It depends on the device class, its intended purpose and the target market. The manufacturer must review the requirements applicable in each territory before starting the process.
November 12, 2026
What is medical device certification?
Medical device certification makes it possible to demonstrate a product’s safety, quality and regulatory compliance before it is placed on the market. In a highly regulated sector, preparing the process correctly not only helps to meet the applicable requirements, but also to reduce regulatory risks, protect launch schedules and maintain the continuity of products already on the market.
The speed of market access increasingly depends on entering the process with complete, traceable and assessable evidence. Therefore, before starting a conformity assessment, the manufacturer must review the product, the quality management system and the technical documentation against the requirements of the target market.
Why does certification determine market access?
For medical devices, developing a safe and effective product is not enough: the manufacturer must be able to demonstrate this to competent authorities, notified bodies or assessment bodies, depending on the territory in which it wishes to operate.
When certification is delayed, the impact may affect the launch schedule, entry into new markets, commercial agreements, tenders, certification transfers or the continuity of products already on the market.
What should a company review before starting the process?
Before starting, it is advisable to review the medical device classification, the product’s intended purpose, the target markets, the applicable regulatory requirements, the status of the quality management system and the available technical documentation.
Clinical, technical or performance evidence, risk management, the traceability of processes, suppliers and controls, existing certifications, the possibility of transferring certifications and the availability of the corresponding assessment body must also be evaluated.
Key certifications and frameworks for medical devices
The most relevant frameworks include ISO 13485, MDR, CE marking, MDSAP, UKCA and the assessment of software as a medical device. Each serves a different purpose: quality system, placing products on the European market, international access, the Great Britain market or the assessment of digital solutions with a medical purpose.
Proper planning makes it possible to identify which requirements apply in each case and which evidence must be prepared before starting the process.
Frequently Asked Questions
It must review classification, intended purpose, target markets, regulatory requirements, quality system, technical documentation, evidence, risk management, traceability and existing certifications.
It may be delayed by incomplete documentation, incorrect classification, lack of evidence, regulatory changes, misaligned internal processes or limited availability of assessment bodies.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
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