On 26 May 2021, the new regulations (EU) 2017/745 and 2017/746 relating to the marketing of medical devices and in vitro diagnostics will come into force. They aim to improve the safety of equipment manufactured and put on the European market. They will be applied to implantable (non-active), single-use, electro-medical, medical and pharmaceutical packaging, and accessories: syringes, bandages, gloves, orthopedic insoles...
"Our mission is to help manufacturers adapt to the complex world of international regulations to facilitate their access to different markets, while ensuring a high level of safety for patients and healthcare professionals. SGS has the legitimacy and tools to carry out the evaluation of medical devices and packaging," explains Malika Moukaideche, Commercial Manager, Medical Devices, SGS CRS.
New obligations will be imposed on manufacturers/agents, importers and distributors (including pharmacies and large retailers):
- For notified organizations, better harmonization of practices will be adopted, particularly in the area of competency. For example, staff must have at least four years of professional experience in health products or related activities, including manufacturing, auditing or research, including two years in design.
- New procedural requirements will be put in place, for example: unannounced visits to manufacturers, product controls, etc.
- Pre-market evaluation will be strengthened, for example: clinical data (Eudamed).
- And to ensure greater transparency and traceability, each device will have to wear a single identification number (IDU).
With its multidisciplinary accreditations and expertise, SGS France is able to support manufacturers in all the complexities generated by these new regulations.
In its laboratory in Aix-en-Provence (13), SGS tests all electrical medical devices, including ultrasound scanners for which experts perform measurements to warm up the probes, or functional rehabilitation equipment, on which temperatures are tested, current leakage. Stability and mechanical resistance tests can be carried out, and for connected products (insulin pump, electrocardiogram (ECG), perineal rehabilitation probe...) many performance tests are available.
According to the company, SGS is number one on ultrasonic measurements in France.
Working with the manufacturers' engineering teams, SGS helps them take the necessary measurements throughout the equipment development cycle. For example, for ultrasound tests mechanical and thermal index tests can be performed.
Cybersecurity of electro-medical devices is also one of SGS's areas of expertise. The aim is to ensure the security of connected devices, including software evaluation. In fact, SGS has set up a dedicated team whose mission is to try to hack customers' software to verify its vulnerability. Ex: hacking a pacemaker via the introduction of malware.
In his laboratory in Cestas (33), medical/pharmaceutical packaging and "non-electrical" devices are tested. Sterile barrier packaging undergos stability, aging and performance tests (leaks, falls). Experts also characterize the materials used, by mechanical tests, thickness, permeability, or dimensional controls. Transport simulation tests are also possible: climate tests, falls, compression and localized impact, etc.
Pharmaceutical packaging, on the other hand, passes through the chemical characterization of materials (extractables / spreadable, tests according to pharmacopoeia... according to U.S. regulations...), up to performance tests (permeability, torque tightening, sealing, compression and shock resistance).
Labels are also tested according to manufacturers' validation plans, FINA standards, and also current international standards (ISO, EN, NF, DIN, ASTM). For example: any label must remain legible (marking visible in time).
Single-use devices: bandages, compresses, prostheses, syringes, gloves, soles... undergo so-called "fatigue" mechanical tests: twists, pull-ups, etc.
SgS customers include: Lumibird. For 50 years, the company has been designing, manufacturing and distributing high-performance lasers for scientific, industrial and especially medical use. SGS France conducts electrical safety compliance tests for its subsidiary, Quantel Medical, for its ultrasonic and ophthalmological laser equipment for access to the European or international market.
"We have been working with SGS France since 2017. Each year, we entrust five to seven equipment to them to ensure compliance in electrical safety and essential performance, and to allow us to export to our various markets. Their various laboratories benefit from the required accreditations, testing methods and technical expertise with the obtaining of recognized compliance reports, in 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 of our devices meet these standards for the safety of all," explains Bruno Pages, quality director of the Lumibird Group.
What about accreditations and standards?
The laboratory in Aix in Provence is equipped with testing facilities to carry out tests according to EN/IEC 60601-1 and EN/IEC 61010-1 on a wide variety of devices. It is accredited as a BodyTesting Laboratory (CBTL) by IECEE and has the skills required to issue foreign certification marks (NRTL, inmetro,...).
For ultrasound 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.