16/10/2020

Hard Brexit and medical devices, what happens from January 1, 2021

After a slowdown due to the Covid emergency, work is now intensifying in the EU to prepare for January 1, 2021, the end date of the transitional period. From that moment on, UK will formally be a third country (just like the USA, Russia, China, India, etc.) and European law will no longer apply on its territory, with direct consequences for EU companies that market in UK and, vice versa, for UK companies that intend to operate in Europe.
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27/07/2020

Transferring data outside the EU: the Court of Justice sets new boundaries (and why it matters for the medical devices sector)

The MDR (Medical Devices Regulation) needs data. It needs them for clinical evaluations (defined as a "systematic and planned process to continuously generate, collect, analyse and assess the clinical data" in art. 2 n. 44), for clinical evidence (to be proven through data and clinical evaluation, art. 2 n. 51) for post-market surveillance (which consists in "actively and systematically gathering, recording and analysing relevant data", art. 83 par.2).
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29/10/2019

3D-printed medical devices and data protection obligations

As with any medical technology that processes patients' personal data, the use of 3D printing for the manufacturing of medical devices entails an obligation to protect the data and privacy of the individual using the device.
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14/05/2019

A new corporate warranty role: the person responsible for compliance

SILVIA STEFANELLI, ALICE RAVIZZA
The Article 15 of the Mdr introduces an important innovation: the obligation to appoint a person within the MD company who is responsible for compliance with the regulations (so-called Responsible Person or PR). The rule provides for this obligation on the part of the manufacturer (including micro/small enterprises) and also on the part of the authorized representative. 
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13/02/2019

Medical devices, data protection, and cybercrime: the three challenges of new software

Software embedded in medical devices or stand-alone software qualified as MDs are among the products that, more than others, will be affected by the new MDR. Not only many software that are currently not classified as medical devices will fall under the scope of the new Regulation, but the risk class of many software that are already MDs will increase.
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06/02/2019

Apps and telemedicine in view of the new MDR

In this article published by Sergio Pillon (coordinator of the Joint Technical Commission of the Italian Ministry of Health for the development of national telemedicine) on the development of digital healthcare in Italy, the Israeli organization of healthcare is taken as an example, and it is stated that "digital healthcare is the backbone of the system, that is focused, from the patient's point of view, on services offered through apps and supported by Big Data and the network".
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05/02/2019

Timelines and validity of certificates in the light of the new Medical Devices Regulation

What is the validity of certificates issued by Notified Bodies and how long can the related MDs be marketed? What are the rules of the transitional period? The companies in the medical devices sector have many questions concerning the implementation of the new Regulation on medical devices.

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29/01/2019

What changes in the classification of medical devices with the new EU Reg. 2017/745 (MDR)?

One of the first activities that the manufacturer has to carry out is to decide whether, in the light of the new MDR, a product falls within the definition of a medical device and, if so, whether the risk class of the medical device has changed.

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11/12/2018

Is it admissible to display eyeglasses prices in optical store windows in Italy?

Healthcare advertising is a complex field, where it is necessary to mediate between the effective promotion of a product and a correct and appropriate communication, in accordance with the existing legal framework.

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19/11/2018

Person responsible for regulatory compliance

Alice Ravizza

The 745/2017 Regulation on Medical Devices introduces the figure of the Person Responsible (PR), with the aim of giving this figure greater authority and importance to the Responsible / Regulatory Officer within the medical device company organization.

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