NSAI NB 0050 Medical Devices Divestment 2026: Stay vs Transfer Playbook
Playbook for NSAI NB 0050 clients on the 2026 divestment: confirmed facts, stay-vs-transfer tree, MDR Article 58, IVDR Article 53, MDSAP.
The National Standards Authority of Ireland (NSAI) has announced a decision to divest its medical-device department. For manufacturers holding CE certificates under Notified Body 0050 (NSAI), NSAI ISO 13485 certificates, or NSAI Medical Device Single Audit Program (MDSAP) certification, the immediate questions are legal validity, audit continuity, and whether a transfer must start now.
The NSAI announcement does not itself invalidate NB 0050 certificates, no completed sale has been publicly disclosed, and manufacturers should not treat rumours or competitor transfer offers as a reason to move every certificate at once.
This playbook is specific to the 2026 NSAI medical devices divestment and orderly-exit communications. It separates confirmed facts from unknowns, sets a stay-versus-transfer trigger tree, and maps the legal pathways that actually apply: MDR Article 58, IVDR Article 53, MDR Article 46 / IVDR Article 42, IAF MD 2:2023, and the official MDSAP transfer FAQ. Generic notified-body selection and MDSAP program questions belong in the background guides linked below—not on this page.
What Did NSAI and the Irish Department of Enterprise Actually Announce About the Medical-Device Department and NB 0050?
Two public communications define the current record. They overlap, but they are not the same document and they do not say the same thing.
NSAI management communication (Claire Dyson)
Claire Dyson, NSAI Director of Medical Devices, posted in August 2026 that NSAI announced its decision to divest the medical-device department to an established testing, inspection and certification (TIC) organisation. The post does not name a buyer. On operational consequences, the wording is specific:
Short term: "very little changes." Services continue as normal, "and there is no impact on our clients, work in progress, or the certificates we maintain."
Longer term: NSAI "hope[s] to combine forces with another established organisation to consolidate expertise and knowledge."
Client channel: correspondence about the announcement, and client tools, go through medfuture@nsai.ie.
That post is a management communication. It is not a completed-sale notice, not a NANDO designation change, and not an MDR Article 46(3) planned-cessation notice to manufacturers.
Department of Enterprise statement (reported 8 August 2026)
The Irish Times (Emmet Malone, 8 August 2026) quoted a Department of Enterprise statement: Minister Peter Burke had been notified that the NSAI board decided on 30 July 2026 to begin an orderly exit from the provision of medical product certification services. The quoted reasons are financial viability of the service, staff recruitment and retention, maintaining designation by the Health Products Regulatory Authority (HPRA), productivity issues, and market competition. The Minister's quoted comment trusts NSAI to minimise impact on staff and customers.
The same Irish Times report also covers a related but distinct labour story: NSAI's intention to close its medical devices testing division, with up to 20 redundancies, industrial action over a proposed clinician redundancy, and a work-to-rule. Unite is quoted warning that disruption to certification could pose significant risks for regional manufacturers. That labour reporting is real counter-evidence to a purely frictionless reading of Dyson's short-term continuity message. It is still not a certificate-invalidity notice.
What NSAI's own website still shows
As of 24 August 2026, NSAI's medical-device certification pages still advertise MDR, IVDR, ISO 13485 and CE marking. The MDR / IVDR information page still states designation under both regulations and points readers to NANDO. The medical-device "latest news" listing retrieved the same day had no 2026 divestment or orderly-exit client notice (the newest items remain 2023 transition and IVDR designation posts).
Confirmed Facts, Unknowns, and What Not to Claim About the NSAI NB 0050 Divestment
| Parameter | Status as of 24 August 2026 | Basis |
|---|---|---|
| Existing NSAI NB 0050 MDR / IVDR certificates | Not shown as invalid or suspended | Dyson: no impact on maintained certificates; no retrieved withdrawal notice |
| Completed sale | Not shown | Buyer unnamed; no public closing |
| Buyer / acquiring TIC | Unknown | Dyson: "an established TIC organisation" only |
| Short-term services, WIP, certificates | Continuity stated by NSAI management | Dyson short-term paragraph |
| Board orderly-exit decision | 30 July 2026 | Department of Enterprise as quoted 8 August 2026 |
| Testing-division closure / redundancies | Reported separately in the same Irish Times article | Up to 20 redundancies; not itself a CE-certificate revocation |
| NANDO designation for NB 0050 | No public withdrawal or restriction notice retrieved; NSAI still advertises designation | NSAI.ie MDR/IVDR pages; NANDO/SMCS is JavaScript-rendered and did not return a stable printable record on retrieval |
| MDSAP AO recognition | Still listed as recognized on FDA's AO table | FDA table retrieved 24 August 2026; content current as of 19 November 2024 |
| Official client mailbox | medfuture@nsai.ie | Dyson post |
Do not claim:
That NSAI has already sold the medical-device department or transferred NB 0050 designation to a named buyer.
