Medical devices — from tubing, catheters, and surgical instruments to diagnostic equipment and wearable monitors — bring their materials into direct or indirect contact with patients and users. Ensuring that those materials do not contain or release harmful substances is a core safety obligation and a market-access requirement worldwide. Chemical testing — the laboratory analysis of restricted and hazardous substances in the device and of what migrates from it — is how manufacturers prove it. CIRS Testing provides a complete medical device chemical testing service, built around the chemical-substance requirements of the EU MDR, REACH, RoHS, the POPs Regulation, China NMPA/GB, and US FDA / ISO 10993 frameworks.
Why Chemical Testing Matters for Medical Devices
- Patient exposure is direct and repeated. Device materials, plastics, plasticizers, colorants, and adhesives can release substances into the body, or into the drugs and fluids the device contacts.
- Regulators require it. The EU MDR/IVDR (Annex I), REACH, RoHS, and the POPs Regulation all set binding chemical limits; non-compliance blocks market access and triggers recalls.
- The substance lists keep growing. SVHC, POPs, PFAS, and CMR restrictions expand continuously — a compliant material today can become a non-conformity tomorrow.
- Liability and brand. Chemical non-compliance is a leading cause of medical device recalls and regulatory enforcement.
What Medical Device Chemical Testing Covers
The core of our service is targeted chemical analysis of the substances most likely to be restricted in a device. The applicable scope is defined product-by-product; the parameters below are the most commonly requested.
Parameter | Typical substances | Why tested / representative limit |
Heavy metals | Pb, Cd, Hg, Cr(VI) | RoHS 0.1% (Cd 0.01%); REACH Annex XVII; ICH Q3D / USP <232> |
Phthalates / plasticizers | DEHP, DBP, BBP, DIBP, DINP, DIDP | PVC devices; MDR/REACH CMR; RoHS 0.1% each |
SVHC screening | 250+ Candidate List substances, updated 2×/year | REACH 0.1% (w/w) communication & notification |
substance-specific (lead, PAHs, certain phthalates, etc.) | per individual restriction | |
PBDEs, HBCDD, SCCP, PFOA, PFHxS | EU POPs Regulation (mg/kg–μg/kg) | |
PFOA, PFHxS and related | POPs; fast-emerging restrictions | |
CMR & endocrine disruptors | CMR 1A/1B, EDCs | MDR — invasive & body-contact devices |
8 REACH PAHs incl. BaP | ≤0.5 (toys/childcare) / 1 mg/kg (general) | |
BPA & phenolics | Bisphenol A | REACH restriction; California Prop 65 |
Nitrosamines | NDMA and related | risk-based; heightened regulatory scrutiny |
Residual solvents & monomers | manufacturing residues | ICH Q3C; ISO 10993-17 risk assessment |
Which Regulations Drive These Chemical Requirements
Different rules drive different chemical obligations, and they apply in parallel. We map your device to the relevant ones so the test scope matches exactly the limits you must meet.
Regulation | Chemical obligation it imposes |
EU MDR / IVDR (2017/745, 2017/746) | Annex I: control chemical risks; restrict, justify or disclose CMR 1A/1B and endocrine-disrupting substances in invasive and body-contact devices (labelling above 0.1% w/w). |
REACH (EC 1907/2006) | SVHC above 0.1% (w/w) → communication and ECHA notification; Annex XVII substance-specific restrictions. |
EU RoHS (2011/65/EU) | Ten restricted substances (incl. four phthalates) in electrical medical devices and IVDs. |
EU POPs (EU 2019/1021) | Restricts listed persistent organic pollutants — flame retardants, PFAS, SCCP, etc. |
China NMPA / GB 16886 | Chemical safety and materials data required to support domestic registration. |
US FDA / ISO 10993 | Chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17). |
California Proposition 65 | Listed carcinogens and reproductive toxicants (e.g., lead, DEHP, BPA). |
Spotlight: CMR Substances and Phthalates — the Highest Chemical Risk
CMR 1A/1B and endocrine-disrupting substances are the EU MDR’s top chemical target for invasive and body-contact devices. Phthalates — above all DEHP, used to soften PVC in tubing, fluid bags, and blood sets — are restricted under both REACH and the MDR and face ongoing tightening. CIRS Testing helps manufacturers screen, quantify, and where needed identify substitution pathways for these high-risk substances.
Beyond Chemical Testing
Chemical analysis is often part of a broader safety file. Through our testing network we also support the related assessments that frequently accompany it — kept separate from, and complementary to, the chemical-substance testing above:
Biocompatibility (ISO 10993 series) — including -18 chemical characterization and -17 toxicological risk assessment, plus biological endpoints such as cytotoxicity (-5), irritation (-23), and sensitization (-10).
Sterilization residuals — ethylene oxide (EO) and ECH residuals per ISO 10993-7.
Materials characterization & packaging/stability — materials identification, and packaging and shelf-life/aging studies.
Our Chemical Testing Services
Regulatory scoping — identify the chemical rules and limits applicable to your device, target market, and contact category.
Tailored test plan — exactly the parameters required — no duplicate or unnecessary testing.
Chemical analysis — heavy metals, phthalates, SVHC, Annex XVII, POPs/PFAS, CMR, PAHs, BPA, nitrosamines, residual solvents.
Documentation — declarations of compliance and material/ingredient declarations from the supply chain.
Substitution & change-control — practical guidance on replacing restricted substances and managing material, colour, or supplier changes.
Why Choose CIRS Testing
- Multi-framework chemical expertise — one coherent chemical data set across MDR, REACH, RoHS, POPs, NMPA/GB, and FDA/ISO 10993.
- Accredited accuracy — internationally recognized reports accepted by market-surveillance authorities and notified bodies.
- Targeted, cost-effective scope — we test only what is necessary for your device and its materials, reducing cost and time-to-market.
- Forward-looking insight — we track SVHC updates, RoHS expansion, and PFAS developments so your data stays current.
For medical device chemical testing or compliance support, please contact CIRS Testing at test@cirs-group.com, or reach out to us via WhatsApp by scanning the QR code.
