When a Device Changes Hands: The Technical File and CER Handover Checklist

Qmedify Regulatory Team · Last updated October 2026

Johnson & Johnson has just sold its Laminar left atrial appendage (LAA) closure technology to a newly formed company, and reports say it is also exploring a sale of its orthopedics unit. When a device changes hands, what does the buyer actually take on?

The buyer takes on the duty to keep the clinical evidence for the device current and defensible, plus the technical documentation behind it. Before closing, test four things: who the legal manufacturer will be, whether the Clinical Evaluation Report (CER) is up to date, whether equivalence claims still hold, and whether post-market clinical follow-up (PMCF) data exists and can be used. Gaps found during due diligence can shape the price and the plan, while gaps found after closing can only be fixed at your cost.

What do the recent deals tell us?

Three September 2026 stories show how often devices and technologies now move between owners. None of the reports we read says anything about CE marking, so the regulatory picture below is ours, not theirs.

J&J and Jaguar LAA. MDDI reported on 17 September 2026 that J&J sold Laminar to Jaguar LAA, a new company backed by Santé Ventures and former Laminar management. The price was not disclosed. The technology never reached the market, because J&J suspended its pivotal clinical trial over a concern that the implant could unwrap after placement.
J&J's orthopedics unit. MDDI relayed a Bloomberg report that J&J is in early talks to sell DePuy Synthes to Apollo Global Management for about $20 billion. The talks may still end without a deal.
GE HealthCare and Sofie Biosciences. MDDI reported, citing the Financial Times, that GE HealthCare is in talks to buy the theranostics company for up to $1 billion. Neither company had commented. Not every asset in a deal like this is a medical device, so check first which regulatory regime applies.

The Laminar case is a useful reminder. A pre-market technology has no CE certificate to inherit, but it does come with clinical development data and open safety questions. A marketed device comes with a certificate, a CER and years of post-market data, and with the obligations that go with them.

What does a buyer inherit under the EU MDR?

It depends on the deal structure and on whether the device is already on the market. This is general information, not legal advice for a specific transaction.

Situation	Who is the legal manufacturer?	What it means for the CER and technical file
Share purchase of the company	Usually unchanged, because the legal entity stays the same	Documentation stays with the entity, but a change of ownership or quality system may still need discussion with the notified body
Asset purchase of a marketed device	The buyer, once it takes over the manufacturer role	The buyer must be able to stand behind the CER, PMCF and technical documentation as its own
Purchase of a pre-market technology	The buyer, when it places the device on the market	No certificate to inherit; the buyer inherits the development file, trial data and open issues

Once you are the manufacturer, the MDR (Regulation (EU) 2017/745) puts several duties on you. Article 10(3) requires a clinical evaluation under Article 61 and Annex XIV, including PMCF. Article 10(10) requires a post-market surveillance (PMS) system under Article 83.

Article 10(8) also requires you to keep the technical documentation, declaration of conformity and certificates for at least 10 years after the last device is placed on the market. For implantable devices the period is at least 15 years.

Legacy devices (those still on the market under the old directives through the transition in Article 120(3)) add a wrinkle. They may only stay on the market if there are no significant changes in design or intended purpose.

MDCG 2020-3 Rev. 1 (September 2023) treats a change of manufacturer name, address or legal form as usually administrative. A sale to an unrelated company is a different situation, so ask your notified body how it will treat it.

What should the handover checklist cover?

Use the six checks below as a gap register. For each one, record what you were given, what is missing and who will close the gap.

1. Who is the legal manufacturer, and what covers the device?

Which certificates exist, and which entity do they name?
Does the declaration of conformity, the labelling and the instructions for use name the right manufacturer?
Are the manufacturer and device registrations, and the authorised representative, ready to change?
Does the sale agreement give you transition support from the seller, and for how long?

2. Is the CER current?

A CER is a living document, not a one-off report. Article 61(11) requires it to be updated through the device's life with PMS and PMCF data. For class III and implantable devices, the PMCF evaluation report is to be updated at least annually.

When was the last CER version approved, and when is the next update due?
When was the last literature search, and is the search protocol documented and repeatable?
Does the CER include the complaints, vigilance and PMCF data gathered since the last version?
Was it written to MDR and Annex XIV, or to the older MEDDEV 2.7.1 Rev. 4 approach? An older CER usually needs a full gap assessment, not a light refresh.
Does the benefit-risk conclusion still match the latest safety data?

3. Do the equivalence claims still hold?

Equivalence means showing that another device is the same in technical, biological and clinical characteristics. MDCG 2020-5 (April 2020) sets out how to demonstrate all three, and warns that public information is rarely enough.

For implantable and class III devices, Article 61(5) adds two conditions when you rely on another manufacturer's device. You need a contract that gives you full, ongoing access to its technical documentation, and the other device's clinical evaluation must itself comply with the MDR.

