MDR (Medical Device Regulation) Compliance at Irema Ireland
Irema Ireland is a byword for quality and compliance in the manufacture of medical face masks for numerous OEM clients and under the Facemate brand for over 35 years. Under the watchful eye of our experienced Quality Control & Regulatory Affairs department, our industry leading Surgical and Respirator Face Masks are manufactured in our Limerick facility, to be fully compliant with the new MDR (Medical Devices Regulation (2017/745/EU)) in advance of its coming into effect in May 2020.
The new regulation, known as ‘the MDR’, brings EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulation creates a robust, transparent, and sustainable regulatory framework across the EU, which improves clinical safety and creates fair market access for manufacturers.
Speaking on the introduction of the new MDR, Andrew Dawson, Quality & Regulatory Affairs Manager explained, “Irema Ireland has a long history of technical and procedural excellence in the field of regulatory compliance and this new regulation brings us the opportunity to again come to market with a demonstrably safe and effective product ensuring protection for customers and clinicians everywhere.”
Irema Ireland’s range of Respirator Face Masks is available in both FFP2 and FFP3 classifications. The Surgical Face Masks all reach a Bacterial Filtration Efficiency greater than 98% and come in standard and speciality formats all of which comply fully to the incoming MDR. Irema Ireland offers full OEM, private labelling and ‘Facemate’ distribution opportunities for our medicate al mask product range.