That a competitor comment offering "free" NSAI certificate transfers identifies the acquirer.
That current NSAI NB 0050, ISO 13485, or MDSAP certificates are void because of the LinkedIn post or the 30 July board decision.
That every client must start an MDR Article 58 or IVDR Article 53 transfer now.
Unknowns that still control timing: the buyer; whether any deal closes; whether NB 0050's identification number would travel with a purchaser; whether HPRA/NANDO designation changes; whether MDSAP recognition moves with the department; any planned-cessation date under MDR Article 46(3) / IVDR Article 42(3); and whether industrial action or staff exits actually interrupt billed work.
Are NSAI NB 0050 MDR, IVDR, ISO 13485 and MDSAP Certificates Invalid Today?
No. An announced decision to divest, and a board decision to begin an orderly exit, do not themselves revoke valid certificates.
Stay-and-monitor is the default while certificates remain in force, NSAI continues the work it says it is maintaining, and no HPRA or NANDO restriction, suspension, or withdrawal notice has been published. That default is not a prediction that nothing will change. It is the legal starting point until a named trigger appears.
If a transfer is later required, MDR/IVDR, ISO 13485, and MDSAP do not move on one form. Each pillar has its own statute or program rule.
Stay Versus Transfer: A Trigger-Based Decision Tree for NSAI NB 0050 Clients
Use observable conditions, not headlines.
Default: stay, keep surveillance current, and build a transfer dossier now.
Why stay is the baseline:
Capacity. Starting as a new applicant at another notified body is slow. Our EU notified-body capacity analysis and the generic changing notified bodies guide both treat incoming queues as a planning constraint, not a reason to abandon a still-functioning certificate.
Stated continuity. Dyson said short-term services, work in progress, and maintained certificates are unaffected. Walking away mid-cycle without a signed incoming agreement can leave a gap in surveillance coverage.
Possible successor path. If a named TIC later assumes the department under a real designation and scope, some clients may be able to stay with that successor. That outcome is not confirmed. Do not budget as if portfolio "grandfathering" has already been granted.
Prepare the file now; start a formal transfer only if a trigger below is true.
| Trigger | What it means | Typical vehicle |
|---|---|---|
| Certificate expiry inside about 9–12 months and NSAI will not confirm written recertification scheduling | Do not let the current certificate lapse during a later move | MDR Article 58 / IVDR Article 53 planning; incoming-NB capacity check |
| WIP freeze: technical documentation reviews or substantial-change files already with NSAI have no binding milestones | Continuity of new work is the issue, not today's certificate validity | Written questions to medfuture@nsai.ie; then Article 58 / 53 if the freeze persists |
| Named acquirer is publicly identified and lacks your device codes, IVD class, or acceptable commercial terms | Scope mismatch is a manufacturer-side reason to leave | Article 58 / 53 (and parallel ISO 13485 / MDSAP files) |
| Formal planned-cessation notice to HPRA and manufacturers | This is the Article 46 / IVDR 42 clock, not the LinkedIn post | MDR Article 46(3) / IVDR Article 42(3) |
| NANDO or HPRA publishes restriction, suspension, or withdrawal of NB 0050 | Designation status has changed | MDR Article 46 / IVDR Article 42; see NANDO verification |
| Open major nonconformities or missing audit reports | Blocks a clean ISO 13485 / MDSAP administrative transfer | Close NCs first; otherwise expect a new-client cycle under IAF MD 2 |
Regulatory Transfer Pathways Compared
| Regime | Governing text | Core mechanism | Hard prerequisites |
|---|---|---|---|
| EU MDR | MDR Article 58 | Three-party agreement (manufacturer, incoming NB, and where practicable outgoing NB) | Valid certificates; agreed invalidity date and label cut-off |
| EU IVDR | IVDR Article 53 | Same three-party structure as MDR Article 58 | Do not use IVDR Article 58 (that article is performance studies) |
| ISO 13485 | IAF MD 2:2023 | Documented pre-transfer review by the accepting certification body | Valid, non-suspended accredited certificate; audit history available |
| MDSAP | Official transfer FAQ applying IAF MD 2 principles | Cycle assumption or new cycle | Option 1: valid certification, audited in previous 12 months, good state of compliance |
When Would MDR Article 58 or IVDR Article 53 Three-Party Change Apply to NSAI NB 0050?
