CE Certificate Verification and NANDO Checks for Egypt Registration

1. Key takeaways

Egypt verifies CE certificates along two parallel lines. The first line is verification of the certificate itself: whether the notified body is accredited, with the EU NANDO database as the reference, and whether the annex path matches the classification (Class I sterile, IIa, IIb and III each have prescribed combinations). The second line is verification of transition-period applicability: devices affected by the transition arrangements of REGULATION (EU) 2023/607 must, under EDREX: NP.CAMD.003 Version 2 (issued and effective on 10 October 2023), submit a legal manufacturer letter and a notified body letter, plus a Member State competent authority letter substituting for the CFS or a valid free sale certificate (imports only).

2. Legal basis

3. Expert insights

Insight one: NANDO is the officially designated entry point for notified body verification in Egypt, not merely a reference tool.

Section 9 of GL.CAMD.007 states under the heading of accredited notified bodies that the list is available on the NANDO website (ec.europa.eu/growth/tools-databases/nando/). Companies should verify the notified body number and status before submission, because where the body number printed on the certificate has since been withdrawn or its scope reduced, a correction request follows directly.

Insight two: the CE annex combinations escalate by classification, and the certificate version must match the class.

Section 9 lists the combinations: Class I sterile, a CE certificate under Annex V or Annex II.3; Class IIa, Annex V or Annex II.3; Class IIb, CE Annex II.3, or CE Annex V with CE Annex III; Class III, CE Annex II Section 3 with CE Annex II Section 4, or CE Annex III with CE Annex V. The guide also requires the CE certificate to state the scope of the certificate (the category or family of the products submitted), the certificate number, the date of issue and the period of validity.

Insight three: the scope of NP.CAMD.003 has precise date and certificate boundaries.

The First item applies to quality certificates issued between 25 May 2017 and 26 May 2021 that were valid on 26 May 2021 and had not been withdrawn, issued under Directive 93/42/EEC (medical devices) or Directive 90/385/EEC (active implantable devices). The definition is technical: the certificate must satisfy both the issue window and the validity condition, and failing either one, the transitional mechanism does not apply. Companies should map every legacy certificate against both conditions before drafting any letters.

Insight four: the notified body letter carries an issue-timing substitution rule that is the easiest detail to overlook.

The First item provides that for quality certificates valid on 26 May 2021 but expired before 20 March 2023, a notified body letter explaining that the grace period applies may be submitted, provided the letter bears a date of issue earlier than the expiry date of the quality certificate. Where neither is obtainable, a letter from the competent authority of the country of origin may be submitted, stating that an exemption from the applicable conformity assessment procedure has been granted under Article 59(1), or that the manufacturer has been required to apply the applicable procedure under Article 97(1).

Insight five: the requirements for IVDs differ, and only one manufacturer letter is needed.

The Secondly item addresses in vitro diagnostics: for quality certificates issued before 26 May 2022 under Directive 98/79/EC, the legal manufacturer must submit a letter declaring that no significant changes have been made to the design and the intended use of the product. The IVD pathway accordingly requires no notified body letter, but the declaration must be accurate, since it is the sole evidentiary basis of the transitional mechanism.

Insight six: the official EDREX text prints the month of Regulation 2023/607 as March 2030, a typographical error in the source.

The title of NP.CAMD.003 issued by the EDA contains the wording REGULATION (EU) 2023/607 of March 2030, whereas both the official European Union text and the body of the EDA document refer to March 2023. Companies citing the notice should rely on the regulation itself (EUR-Lex CELEX:32023R0607) rather than copying the misprinted year into their dossiers.

Insight seven: changes mentioned in the extension letters are governed by a dedicated handling mechanism of their own.

The EDA has separately issued a handling mechanism for changes mentioned in the notified body extension letters but not recorded in the device registration license. It divides such changes into three categories: those to be submitted to the change department before the change occurs or immediately after it (code changes, additions and removals, changes of the legal factory name or address, additions of a legal factory, device description); those requiring an application immediately after obtaining the quality certificate under EU 2017/745 (upward or downward classification changes, significant changes of design or intended use); and those requiring no application to the change department (changes of trade name, provided the device is registered under the new trade name and may be traded only after the registration notification is reissued). Holders of extension letters should reconcile their change log against this mechanism. (Practical estimate: the current version and document number of the mechanism must be verified in the Notice to applicant section of the EDA website.)

4. Practical recommendations

1. Check NANDO before submission: verify the notified body number and accreditation status.
2. Verify the CE annex combination by classification: look at the annex path, not merely at whether a certificate exists.
3. Determine whether the device falls within the scope of NP.CAMD.003: check both conditions, issue between 2017-05-25 and 2021-05-26 and validity on 2021-05-26.
4. Where the certificate has already expired, check the issue date of the notified body letter: it must precede the expiry date of the quality certificate.
5. For IVDs, prepare only the manufacturer letter: declaring that there have been no significant changes to design and intended use.
6. Handle changes mentioned in extension letters separately: assess each against the three-category mechanism to determine whether the change department must be involved.
7. Cite the regulation from the EUR-Lex original: do not copy the misprinted year from the EDA document.

5. Verification checklist

• □ The notified body has been verified in the NANDO database
• □ The CE certificate annex path has been checked by classification (Class I sterile / IIa / IIb / III)
• □ The CE certificate states the scope, the number, the date of issue and the period of validity
• □ Applicability of NP.CAMD.003 has been determined (valid on 2021-05-26 and not withdrawn)
• □ The manufacturer letter and the notified body letter are in place (devices)
• □ The letter of the competent authority of a Member State or a valid FSC is in place (applies to imports)
• □ For IVDs, the manufacturer declaration of no significant changes has been prepared
• □ Changes mentioned in extension letters have been handled against the three-category mechanism

Legal information verified as of 29 October 2026. The CE verification requirements described in this article follow Section 9 of EDREX: GL.CAMD.007 Version 2; the implementation mechanism for the 2023/607 transition follows EDREX: NP.CAMD.003 Version 2 (issued and effective on 10 October 2023) and EUR-Lex CELEX:32023R0607.

• Egypt local resources: GRZAN assists manufacturers from the Chinese mainland and overseas with medical device registration, import approval and change applications before the Egyptian Drug Authority (EDA), including design of the registration applicant arrangement (importing company, local factory or scientific office), preparation for scientific committee assessment, argumentation of routes for obtaining free sale certificates from reference countries, Arabic localization of labels and instructions for use, and the establishment of vigilance systems and periodic reporting.
• Service capabilities: product attribute determination and risk classification (devices Class I–III / IVD Class A–D), registration and re-registration, applicability determination for system registration and bundled registration, three-category determination of changes, import approval and annual import plans, and support for vigilance reports and field safety corrective actions.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.