MDR Article 117 and the Notified Body Opinion

What Is MDR Article 117?

MDR Article 117 is the provision of Regulation (EU) 2017/745 that amends section 3.2, point 12 of Annex I to Directive 2001/83/EC. It links medicines law to device law for products where the drug and the device form one integral product.

These products are authorised as medicinal products, so the European Medicines Agency (EMA) or a national competent authority remains the decision maker. However, the authority does not assess conformity of the device part. The dossier must therefore show that the device part meets the relevant General Safety and Performance Requirements (GSPRs) in Annex I of the MDR.

In practice, MDR Article 117 asks one question: is there evidence of device conformity in the dossier? If the evidence is a declaration of conformity or an EU certificate, no opinion is needed. If neither exists and a notified body would normally be involved, the applicant must obtain an NBOp.

When Is a Notified Body Opinion Required?

An NBOp is required when the dossier contains no conformity result for the device part and that device, if used separately, would need notified body involvement. EMA sets out the expected evidence by device class in Table 1 of its Q&A.

What about products authorised before 26 May 2021?

MDR Article 117 is not retrospective. It does not apply to integral products already authorised, or to applications submitted, before 26 May 2021. A major device change or a new device after that date still needs the relevant declaration, certificate or opinion.

• Certificates issued under Directives 90/385/EEC or 93/42/EEC may support the application while they remain valid under the MDR transitional provisions.
• EMA states that class I declarations drawn up before 26 May 2021 may be accepted until 31 December 2028.
• The evidence should ideally be filed with the application. Late documents must arrive before the opinion on the medicinal product, and may cause additional clock stops.

How Do You Obtain an NBOp Under MDR Article 117?

These seven steps give a practical sequence. Exact requirements vary by notified body, so agree the details early with the one you select.

1. Confirm the product typeEstablish whether the product is integral, co-packaged, referenced or ancillary, and document the principal mode of action.
2. Classify the device partApply the MDR Annex VIII rules as if the device were used separately. This shows whether notified body involvement is needed.
3. Check existing evidenceLook for a valid declaration of conformity or EU certificate. If one exists, an NBOp may not be needed.
4. Close the GSPR gapsComplete the GSPR checklist and generate missing evidence, such as biological evaluation, risk analysis, usability and packaging data.
5. Select a notified bodyChoose a body designated under the MDR for the device type, and confirm that it accepts Article 117 applications. Check its fees and capacity.
6. Submit and answer questionsProvide a legible, searchable and bookmarked file with no access protection. Track each question from the reviewer until it is closed.
7. File the opinion in the dossierInclude the issued opinion in the marketing authorisation application, and keep it aligned with the device described in the dossier throughout the review.

Which Changes Need a New Notified Body Opinion?

MDR Article 117 continues to apply after authorisation. EMA expects a new or updated opinion when a new device is introduced, for major device changes, and for medicinal product changes that may affect device performance. Variations follow the current EU variations guidelines, which EMA notes apply from 15 January 2026.

Team-NB’s lifecycle position paper offers typical examples, and the list is not exhaustive.

The marketing authorisation holder analyses each change and makes the final decision. Where no new opinion is obtained for a variation, the holder must justify this in Module 3.2.R. Agreements with the device manufacturer should also cover how device changes are communicated, as device post-market data can trigger them.

MDR Article 117 Support from I3CGLOBAL

I3CGLOBAL is a global regulatory consulting company for medical devices, IVDs, pharmaceuticals and life sciences. Our QARA team helps applicants prepare technical documentation, work with notified bodies and meet MDR Article 117 requirements. The notified body issues the opinion, and the medicines authority makes the authorisation decision.

Official References and Related Guides

• Regulation (EU) 2017/745 (MDR), Articles 1(8), 1(9) and 117
• Directive 2001/83/EC, Annex I, section 3.2, point 12
• EMA Q&A on implementing the MDR and IVDR, Rev. 6 (December 2025)
• EMA guideline on quality documentation for medicinal products used with a medical device
• EMA presentation: notified body opinion, the assessor’s view
• Team-NB: documentation requirements, substantial changes and opinion template

• Medical Device Technical File
• GSPR Checklist
• Clinical Evaluation Report
• Post-Market Surveillance
• MDR Article 17
• CE Certification Cost

Updated 4 November 2026 | Author: Sobha Augustine, Founder, I3CGLOBAL | Reviewed by: Asha Johnson, Manager, I3CGLOBAL