Media kit
On May 26, 2021, the new regulations (EU) 2017/745 and 2017/746 on the placing on the market of medical devices and in vitro diagnostics, will come into force. They aim to improve the safety of equipment manufactured and placed on the European market. They will apply to implantable (non-active), single-use, electro-medical devices, medical and pharmaceutical packaging, and accessories: syringes, dressings, gloves, orthopedic insoles, etc.
"Our mission is to help manufacturers adapt to the complex world of international regulations to facilitate their access to different markets, while guaranteeing a high level of safety for patients and healthcare professionals. SGS has the legitimacy and the tools to carry out the assessment of medical devices and packaging," explains Malika Moukaideche, Sales Manager, Medical Devices, SGS CRS.
New obligations will be imposed on manufacturers/agents, importers and distributors (including pharmacies and supermarkets):
- For notified bodies, better harmonization of practices will be adopted, particularly in terms of skills. For example, staff will be required to have at least four years' professional experience in the field of health products or related activities, including manufacturing, auditing or research, two of which must be in design.
- New procedural obligations will be introduced, for example: unannounced visits to manufacturers, product controls, etc.
- Pre-market assessment will be strengthened, for example with clinical data (Eudamed).
- And to ensure greater transparency and traceability, each device will have to carry a unique identification number (UDI).
Thanks to its accreditations and multi-disciplinary expertise, SGS France is able to support manufacturers in all the complexities generated by these new regulations.
A wide range of expertise
At its laboratory in Aix-en-Provence (13), SGS tests all electrical medical devices, including ultrasound scanners, for which experts measure probe temperature rise, and functional rehabilitation equipment, which is tested for temperature and leakage current. Stability and mechanical resistance tests can also be carried out, and for connected products (insulin pump, electrocardiogram (ECG), perineal rehabilitation probe...) numerous performance tests are possible.
According to the company, SGS is No. 1 in ultrasonic measurements in France.
Working closely with manufacturers' engineering teams, SGS helps them carry out the necessary measurements throughout the equipment development cycle. For ultrasound scanners, for example, we can perform mechanical and thermal index tests.
SGS also specializes in the cybersecurity of electro-medical devices. The aim is to guarantee the security of connected equipment, through software evaluation. In fact, SGS has set up a dedicated team whose mission is to try and hack customers' software to check its vulnerability. Example: hacking a pacemaker by introducing malware.
At our laboratory in Cestas (33), we test medical/pharmaceutical packaging and "non-electrical" devices. Sterile barrier packaging undergoes stability, aging and performance tests (leaks, drops). Experts also characterize the materials used, through mechanical, thickness, permeability and dimensional tests. Transport simulation tests are also possible: climatic, drop, compression and localized impact tests, etc.
Pharmaceutical packaging involves chemical characterization of materials (extractables/releasables, pharmacopoeia testing...according to US regulations...), through to performance testing (permeability, torque measurement, sealing, compression and impact resistance).
Labels are also tested according to manufacturers' validation plans, FINA-defined standards, and current international standards (ISO, EN, NF, DIN, ASTM). For example: all labels must remain legible (marking visible over time).
Single-use devices such as dressings, compresses, prostheses, syringes, gloves, insoles, etc. undergo so-called "fatigue" mechanical tests: torsion, traction, etc.
SGS customers include Lumibird. For 50 years, the company has been designing, manufacturing and distributing high-performance lasers for scientific, industrial and, above all, medical use. SGS France performs electrical safety compliance testing for its subsidiary Quantel Medical, for their ultrasonic and ophthalmic laser equipment to access the European and international markets.
"We've been working with SGS France since 2017. Every year, we entrust them with five to seven pieces of equipment to ensure compliance in electrical safety and essential performance, and enable us to export to our various markets. Their various laboratories benefit from the required accreditations, testing resources and technical expertise, with recognized compliance reports obtained under the best conditions and deadlines. The fact that they are part of a world-leading group also reassures us of their ability to meet international requirements. All our devices comply with these standards, for everyone's safety", explains Bruno Pages, Quality Director of the Lumibird Group.
What about accreditations and standards?
The Aix en Provence laboratory is equipped to carry out tests to EN/IEC 60601-1 and EN/IEC 61010-1 standards on a wide variety of devices. It is accredited as a Certify BodyTesting Laboratory (CBTL) by the IECEE, and is qualified to issue foreign certification marks (NRTL, inmetro, etc.).
For ultrasonic measurements: ISO/IEC 17025, IEC 61689, IEC 60601-2-5, IEC 60601-2-37; IEC 60601-2-62 and IEC 62127-1, IEC 62359.
The Cestas laboratory: transport simulation standards: ASTM D4169, ISO4180, ISTA 1A, ISTA 1G, ISTA 1H, ISTA 2A, ISTA 2B and ISTA 3.
