SGS Notified Body (NB) 1639 is celebrating two milestones – the second anniversary of becoming an EU Medical Device Regulation (MDR) NB and concluding its first MDR Article 117 assessment.
A time for reflection and further evolution
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.
Virginie Siloret, SGS Global Medical Devices Certification Manager, said: “The team worked very hard to become designated, so it’s been a great two years delivering MDR certification for a whole range of devices, from Class I to III active, non-active, implantable and accessories.
“Our team works rigorously every day to ensure our services are the best they can be. We constantly explore how we can improve the compliance and efficiency of our processes.
“As it is the second anniversary and the end of the year, we thought it the perfect opportunity to celebrate, reflect and have our latest meeting on service refinement.
“We came away with several exciting initiatives to make things more efficient, and we look forward to rolling these out in 2024.”
SGS NB 1639 is ready to help new and existing customers achieve the best results as fast as possible. The team’s experience keeps growing, already assessing over 100 devices and integrating more than 40 people in 2023.
Finishing its first Article 117 assessment
Following months of determination, the team presented its inaugural Article 117 certification.
Milad Masjedi, SGS Global Medical Device Technical Manager, added: “Our team is overjoyed to conclude its first-ever Article 117 assessment process.
“We worked determinedly to ensure an efficient process and learned many takeaways to improve this service even further.”
What is an Article 117 assessment?
To gain EU market access, pharmaceutical companies’ drug-device combination medical products must meet MDR Article 117 requirements.
We can assess and certify the compliance of drug-device medical products, including:
- Pre-filled syringes
- Pre-filled pens
- Nebulizers pre-charged with a specific medicinal product
- Patches for transdermal drug delivery
- Pre-filled inhalers
Our experts also have the experience and capacity to assess medical devices containing medicinal substances according to MDR Rule 14.
Why choose SGS Article 117 assessments?
Our ever-evolving service can help you:
- Ensure that your drug-device combination medical product meets Article 117 requirements
- Confirm that your device complies with the relevant General Safety and Performance Requirements (GSPR)
- Gain a conformity assessment statement for inclusion in the Market Authorization Application (MAA)
With existing approval under the UK Conformity Assessed (UKCA) scheme, we are one of the few companies that can provide medical device certification services across the whole of Europe.
To discover our portfolio, visit our Medical Devices Regulatory Compliance web page.
For further information, please contact:
Global Medical Devices Certification Manager
t: +41 22 739 98 58
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