A manufacturer-initiated change of notified body for the same device is MDR Article 58 and the matching IVDR Article 53. The 2026 announcement does not, by itself, start that process.
Citation trap. Under MDR, voluntary change is Article 58. Under IVDR, it is Article 53. IVDR Article 58 governs performance studies. MDR Article 53 is not a transfer statute; it covers involvement of notified bodies in conformity assessment (choice of NB and related application rules). Do not copy the on-site conformity-assessment FAQ that points to MDR Article 53 for certificate transfer.
Mandatory terms of the three-party agreement
MDR Article 58(1) and IVDR Article 53(1) require a clearly defined agreement between the manufacturer, the incoming notified body, and, where practicable, the outgoing notified body (NSAI NB 0050). It must cover at least:
| Clause | Statutory content | Operational meaning for NB 0050 |
|---|---|---|
| (a) | Date on which outgoing certificates become invalid | Calendar date NSAI NB 0050 certificates are withdrawn |
| (b) | Date until which the outgoing identification number may appear in information supplied by the manufacturer, including promotional material | How long CE 0050 may remain on labels, IFUs, and promotions |
| (c) | Transfer of documents, including confidentiality aspects and property rights | Technical files, assessment reports, audit history, access terms |
| (d) | Date after which conformity assessment tasks pass to the incoming body | Surveillance handover date |
| (e) | Last serial number or lot number for which the outgoing body is responsible | Last-lot / last-serial cut-off |
Article 58(2) / IVDR Article 53(2) is narrower than it is often paraphrased: the outgoing notified body shall withdraw the certificates it issued for the device on the invalidity date. Document handover sits in paragraph 1(c), not in paragraph 2. The regulations do not add a separate "without unjustified delay" sentence to 58(2).
For how to qualify an incoming body in the abstract, use Changing Notified Bodies: When and How to Transfer. That page is background. It does not cover this NSAI event.
If NSAI Later Ceases Activities, What Does MDR Article 46 Require for Certificate Continuity?
If a deal never closes and NSAI ceases conformity assessment, or HPRA withdraws designation, the continuity statute is MDR Article 46 and the matching IVDR Article 42. Those articles are not triggered merely by a LinkedIn post or a board "orderly exit" decision.
Keep the pathways separate. The draft mistake to avoid is collapsing planned cessation, 10-day manufacturer notice, and withdrawal extensions into one "24-month" clock.
Planned cessation — MDR Article 46(3) / IVDR Article 42(3)
If a notified body decides to cease conformity assessment activities, it must inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible, and in the case of a planned cessation one year before ceasing.
Certificates may remain valid for nine months after cessation if another notified body has confirmed in writing that it will assume responsibilities for the devices covered. The incoming body must complete a full assessment of those devices by the end of that nine-month period before issuing new certificates. After the body has ceased, the designating authority withdraws the designation.
Restriction, suspension, or withdrawal — notice and different validity rules
10-day notice (MDR Article 46(5) / IVDR Article 42(5)): if designation is suspended, restricted, or fully or partially withdrawn, the notified body shall inform concerned manufacturers at the latest within 10 days.
Suspension or restriction (MDR Article 46(8) / IVDR Article 42(8)): certificates remain valid only under the conditions in that paragraph (designating-authority safety confirmation and timeline, or continued monitoring capability / temporary substitute NB). This is not the nine-month cessation rule.
Withdrawal (MDR Article 46(9) / IVDR Article 42(9)): certificates remain valid for nine months if (a) the competent authority of the Member State where the manufacturer has its registered place of business confirms there is no safety issue, and (b) another notified body confirms in writing that it will assume immediate responsibilities and will have completed assessment within twelve months of the withdrawal. That competent authority may extend the provisional validity of the certificates in further three-month steps, which altogether shall not exceed twelve months.
