One month till the new dawn – EU IVDR will be applied in full in May 2022 

In this blog post, our Health Tech Team Leader Tiina Riihimäki provides an overview of the latest developments and the foreseeable challenges in the process. Read her expert advice on how to prepare for this historic legislative change.


DRA Driving Responsible Action

What does responsibility mean to you? What would you set as your goal for social responsibility in 2022? These are some of the questions that all DRA’s employees were asked in the beginning of this year.


Five tips for the reference price jungle

You need to be familiar with the Finnish reference price system in order to submit price notifications appropriately and on schedule. At worst, forgetting to submit price notification may lead to the medicinal product losing its reimbursability.


The Camino de Hope campaign challenges DRA employees to start exercising

The idea of the challenge is to clock up 1,000 kilometres in a year without any help from motors. Many DRA employees took up the challenge, and we were also able to involve our customers.


Assessing the biological safety is a measure that protects both the user and manufacturer of a medical device.

The process for biological hazard identification and risk assessment is called biological safety evaluation. Often this means an evaluation and testing process based on the ISO 10993 standard.


MD/IVD Regulation causes changes to national legislation in EU member states

 A new Finnish national legislation has entered into force.


Sales is undergoing major changes: from personal selling to hybrid selling led by COVID-19

Experiences in successful adaptation of B2B service selling during these exceptional times.


Mode of action defines whether your product is a medicinal product or a medical device

Medicinal products and medical devices alike can be used to diagnose, prevent, treat, and alleviate diseases, or to correct, restore or modify physiological processes.


Do you know which designation codes are applicable to medical devices manufactured by your company?

When a manufacturer applies for conformity assessment from a notified body (NB), the type of devices and technologies subject to conformity assessment activities are to be indicated using designation codes.


Notified Body – A business-critical relationship

Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.


Is your product a medicinal product, a medical device, or both?

Determining which legislation a product falls under is essential. When the question of which legislation applies to a product is not unequivocal, the term borderline products is used.


What is a PRRC and why is it necessary to have one when the new MD Regulation enters into force?

One of the most significant new regulatory provisions is related to the increased requirements for internal monitoring by companies, namely the designation of a Person Responsible for Regulatory Compliance (PRRC).

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