Pharmalink is one of the first companies to obtain EU-MDR CERTIFICATE 

Medical Devices in EU are currently governed by the Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 2017 on medical devices (Medical Device Regulation, or “MDR”) from May 26th, 2021. New medical devices developments should already be focused at complying with the MDR requirements.

The medical devices’s manufacturers have a transition period until May 26, 2024 to certify all those devices that are currently certified by the previous Directive 93/42/CEE or MDD, called Medical Device Legacy.

Pharmalink obtained at the end of 2020 the first certification under MDR in Europe for cough syrups devices and currently has more than 10 references certified under MDR, being a pioneer company in this regard.

Pharmalink currently has the following categories of medical devices certified under MDR:

In 2020

Medical devices in liquid form for the treatment of cough: a complete range of cough syrups based on cane sugar, gums and natural plant extracts, suitable for adults and children from 1 year.

In 2021

Sprays solution for nasal irrigation: nasal sprays based on sea water and purified water with different salts concentrations, formats and spray strengths, indicated for daily cleaning and nasal decongestion, to cover all the user’s needs from birth.

Very soon, Pharmalink will expand the category of Sprays solution for nasal irrigation obtaining the certification under MDR of:

  • Nasal sprays based on sea water and purified water with natural plant extracts, indicated for nasal decongestion. Plant extracts aid and prolong the moisturizing power of sea water and provide a pleasant and fresh aroma.
  • Nasal sprays based on saline solution with propolis and natural plant extracts, indicated in pathological processes as rhinitis, excessive secretions, flu and catarrhal processes.