A sale can break an equivalence claim in two ways. Look at both:

The buyer's device relies on a device the seller keeps. What used to be a modification of the manufacturer's own device may become a claim against a third party's device. In our reading, that triggers the contract and data-access conditions. Interpretation can vary, so confirm with the notified body.
Other manufacturers rely on the divested device. Their access agreements were signed with the seller. Check whether those contracts transfer, and who now owes them what.

4. Does PMCF data exist, and can you use it?

Is there a PMCF plan, and do PMCF evaluation reports show it was actually carried out?
Are registries, studies or clinical sites involved, and do the contracts transfer to you?
Who holds the underlying data, and are you allowed to use it for clinical evaluation, including under data protection rules?
If a clinical study is running, who is the sponsor after closing, and does the authorisation need updating?

A PMCF plan with no executed activities is a gap. So is data that exists but that you may not use.

5. Is the technical documentation complete and retrievable?

Is the file complete against Annexes II and III, including the risk management file and design history?
Can you reach the supplier data, test reports and raw results the CER cites?
Is a safety and clinical performance summary in place, where one is required?
Does anything important sit only in the heads of the seller's staff?

6. What do PMS and vigilance records show?

What do the complaints, incident reports and field safety corrective actions say, and are they all reflected in the CER?
Are there open corrective and preventive actions that affect clinical claims?
Are the latest periodic safety update reports consistent with the CER's conclusions?

When should you run the gap assessment?

The earlier the better. Each phase asks a different question.

Phase	Main question	Typical output
Before signing	Is the evidence strong enough to support the price and the plan?	Short red-flag report on certificates, CER age, equivalence and PMCF
Before closing	What must the seller deliver or fix?	Gap register tied to closing conditions or transition services
After closing	How do we get to a defensible CER and file?	Remediation plan with owners, dates and a CER update schedule

How can AI-assisted gap analysis speed up due diligence?

Due diligence windows are short, and a data room can hold hundreds of documents. This is where AI assistance can save the most time, as long as a qualified person makes the calls.

In our view, AI is useful for:

extracting key facts from each CER, such as version, date, device classification, search dates and equivalent devices,
listing claims in the CER that have no cited reference,
cross-checking the CER against PMS, PSUR and complaint data for inconsistencies,
flagging which sections would be out of date given the search date,
building the first draft of the gap register for expert review.

It has limits. It can only assess what is in the data room, so a missing document is itself a finding that a person must spot and chase. It does not decide whether an equivalence claim is acceptable or whether a benefit-risk conclusion holds.

Treat data room documents as confidential. Check how your tool handles data and what your confidentiality agreement allows. Keep a record of what the tool produced, who reviewed it and what they changed, as we describe in our article on responsible AI in regulatory affairs.

Here is an illustrative example. A buyer receives the CER for an implantable device, last updated two years ago. The AI-assisted review flags that the last literature search is old, that the PMCF section cites a plan but no report, and that the equivalence claim rests on a device the seller keeps. A regulatory specialist confirms each point, and the buyer leaves the negotiation with three concrete conditions instead of a vague worry.

How does this connect to the proposed MDR reform?

The Commission's December 2025 proposal would change parts of clinical evaluation, including how equivalence and PMCF reporting work, but it is not law yet. Until it is adopted, the current rules apply, and a buyer cannot price in changes that may not arrive. We cover the details in our article on the MDR reform and CER strategy.

Key takeaways

A buyer of a marketed device takes on the duty to keep its CER, PMCF and technical documentation current and defensible.
A pre-market technology has no certificate to inherit, but it brings development data and open safety questions.
Check six areas: legal manufacturer and certificates, CER currency, equivalence, PMCF, technical file and PMS records.
Equivalence claims can change character in a sale, so test both the buyer's claims and other companies' claims on the divested device.
AI-assisted gap analysis can speed up due diligence, but qualified experts must verify findings and own the conclusions.

FAQ

Does a buyer need a new CER after acquiring a device?

Not automatically. A current, MDR-compliant CER can often be reused, but the new manufacturer is responsible for it and must be able to defend it. Plan an update to reflect the new ownership, any new data and any gaps you find.

Does a share purchase change who the legal manufacturer is?

Usually not, because the legal entity stays the same. You should still ask the notified body whether the change of ownership or quality system needs notification.

What if the CER relies on equivalence with a device the seller keeps?

Treat it as a risk to the claim. Check whether the contract and data-access conditions in Article 61(5) are met, and whether you need new evidence instead.

Can AI do the CER due diligence for us?

It can speed up the review, but it cannot replace expert judgement. Use it to extract, cross-check and flag, then have a qualified person confirm each finding.

Is the checklist different for a device that is not yet on the market?

Yes. There is no certificate or post-market data to review, so focus on the clinical development data, any suspended or running studies and the evidence plan for CE marking.

Buying or selling a CE-marked device? Contact the Qmedify Regulatory Team to talk through a CER and technical file gap assessment.