Medical equipment (European market)

Main article: Medical equipment (global market)

Regulation of the medical equipment market

Main article: Regulation of the medical equipment market in Europe

2021: EU allows remote audit of medical equipment

In mid-January 2021, the European Union announced that it would allow remote audit of medical equipment and in vitro diagnostics in accordance with new rules (MDR IVDR), which will enter into force in May 2021 and 2022, respectively.

The European Commission has informed the relevant authorities that the ongoing COVID-19 pandemic makes it very difficult, and sometimes impossible, for businesses to verify personally. Apparently, a remote audit "demonstrates an adequate level of security and does not jeopardize the overall reliability of such assessments," the regulator said.

European Union allows remote audit of medical equipment

The solution itself does not specify how the remote audit will be conducted. This is a temporary measure that will only last until on-site verification is possible again, and the European Commission leaves specific decisions to each of the 27 member States. The competent authorities should develop a procedure for conducting audits in cooperation with the relevant authorities of each country, which can complicate the situation for manufacturers of medical technologies who want to distribute devices in more than one country. The competent authorities should also inform the European Commission of their methods and justify their use. The decision of the European Commission was taken as a long-awaited step towards the auditors.

This important and positive event, - the senior regulation manager and industrial police of MedTech Europe Merlin Rietschel wrote to LinkedIn. - The vast majority of Member States support the need for virtual audit.

The Team-NB Alliance of Notified Bodies also lobbied for the remote audit option, but did not comment on the European Commission's decision.^[1]

2020: Europe has abolished duties and VAT on medical equipment

In early April 2020, the European Commission decided to waive duties and value added taxes (VAT) on a number of medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic .

This measure applies to testing kits, VIA machines and other medical equipment and will be valid for six months. This decision was made by the European Commission against the background of an acute shortage of protective equipment for doctors, as well as equipment extremely necessary for the treatment of patients with COVID-19.

The European Commission decided to waive duties and value added taxes (VAT) on a number of medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic

In this emergency, it is vital to ensure the delivery of medical equipment and devices to regions where they are urgently needed, "said Paolo Gentiloni, Commissioner for Economics, in a press release. - By abolishing customs duties and VAT when importing these funds from outside the EU, the European Commission will help make them more accessible.

Customs and EU tax laws allow such benefits "in favour of victims of natural disasters," but this required special permission from the Commission.

The whole complex of means for combating coronavirus is very expensive. Therefore, we are suspending a number of customs duties on medical equipment and goods that come to the EU from third countries, "said Ursula von der Leyen, head of the European Commission.

She cited Italy as an example, where masks and protective clothing for doctors are subject to 12% import duties, as well as VAT in the amount of another 22%. The Commission hopes that the measures introduced will significantly reduce the costs of national health systems and use the freed funds to help affected people.^[2]

2016: New regulation of the medical equipment market in Europe

Main article: Regulation of the medical equipment market in Europe

At the end of May 2016, European regulators and legislators agreed to settle the medical equipment market. The agreement is aimed at closing regulatory gaps that hinder the development of technologies. More details here.

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