Ballerup, Denmark and Redwood City, CA, USA – February 14, 2023 – Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, is pleased to announce that it has received EU MDR certification, well ahead of the May 2024 deadline for medical device companies to comply.
The EU regulation 2017/745 on medical devices, or EU MDR, is a major update to medical device regulations introduced in 2017. The MDR replaces the previous EU Medical Device Directive (MDD), and is designed to modernize the EU regulatory system to better address the current needs of the market and new technologies.
The main objective of the new regulation is to strengthen protection against risks posed by medical devices and to update regulations to properly account for new technologies. Major themes of the new MDR include:
- Expanded focus on regulating the entire lifecycle of a medical device
- Greater emphasis on clinical data
- Increased oversight of notified bodies
“Norlase upholds the highest regard for design, manufacturing, commercialization, and customer care in every major marketplace worldwide,” said Jan Forstberg, VP of Regulatory Affairs and Quality Assurance. “MDR certification is an important milestone that demonstrates our commitment to compliance to even the most stringent of standards.”
The updated regulations have significantly raised the bar for companies commercializing medical devices in the EEA (European Economic Area) and Norlase is proud to diligently and rapidly keep pace with industry and regulatory requirements for innovation and safety. Norlase looks forward to serving more customers, both in Europe and around the world. It continues to expand its partnership with premier distribution partners in key international markets.
To learn more about Norlase, please visit www.norlase.com and follow Norlase on LinkedIn, Facebook, Instagram, and Twitter for updates.
About Norlase
Norlase develops next-generation laser solutions for the treatment of retina and glaucoma diseases. Founded in Denmark, Norlase is made up of worldwide industry experts in ophthalmology, laser technology, medical device development, and customer care. Norlase is on a mission to improve practice efficiency, patient care, and physician convenience for
ophthalmologists worldwide. Norlase products include LEAF, a laser photocoagulator that’s 10x smaller than existing systems and mounts directly on the slit lamp; LION, the first fully integrated green laser and LIO; and ECHO, the world’s first ultra-portable pattern scanning laser. Learn more at norlase.com.
Norlase Media Contact
Levi Hall
LG Marketing+
levi@lgmarketing.me
The EU regulation 2017/745 on medical devices, or EU MDR, is a major update to medical device regulations introduced in 2017. The MDR replaces the previous EU Medical Device Directive (MDD), and is designed to modernize the EU regulatory system to better address the current needs of the market and new technologies.
The main objective of the new regulation is to strengthen protection against risks posed by medical devices and to update regulations to properly account for new technologies. Major themes of the new MDR include:
- Expanded focus on regulating the entire lifecycle of a medical device
- Greater emphasis on clinical data
- Increased oversight of notified bodies
“Norlase upholds the highest regard for design, manufacturing, commercialization, and customer care in every major marketplace worldwide,” said Jan Forstberg, VP of Regulatory Affairs and Quality Assurance. “MDR certification is an important milestone that demonstrates our commitment to compliance to even the most stringent of standards.”
The updated regulations have significantly raised the bar for companies commercializing medical devices in the EEA (European Economic Area) and Norlase is proud to diligently and rapidly keep pace with industry and regulatory requirements for innovation and safety. Norlase looks forward to serving more customers, both in Europe and around the world. It continues to expand its partnership with premier distribution partners in key international markets.
To learn more about Norlase, please visit www.norlase.com and follow Norlase on LinkedIn, Facebook, Instagram, and Twitter for updates.
About Norlase
Norlase develops next-generation laser solutions for the treatment of retina and glaucoma diseases. Founded in Denmark, Norlase is made up of worldwide industry experts in ophthalmology, laser technology, medical device development, and customer care. Norlase is on a mission to improve practice efficiency, patient care, and physician convenience for
ophthalmologists worldwide. Norlase products include LEAF, a laser photocoagulator that’s 10x smaller than existing systems and mounts directly on the slit lamp; LION, the first fully integrated green laser and LIO; and ECHO, the world’s first ultra-portable pattern scanning laser. Learn more at norlase.com.
Norlase Media Contact
Levi Hall
LG Marketing+
levi@lgmarketing.me
DIDN’T FIND WHAT YOU’RE LOOKING FOR?
Let us know how we can help!
DIDN’T FIND WHAT YOU
WERE LOOKING FOR?
Let us know how we can help!
