What is the MDR ?

(Medical Device Regulation)

The new Medical Device Regulation came into effect on 26 May 2021. Since that date, any manufacturer wishing to place a medical device on the market must comply with this regulation. Products that already had a MDD label certificate can be sold until May 2025, depending on the expiry date of their EC certificate.

What is the purpose of the MDR?

The new regulation is based on three main objectives of the European Government.

  • To improve the level of health and safety.
  • To continue to strengthen the free trade of medical devices within the EU.
  • To ensure that products placed on the market are state of the art.

What are the differences between MDD and MDR ?

EU Directives must be transposed into national law to be applicable, whereas EU regulations are EU law and are directly applicable without transposition. The old medical device directives let place for interpretation, whereas the regulation is much more detailed and therefore clearer, but more restrictive.

Safety and reliability requirements are more stringent, with a focus on the life cycle, supported by clinical data and increased post-market surveillance. Transparency and information to users is also increased.

MDR… Our start-up is taking up the challenge with determination

Lina da Fonseca – CEO Synaxial

Synaxial® is going MDR.
But why do it now ?

The decision was made at Synaxial® to go MDR as soon as possible. Being on the cutting edge has always been part of our company values, it is in our DNA. We were looking to improve our production process and to make this significant change possible, switching to MDR was the right thing to do. So the timing was perfect for us. The hardest part was telling our customers and distributors that our product would be temporarily unavailable on the market.

Why the SinusJet® is temporarily unavailable ?

We would have liked this change to be transparent, but in parallel with the change of certification, we also chose to capitalise on a new, more environmentally friendly cleaning technology. The integration phase of the new process is underway. We want everything to be perfect.

When will the SinusJet® be available again ?

We are a start-up and as you can imagine, we have to be on all fronts simultaneously. But we aim to be back on the market as soon as possible. And we’ll be using this opportunity to make a big announcement. Surprise ! Stay tuned !

Lina da Fonseca
CEO Synaxial®