SGS Issues Its First Ever Medical Device Regulation (MDR 2017/745) Certificate

We are thrilled to have issued our inaugural Medical Device Regulation certificate to Newclip Technics in record time.

Following a process that involved long hours and great dedication, we are thrilled to have issued our first Medical Device Regulation (MDR 2017/745) certificate to Newclip Technics, a designer, manufacturer and marketer of osteosynthesis implants for elective surgery and traumatology.

The time between contract signing and issuance of certification was just 6 months – a record, as the average time recorded on the market with Notified Bodies (NBs) varies between 12 and 18 months.

SGS Global Medical Devices Certification Manager, Virginie Siloret, said: “Everyone involved was extremely devoted and put in long hours. A big thank you to each of you for this milestone achievement, following our designation last December.

“A huge congratulations to Newclip Technics, which established a solid quality management system and good technical documentation that supports the quality of their devices. We wish them all the best for the future.”

This represents a new era for Newclip Technics, which received its documentation following a thorough SGS audit.

Newclip Technics Group Executive Director, Frédéric Serre, added: “Reaching EU MDR certification level is a major step for us. It ensures the continuous availability of all our products at hospitals for the benefit of patients.

“A big thank you to SGS for their commitment and support during the certification process.”

Designation and why SGS?

In May 2021, MDR officially replaced the Medical Device Directive (MDD) to enhance safety for European patients through a more robust and transparent framework. This change also brings medical device regulations into line with technical advances, changes in medical science and progress in law-making. 

Our Belgian NB was designated a European MDR NB by the European Commission and Belgian Competent Authority (FAMHP) under MDR (EU) 2017/745 in December 2021.

With existing approval under the UK Conformity Assessed (UKCA) scheme, we are one of the few companies that can provide certification services for medical devices across the whole of Europe. 

More information on our medical devices services.

To start your MDR CE certification process, fill out our questionnaire.

For further information, please contact:

Virginie Siloret
Global Medical Devices Certification Managerr
Knowledge
t: +41 22 739 98 58