Article 117: Your Certificate Expires but Your Clinical Work Never Did

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

in
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The confusion is understandable. Article 117 allows devices with valid MDD certificates to remain on the market during a transition period. Many teams interpret this as temporary relief from full MDR clinical evaluation requirements.

That interpretation costs them months in certification delays.

Because Article 117 addresses market access timing. It does not exempt you from MDR clinical evaluation standards when you apply for a new certificate under the regulation.

What Article 117 Actually Says

Article 117 of MDR 2017/745 establishes that certificates issued under MDD 93/42/EEC or AIMDD 90/385/EEC remain valid until their expiry date, but no later than May 2024 for most devices (with extensions to May 2025 or May 2026 under specific conditions outlined in subsequent regulations).

During this validity period, devices can continue to be placed on the market.

But here is what matters for clinical evaluation work: Article 117 does not define what clinical evidence you need when you apply for MDR certification. That is determined by MDR Annex XIV and the general safety and performance requirements in Annex I.

The transitional provision affects your certificate validity and market access timeline. It does not create a transitional standard for clinical evaluation depth or rigor.

Where the Confusion Comes From

The confusion typically starts with well-meaning regulatory timelines. Teams see their MDD certificate valid until 2024 or later. They plan to submit for MDR certification in late 2023 or early 2024. They assume they have time to build evidence gradually.

Then they prepare the technical documentation. They update the clinical evaluation report. They realize their existing clinical data was built for MDD, not MDR.

Under MDD, a well-constructed equivalence argument with limited clinical data could support certification for many devices. Under MDR, equivalence requirements are stricter (MDR Annex XIV Part A Section 3). Clinical data expectations are higher. PMCF is not optional.

So they face a choice: delay submission to generate more data, or submit with what they have and hope the Notified Body will accept a plan to close gaps later.

Most choose the second option. Most regret it.

What Notified Bodies Actually Do

Notified Bodies do not have discretion to apply MDD standards to MDR submissions. They are audited on their conformity assessment processes. Their designation depends on demonstrating that they evaluate technical documentation against current regulatory requirements.

When you submit under MDR, they assess your clinical evaluation report against MDR Annex XIV. They look for compliance with MDCG 2020-5 and MDCG 2020-6. They verify that your literature search was systematic and comprehensive. They check that your equivalence demonstration meets the three-part test in Annex XIV Section 3.

If your clinical data reflects MDD-era practices, they issue non-conformities. The fact that your device was previously certified under MDD does not change their assessment criteria.

I have reviewed files where manufacturers included a note in the CER saying “additional clinical data will be collected during PMCF.” The Notified Body responded that PMCF is for ongoing evaluation, not for closing gaps that should have been addressed before market access.

That is the correct interpretation of MDR Article 61 and Annex XIV Part B.

The Clinical Evaluation Requirements That Apply Now

If you are preparing an MDR submission today, even under Article 117 transitional timelines, your clinical evaluation must meet these standards:

Comprehensive literature review. Not a targeted search for favorable publications. A systematic, reproducible search strategy covering all relevant databases, with clear inclusion and exclusion criteria, documented according to MDCG 2020-5 Section 6.3.

Valid equivalence demonstration if you claim equivalence. You must demonstrate equivalence in clinical, technical, and biological characteristics. The equivalent device must have sufficient clinical evidence. You must have access to the equivalent device’s data (MDR Annex XIV Part A Section 3). If you cannot meet all three conditions with robust documentation, you cannot claim equivalence under MDR.

Appraisal of all relevant data. Every study in your literature search must be appraised for relevance and scientific validity. You cannot exclude unfavorable data without documented justification. Your CER must address conflicting findings and explain how you weighted different evidence levels.

Analysis against each applicable general safety and performance requirement. Not a general statement that the device is safe and performs as intended. A specific analysis showing how your clinical data demonstrates conformity with each applicable requirement in Annex I (MDR Annex XIV Part A Section 4).

Benefit-risk determination with supporting data. Quantitative when possible, qualitative when necessary, but always traceable to your clinical evidence base. The benefit-risk profile must be favorable for the intended patient population and intended use.