The twelve-month figure is the incoming body's assessment completion condition on withdrawal. The three-month steps extend certificate validity, up to twelve additional months, not a combined "24-month assessment period."
How Do IAF MD 2 and the Official MDSAP Transfer FAQ Apply to NSAI ISO 13485 and MDSAP Certificates?
ISO 13485 under IAF MD 2:2023
Accredited ISO 13485 transfers follow IAF MD 2:2023, Issue 2, Version 2 (Mandatory Document for the Transfer of Accredited Certification of Management Systems), issued 14 June 2023. The introduction states the criteria may also apply to acquisitions of certification bodies.
The International Accreditation Forum ceased operations on 1 January 2026 and was replaced by Global Accreditation Cooperation Incorporated (Global ACI). IAF.nu is now a legacy site. MDSAP's transfer FAQ still points to IAF MD 2, and accredited ISO 13485 bodies still use that text for transfers. It is the operative transfer document, not a claim that IAF itself still runs the MLA.
The accepting body must complete a documented pre-transfer review (MD 2 clause 2.2), covering at least: accredited scope of issuing and accepting bodies; reason for transfer; valid certification at the sites; the initial or most recent recertification reports plus latest surveillance report and outstanding nonconformities; complaints; audit-programme considerations; and current regulatory engagement relevant to the scope.
| Situation | MD 2 consequence |
|---|---|
| Valid, non-suspended accredited certificate | Eligible for transfer review |
| Suspended certification | Not accepted for transfer (clause 2.1.2) |
| Outstanding major nonconformities | Accepting body shall not issue certification until corrections and corrective actions are verified (clause 2.3.1) |
| Outstanding minor nonconformities | Plans for correction and corrective action must be accepted before issue (clause 2.3.1) |
| Required audit reports unavailable, or surveillance/recertification not completed as required | Treat as a new client (clause 2.2.4(v)) |
| Issuing body ceased trading or lost accreditation | Complete transfer within 6 months or certificate expiry, whichever is sooner (clause 2.1.3) |
Background on obtaining ISO 13485, not on this transfer, is in the ISO 13485 certification process. Cost categories (not NSAI transfer prices) are in Cost Overview: What You Are Paying For.
MDSAP AO transfer — official FAQ
NSAI remains listed as a recognized MDSAP auditing organization on FDA's AO availability table (Dublin / NSAI Inc. Nashua; Application Received, Authorized, and Recognition all Yes). That page is marked content current as of 19 November 2024, so it can lag mdsap.global. Re-check the program AO list before asserting current recognition on the day you file.
The official MDSAP transfer FAQ gives two options:
Transfer of the current cycle. If the original certification is still valid, the manufacturer was audited within the previous 12 months, and the manufacturer is in a good state of compliance, apply to a receiving AO. The process follows IAF MD 2 principles. If successful, the receiving AO takes over the cycle at its current stage and issues a new certificate with the same scope and expiration date.
Otherwise, start a new cycle. The new AO must still follow up findings from past MDSAP audits. The manufacturer is requested to share audit history. Regulatory authorities can detect undeclared AO changes.
The FAQ does not define "good state of compliance" as a named Grade 4 / Grade 5 cutoff. High-grade open MDSAP nonconformities are a practical reason a receiving AO will refuse option 1; do not treat a grade number as if the FAQ wrote it.
MDSAP is not a private certificate swap. Health Canada uses MDSAP for Class II, III, and IV licences; an AO change usually means filing the replacement certificate against the licence. FDA, TGA, ANVISA, and MHLW/PMDA each have their own ways of seeing AO assignments. Confirm the current filing channel for each authority you rely on—do not assume a single "eSubmitter plus establishment-registration edit" updates every regulator.
For whether to keep MDSAP at all, see the 2026 MDSAP audit-approach and ROI guide. For audit mechanics, see MDSAP audit preparation and recognized AOs. Those pages list NSAI among AOs; they are not this divestment playbook.
NB 0050 Labels, Packaging, Inventory, Declaration of Conformity and EUDAMED: What Changes Only After a Number-Change Date?
