Is your company ready for the inducement prohibition?

Only a few weeks away: as of 1 January 2018 the inducement prohibition for medical devices will become effective, please see our previous newsletters on this topic here and here.

As a brief recap: inducements that are aimed at stimulating the prescription or supply of medical devices by awarding, offering or promising benefits in cash or in kind to healthcare professionals (HCPs), healthcare institutions, health insurance companies or other persons professionally involved in the application/use of medical devices will be prohibited.

The following forms of inducement will still be allowed if certain conditions are met: (i) compensation for participating in meetings, (ii) fees for services, (iii) gifts of limited value and (iv) discounts and bonuses.

Disclosure of 2017 financial relations (sunshine)

Based on the self-regulatory Code for medical devices (GMH Code) all financial relations between all medical device suppliers and all medical specialists regarding services and sponsoring regarding 2017 must be disclosed in the publicly accessible Dutch Transparency Register. Data on the financial relations will have to be submitted in the beginning of 2018 and disclosure is expected to take place in the spring of 2018. Please see our previous newsletter on this here.

IGJ publishes summary of new medical device regulations 

The Dutch Healthcare and Youth Inspectorate (in formation) (IGJ) published a summary regarding the European Medical Device Regulation (EU) 2017/745 (MDR) and the European In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR). The MDR will apply as of 16 May 2020 and the IVDR will apply as of 26 May 2022 and will replace the current EU medical device directive. The IGJ informs that this new set of regulations is:

  • aimed at strengthening the system of market access by e.g. stricter requirements for notified bodies and clinical evidence;
  • aims for more transparency for patients and better traceability through the European EUDAMED database; and
  • provides for more strict rules for certain products whereby more products will be classified in a higher risk category leading to more strict requirements for such products.

The IGJ summary can be found here (document is in Dutch).