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Should medical device manufacturers be frightened by significant changes?

In the coming years, medical device manufacturers can expect significant changes! What are those changes about and how to address the upcoming challenges? You can find out in this article!

Manufacturers of medical devices have long been governed by the same regulations for entering the EU market but this is all about to change. Starting in 2017 the EU has been introducing changes to the Medical Device Directive and the Directive on active implantable medical devices. These changes are finally about to come into force now.

Both medical device manufacturers and the Notified Bodies who take part in the process of approving the “registration” of these medical devices will be heavily regulated under the new legislations.

So what exactly do those changes entail?
The newly introduced changes to the Medical device regulations concern:

  • clinical evaluation,
  • classification,
  • clinical evidence,
  • post-market oversight,
  • specifications,
  • product scope expansion,
  • identification of qualified persons and
  • Implementation and identification of medical devices in the EU.

Clinical evaluation of medical devices from classes 2a and 2b will need to be reconsidered bearing in mind the new content of the regulations. Depending on the invasiveness, risk and contact duration many medical devices will have to be reclassified, this should be done considering that the requirements for class 3 and implantable devices will be higher under the new MD legislation. These devices will also require more clinical evidence including medical studies being conducted post-market as part of the continuous risk assessment of the products.

The Notified Body will be held responsible for conducting the so-called post-market risk assessment, which will consist of the following:

  • product testing,
  • sample checks,
  • unannounced audits.

On many accounts, the Notified Bodies will also have to prepare yearly reports to account for the safety and performance of the medical devices. Products such as cosmetic implants and colored contact lenses, which are not intended for medical purposes, will also be affected by the new regulations. A single individual from each medical device manufacturing organization will be held responsible for the implementation of the new regulations. This person must have proof of relevant competence related to this responsibility. Another new regulation that will be implemented is the necessity of a UDI or unique device identification number that is needed to ensure the possibility of tracking the medical devices throughout their journey to the consumer.

The new Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745) and will be effective on 26 May 2021. One of the effects of the implementation of the new regulations will be that manufacturers and healthcare professionals will be provided a fairer market entry opportunity.

There is a condition applied by article 120 that states that devices previously accredited under the existing MDD before 26th May 2021 can be brought to the market till May 2024. This is done so that patients in need of a certain device are not limited in their ability to provide it for themselves. The condition is that no significant changes can be made to any medical device. A significant change may be considered any change made to the design or intended purpose of the medical device and if the change qualifies or not for a significant one must be assessed by the Notified Body.

Although clear guidelines to what constitutes a significant change are not provided, assessing if a change is significant or not is of great importance. Therefore seeking legal consultation is advisable. We, at Chameleon Pharma Consulting, are always ready to provide your company with the necessary support and guidelines!