The four-digit number 0050 on the CE mark is NSAI's notified-body identification number. Replacing it is a labelling, DoC, and EUDAMED event timed to the contractual dates in Article 58(1) / Article 53(1)—or to a designation-change notice—not to the LinkedIn post.
| Asset | Until the agreed cut-off | After the agreed cut-off |
|---|---|---|
| Device label / CE mark | CE 0050 | Incoming NB number, on lots after the last-lot / last-serial rule |
| IFU, carton, promotional material | Outgoing number allowed until the Article 58(1)(b) / 53(1)(b) date | Incoming number |
| EU Declaration of Conformity | Cites NSAI NB 0050 and current certificate numbers | Revised DoC under MDR Article 19 / IVDR Article 17 once replacement certificates exist |
| EUDAMED UDI/device record | Linked to the current certificate / NB | Update certificate reference and NB identifiers; see UDI/Device Registration |
| Finished goods already released under CE 0050 | Remain associated with the last serial or lot for which NSAI is responsible | No Article 58 requirement to recall or relabel stock released before that cut-off |
Do not reprint packaging to a new NB number before that body has issued its certificate: the CE mark plus NB number would then identify the wrong body under MDR Article 20. Do not keep applying CE 0050 to new lots after the agreed (b) and (e) dates.
Regulation (EU) 2023/607 Q&A language about legacy devices keeping an outgoing NB number after a surveillance transfer is a different scheme. Do not import those transition labelling rules into this NSAI event.
EUDAMED Public Certificate Search Is Not an NSAI Client Census
A 25 July 2026 public EUDAMED certificate-search extract contained 3,937 records. Five of those rows listed notified-body SRN 0050 (about 0.13%). In that extract, notified-body name and applicable-legislation fields were blank, so SRN 0050 is the only NSAI key. All five rows were recorded as issued.
That figure is a completeness warning, not a count of NSAI clients. As explained in How many MDR and IVDR certificates are registered in EUDAMED, and why is that fewer than the certificates Team-NB says have been issued?, the public certificates module under-counts issued certificates relative to Team-NB survey totals; historical upload is not mandatory until 28 May 2027. The 25 July extract also predates the 30 July 2026 board decision. Do not publish manufacturer names from those five rows, and do not use "five certificates" to downplay the event.
What Implementation Costs Sit Beyond an Incoming Assessment Fee?
Do not treat an incoming notified body's application or assessment quote as the project cost. NSAI publishes an MDR fee list (MRF-1015) on its service pages; that schedule is not a transfer-price list, and this article does not invent euro or dollar totals.
Cost categories that sit outside the incoming assessment fee:
Overlapping surveillance. NSAI (or a successor) still has to be paid to keep current certificates alive while another body onboards the file.
Artwork and IFU tooling. Plate changes, translations, and packaging reprints timed to the Article 58(1)(b) date.
Unusable pre-printed stock. Cartons, pouches, and IFU inserts that cannot be consumed before the last-lot date.
Internal RA/QA and technical-file hours. Incoming bodies often want the file in their format; that is labour, not a line on the NB quote.
Global amendments. Health Canada licence updates, FDA MDSAP/establishment records, TGA, ANVISA, and PMDA filings that follow an AO or certificate change.
Economic-operator notices. Authorized representative, importer, and distributor packs (new DoC, new certificates).
External project support, if used, for gap analysis, NC closure, and transfer-file assembly.
Whether those categories exceed the assessment fee depends on portfolio size, languages, and inventory. There is no defensible single percentage.
NSAI NB 0050 30/60/90-Day Readiness Plan
Days 1–30 — inventory and written questions
List every NSAI certificate: MDR, IVDR, ISO 13485, MDSAP. Capture number, scope, expiry, and next surveillance date.
Archive audit reports, technical-documentation review letters, open NCs, and quality agreements that name NSAI or CE 0050.
Write to medfuture@nsai.ie: confirm upcoming surveillance dates; target dates for WIP reviews; how NSAI will notify clients if a purchaser is named or if a planned-cessation timetable is issued.
Re-open NANDO / SMCS for body 0050 and keep a dated screenshot of designation status.
Days 31–60 — close blockers and map capacity
Drive CAPA to verified closure on any open major NSAI findings. Those block IAF MD 2 issuance.
Check technical documentation against current MDCG expectations so a file is transferable, not just "currently certified."
Measure packaging lead times and on-hand CE 0050 printed stock against a hypothetical last-lot date.
Hold confidential capacity conversations with two or three designated bodies whose NANDO scope matches your codes. Do not sign a premature three-party agreement on rumour.
Days 61–90 — governance without pulling the trigger
Set executive gates tied to observable events: named TIC and scope, Article 46(3)/42(3) notice, NANDO/HPRA status change, or inability to complete WIP.
