Animal-Origin Materials and TSE-BSE Requirements in Egypt

1. Key takeaways

For devices containing animal-origin materials, Egypt handles compliance by writing the conformity item into the CE certificate: where a device contains material of bovine animal origin, its CE certificate must state EU 722/2012 — the regulation that replaced the existing requirements on devices manufactured using animal tissues of TSE-susceptible animals in Directive 2003/32/EC. Annexes 1 and 3 repeat the same requirement in the formula that where the product contains animal-origin material, the CE certificate must state 722/2012, noting that the regulation also covers active implantable devices. The consequence is practical and immediate: EDA performs no separate TSE/BSE technical review, so whatever the CE certificate does not state simply is not demonstrated, and the moment of truth arrives at certificate review, not in the laboratory.

2. Legal basis

3. Expert insights

Insight 1: Egypt has not built its own TSE/BSE assessment system; it hangs the topic on the CE certificate.

The guideline requires the CE certificate to state 722/2012 rather than asking companies to submit standalone TSE/BSE study reports. This certificate-based approach reduces EDA’s review burden but pushes the entire burden of proof onto the company’s CE certificate — what the certificate does not state is treated as not demonstrated. Companies should therefore treat the CE certificate text itself as the compliance deliverable and negotiate the 722/2012 statement with their notified body as early as possible.

Insight 2: the trigger is bovine animal-origin material, but the wording differs slightly in two places.

Annex 1, item 6(i) uses material of bovine animal origin, while Annex 3, item 7(i) uses material of animal origin. The same requirement is worded differently in the two annexes; in practice, prepare against the broader reading (animal-origin material) to avoid being found deficient by omission.

Insight 3: this requirement and the biocompatibility requirement are two independent lines.

Section 6, Fifth requires biocompatibility studies to be performed by an accredited entity, with the ISO/IEC 17025 qualification certificate and proof of the accreditation scope submitted; TSE/BSE, by contrast, travels on the CE certificate. Products containing animal-origin material must satisfy both lines — a CE certificate stating 722/2012 does not waive the biocompatibility study.

Insight 4: products on the US route lack a CE certificate and need a separate solution.

Because the requirement rides on the CE certificate, products on the CFG / 510(k) route that contain animal-origin material will have no 722/2012 statement on their US certificates, and the guideline provides no alternative text for this case. (Practical estimate: confirm in advance, in writing with the EDA registration department, what alternative evidence is acceptable — for example a standalone TSE/BSE assessment declaration or a third-party report; this article does not presume the outcome.)

Insight 5: Class I non-sterile devices are still exempt from the CE certificate, so the requirement has no documentary consequence for them.

The guideline notes in both places that no CE certificate needs to be submitted for Class I non-sterile devices. In the Class I non-sterile plus animal-origin material scenario, the 722/2012 statement therefore never appears in the Egyptian dossier; companies should nonetheless retain the relevant compliance evidence for inspection.

Insight 6: the residual validity rule for certificates applies to this certificate too.

The general requirement of item 7 states that required certificates must be valid for no less than 3 months from the date the dossier is submitted. The CE certificate, as the carrier for verifying 722/2012, is bound by the same rule, so renewal timing at the notified body must be coordinated with the Egyptian filing date.

4. Practical recommendations

1. Determine first whether animal-origin material is present: screen the raw material list against the broader reading, not only bovine.
2. Ask the notified body to state 722/2012 on the CE certificate: raise it at renewal or change at the same time.
3. For US-route products, confirm alternative evidence with EDA in writing: do not presume an exemption.
4. Run the biocompatibility study in parallel: the TSE/BSE statement and biocompatibility are separate lines.
5. Check the CE certificate’s residual validity of at least 3 months: the rule applies equally to certificates carrying the 722/2012 statement.
6. Class I non-sterile: keep compliance evidence on file even though the CE certificate is not submitted.

5. Verification checklist

• □ Raw material list screened against the animal-origin material reading
• □ CE certificate states EU 722/2012 (replacing the requirements of 2003/32/EC on tissues of TSE-susceptible animals)
• □ Biocompatibility study assessed in parallel (ISO/IEC 17025 accredited entity)
• □ US-route products: alternative evidence confirmed with EDA in writing
• □ CE certificate residual validity at least 3 months
• □ Class I non-sterile products: compliance evidence retained for inspection

Regulatory information verified as of October 29, 2026. The animal-origin material requirements follow the current text of Annex 1, item 6(i) and Annex 3, item 7(i) of EDREX: GL.CAMD.002 Version 2; the cited EU regulation and directive follow the original texts on EUR-Lex.

• Local resources in Egypt: GRZAN supports manufacturers from the Chinese mainland and overseas in dealing with the Egyptian Drug Authority (EDA) on medical device registration, import approval and change applications, including registration applicant scheme design (import company / local factory / scientific office), scientific committee evaluation preparation, reference-country free sale certificate route argumentation, Arabic labelling and IFU localization, and vigilance system and periodic reporting set-up.
• Service capabilities: product attribute and risk classification (device Class I–III / IVD Class A–D), registration and re-registration, system and bundled registration applicability, three-category change determination, import approval and the annual import plan, vigilance reports and field safety corrective action support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.