to come into effect on 26 May 2022.
Clearly, the deferred effective date of the MDR will also have an impact on the new bills on medical devices currently debated in the Chamber of Deputies (document of the Chamber no. 696) and the draft amendment to the existing act on medical devices (document of the Chamber no. 697). Currently, none of the bills have been passed in the Chamber of Deputies for debate. Given the current development of EU legislation, however, the pressure on their speedy adoption is expected to loosen. That would imply that the introduction of new rules governing the advertising of medical devices (which are part of the above legislative package) will be postponed too.