Draft Article 58 / Article 53 term sheets covering (a)–(e) so legal review is not the long pole later.
Map MDSAP and national filing steps (Canada, FDA, TGA, ANVISA, Japan) if an AO change is later required.
Keep paying for and attending NSAI surveillance unless a trigger says otherwise.
Frequently Asked Questions
Has NSAI already sold its medical-device department and NB 0050 designation to a named buyer?
No. As of 24 August 2026, NSAI has announced a decision to divest the department to an unnamed established TIC organisation. No public closing and no named acquirer appear in the Dyson post, the Department statement quoted by The Irish Times, or NSAI.ie news.
Are NSAI NB 0050 MDR and IVDR certificates invalid today because of the 2026 divestment announcement?
No. Dyson stated there is no impact on maintained certificates. A board orderly-exit decision is not certificate withdrawal. No retrieved HPRA or NANDO notice shows NB 0050 designation withdrawn as of 24 August 2026. Re-check NANDO before you rely on that status.
Should every NSAI NB 0050 client start an MDR Article 58 or IVDR Article 53 transfer now?
No. Stay-and-monitor is the default while certificates remain valid and NSAI continues stated surveillance. Build the transfer file now. Start the three-party process when a trigger in the decision table is actually present.
What is medfuture@nsai.ie and what should manufacturers ask NSAI in writing?
It is the mailbox Dyson opened for correspondence about the announcement and for client tools. Ask, in writing: next surveillance dates; WIP review milestones; how clients will be told if a purchaser is named; whether NSAI intends to issue an Article 46(3) / IVDR 42(3) timetable; and how ISO 13485 and MDSAP will be handled if the department moves.
If I later leave NSAI NB 0050, what must the three-party agreement cover?
MDR Article 58(1) / IVDR Article 53(1): invalidity date; how long CE 0050 may appear in information including promotional material; document transfer (confidentiality and property rights); task-handover date; last serial or lot number. Article 58(2) / 53(2): outgoing NB withdraws certificates on the invalidity date.
Can I transfer NSAI ISO 13485 under IAF MD 2 if I have open major nonconformities?
Not to a new certificate. Clause 2.3.1 prohibits the accepting body from issuing certification until major nonconformities are verified closed. Minor NCs can travel if the corrective-action plan is accepted. Missing audit reports force a new-client path.
Does a LinkedIn comment offering free NSAI certificate transfers mean that commenter is the buyer?
No. That is a commercial pitch. Official transactional news, if it comes, should arrive through NSAI (including medfuture@nsai.ie) and Irish government or HPRA/NANDO channels—not from an unsolicited comment.
How Pure Global Supports Certification Continuity
Pure Global offers independent regulatory, QMS-readiness, and transition project support for manufacturers who need to inventory NSAI certificates, close transfer-blocking nonconformities, and assemble an Article 58 / Article 53 / IAF MD 2 / MDSAP file without treating rumour as a trigger. That work includes medical device QMS consulting, EU MDR consulting, and EU IVDR consulting. To scope a readiness review, contact Pure Global.
Pure Global is not a Notified Body, certification body, or MDSAP auditing organization. It does not issue CE certificates, ISO 13485 certificates, or MDSAP certifications, and it cannot replace NSAI NB 0050 or any incoming body.
Sources
Claire Dyson, NSAI Director of Medical Devices — public LinkedIn post on the medical-device department divestment (retrieved 24 August 2026).
The Irish Times — "National Standards Authority of Ireland plans up to 20 redundancies" (Emmet Malone, 8 August 2026), quoting the Department of Enterprise on the 30 July 2026 orderly-exit decision.
Regulation (EU) 2017/745 (consolidated) — Articles 19, 20, 46 and 58.
Regulation (EU) 2017/746 — Articles 17, 42 and 53 (IVDR Article 58 is performance studies, not NB change).
MDSAP.global FAQ — requirements for transfer of certification.
NANDO / Single Market Compliance Space notified-body list (re-verify live; the application is JavaScript-rendered).
NSAI medical device certification and MDR / IVDR information (retrieved 24 August 2026; no divestment news item on the latest-news listing).
FDA — Auditing Organization Availability to Conduct MDSAP Audits (NSAI listed; page current as of 19 November 2024).
Unite Ireland — NSAI bank-holiday closure announcement statement (2 August 2026); labour-relations context, not a regulatory notice.