SGH Medical Pharma secures CE mark renewal for medical devices

SGH Medical Pharma successfully renews CE marking certificates for its Stiplastics and Rovipharm medical devices under MDR 2017/745 – 5 years ahead of the deadline!

Great news! We have renewed our CE marking certificates for our medical devices under the latest MDR 2017/745 regulation.

Milestone in medical device compliance

SGH Medical Pharma is pleased to announce it has successfully obtained CE marking certificates under the new Medical Device Regulation (MDR) 2017/745. This achievement covers medical devices produced at our Stiplastics and Rovipharm sites. This regulation aims to ensure the smooth functioning of the internal market regarding medical devices.

Specific product certifications for Rovipharm and Stiplastics

At Stiplastics, dosing spoons, cups, and droppers have earned this vital certification. At Rovipharm, pipettes, spoons, beakers, and dosing rulers for medicinal dosages now comply with the EU’s essential quality and safety requirements. CE marking confirms that a medical device has passed a conformity assessment. This certification is mandatory for placing medical devices on the European market.

The future commitment of SGH Medical Pharma

This success reflects the dedication of our R&D, production, quality, and regulatory teams. Their work allowed us to achieve this certification five years ahead of the deadline for historical medical devices. We are committed to maintaining high standards in quality, safety, and innovation. We will continue to invest in research, listen to customer feedback, and work with health authorities.