Monthly Archives: June 2019

EU Commission Factsheet on MDR and IVDR

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Still confused about the regulatory changes affecting medical devices and in vitro devices? The EU Commission has published a useful factsheet, which you can find here.

Through the factsheet, the Commission warns health institutions and healthcare professionals that the upcoming changes may have consequences on the availability of medical devices because manufacturers may decide to stop their production or because products may not get their certificates on time.

Some notified bodies have also decided to drop off and only two notified bodies have been MDR designated so far, so this will create additional bottlenecks. A short grace period until 2025 is granted, but it does not apply to class I devices.

The path to an enhanced regulatory framework will be complicated and manufacturers, healthcare institutions and healthcare professionals need to know what to expect.

Clinical Trial Regulation: Another Piece of the Puzzle

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Another piece of the puzzle that will become the Italian clinical trials regulatory framework has been completed last week through the publication of Legislative Decree no. 52 of 2019. We had already talked about changes to clinical trials legislation in this previous post and some of the current changes had already been foreseen in such bill.

Here are the major changes:

  • The Italian pharmaceutical agency (AIFA) will be called to issue requirements for trial centers and specific weight will be given to the involvement of patients’ associations by the center in the protocol definition;
  • Patients associations will be involved also in the process of evaluation and authorization of clinical trials;
  • AIFA will publish data on authorized trial centers, along with curricula vitae of individuals involved in the conduct of the study;
  • AIFA will also need to set forth rules to guarantee the independence of the clinical trials and the absence of conflicts of interest in furtherance of section 9 of EU Regulation 536/2014;
  • In case of breach of terms and procedures relating to clinical trials, or of rules on independence and transparency, an ethical committee may be suspended;
  • New rules aimed at facilitating non-profit trials and observational studies (also post-market) will be introduced, which will allow the assignment of study data and their use for registration purposes.
  • Research methodologies and clinical trials conduct will be the subject matter of specific training courses offered, also as continuing medical education.

In conclusion, we need to wait for further rules before the puzzle is complete.

New Rules on Public Procurement

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On June 12, following a confidence vote, the lower chamber of the Italian Parliament has approved a law that will bring quite a few changes to the Public Procurement Code.

The new law, which has not been published in the Italian Official Gazette yet, has been enthusiastically announced as a way to accelerate governmental contracts, in line with the nickname of the act (“Sblocca Cantieri“, which could be translated as “Unlocking Building Sites”).

By way of example, the act allows subcontracting up to 40% (the previous threshold was 30%) and sets forth that only three competing offers will be required for contracts with a value between 40 and 150 thousand Euros. It also includes rather odd provisions, such as the increase in spending for close circuit tv cameras in public structures’ premises where small children and old people are cared for (see section 5 septies). 

The law has been bitterly criticized by the head of the Italian Anti-Corruption Authority, who pointed out that the aggregate value of public procurement contracts is at its highest (139.5 billions in 2018) and that criminal infiltration in companies bidding for public works is also very significant. Many fear that de-regulation of the sector will not bring positive results.

Others simply point out that this body of law has been subject to too many changes in the past years, which makes it difficult for helpful case law to develop and confuses operators.