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Medical devices have always been highly regulated, and the industry is today challenged in two ways; the increasing complexity of compliance and the need for more sustainable materials and production methods.

As these challenges become a more urgent part of the competition in the industry, knowledge and dedicated facilities play a more significant role.

"For instance, the MDR sets a number of unified, new regulations for materials used in healthcare products. This adds a load of regulative and administrative burdens to the industry. Especially the coming procedure of re-evaluating all medical devices which contain resins with phthalates every third year, after 2024 could be stress for the industry," says Daniel Kulwas, International Business Development Manager at Primo.

At Primo we are supporting our customers to comply with the MDR EU regulation 2017/745:

• Especially on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic or have endocrine-disrupting
• In our medical tubes production, we ensure chemical, physical, and biological properties
• Our products are designed and manufactured in such a way as to minimize and eliminate any risks described in the MDR as much as possible
• We continue our research about non-PVC material for medical tubing production

We will provide you with necessary MDR requirements according to the following:

• Technical documentation
• And other designs and manufacturing information, benefit-risk analysis, risk management
• Product verification and validation

Visit Primo Medico at booth R11 in hall 8A.