PMCF plan integrated with your risk management. Not a separate document created for compliance. A functional plan that identifies residual uncertainties, defines data collection methods, specifies acceptance criteria, and describes how results will feed back into the clinical evaluation update cycle.

None of these requirements are negotiable. None are phased in over time. They all apply the moment you submit for MDR certification.

Why “We Will Improve During PMCF” Does Not Work

I understand why teams plan to strengthen their clinical evidence through PMCF after certification. It seems logical. You get to market, you collect real-world data, you continuously improve your evidence base.

But PMCF under MDR is not designed to compensate for pre-market evidence gaps.

MDR Article 61(1) states that PMCF is “a continuous process that updates the clinical evaluation.” It assumes you had sufficient clinical evaluation to achieve certification in the first place.

MDCG 2020-7 describes PMCF as part of a “closed-loop process” where post-market data confirms or refines your understanding of safety and performance. Not establishes it for the first time.

When a Notified Body sees a clinical evaluation report with significant evidence gaps and a PMCF plan that promises to fill those gaps, they interpret that as insufficient pre-market clinical evaluation. They issue a non-conformity requesting more data before certification.

The response manufacturers typically try is to argue that their device has been on the market for years under MDD with no significant safety issues. That post-market experience should count as clinical evidence.

It can count. But only if it is documented systematically, analyzed according to PMCF principles, and integrated into the clinical evaluation. A general statement about market history is not clinical evidence. Proper collection and analysis of that historical experience might be, but few manufacturers have that documentation readily available from their MDD years.

What You Should Do Right Now

If your device is still on the market under an MDD certificate and you have not yet submitted for MDR certification, treat your remaining time as clinical evidence development time, not administrative preparation time.

Conduct your MDR-compliant literature review now. Identify evidence gaps now. If you plan to claim equivalence, verify you can meet all three equivalence conditions with documented proof now.

If gaps exist, determine whether you can close them with additional literature, with data from your equivalent device manufacturer (if you have a formal agreement), or with a well-designed clinical investigation.

For many devices, particularly lower-risk devices with well-established designs, the literature may be sufficient. But you will not know until you do the systematic search and appraisal according to MDCG 2020-5.

If you have been on the market for years, start systematic PMCF data collection immediately. Define clear data collection methods. Establish acceptance criteria. Document findings in periodic PMCF evaluation reports. This data can strengthen your clinical evaluation at submission time.

The time between now and your MDR submission deadline is your opportunity to build a robust clinical evidence base. If you use that time for administrative updates and formatting while leaving clinical evidence for later, you will face major non-conformities during assessment.

The Reality of Assessment Timelines

Even with complete technical documentation, MDR certification takes longer than MDD certification took. Notified Bodies have larger assessment workloads, more detailed requirements to verify, and more documented evidence to review.

If your clinical evaluation has gaps, the timeline extends significantly. Each non-conformity requires a response, often with additional data or analysis. The Notified Body must review your response. If they are not satisfied, they issue follow-up questions.

I have seen initial assessments turn into 18-month cycles because the clinical evaluation was not MDR-ready at submission.

That is 18 months you could have used to collect clinical data, conduct post-market surveillance systematically, or negotiate access to equivalent device data. Instead, you spend it responding to non-conformities and trying to convince your Notified Body that your evidence is sufficient.

Article 117 gave manufacturers time. But time only helps if you use it to address the actual requirements, not to delay addressing them.

The Path Forward

Article 117 transitional provisions are not clinical evaluation waivers. They are timeline provisions that allow continued market access while you prepare for full MDR compliance.

The clinical evaluation requirements that apply to your next MDR submission are not transitional. They are not phased. They are the full requirements in Annex XIV, interpreted according to current MDCG guidance documents.

If you submit before your clinical evaluation is ready, you will face delays, non-conformities, and possibly rejection.

If you use your remaining time under Article 117 to systematically build your clinical evidence base, your MDR submission will be stronger, your assessment will be faster, and your certificate will be more defensible during surveillance and renewals.

The clock is running. But you control how you use the time that remains.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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