Key EU and US updates this week focused on notified body requirements, vigilance reporting tools, and several high-profile FDA safety/recall communications.

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Commission Implementing Regulation (EU) 2026/977 published (Notified Bodies – Annex VII alignment)

Area: Europe
Source: European Commission / EUR-Lex
Document type: Implementing Regulation

The EU published Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 setting out uniform quality management and procedural requirements for conformity assessment activities performed by notified bodies under MDR and IVDR. The act was published in the Official Journal on 5 May 2026, with date of effect indicated as 25 May 2026 on EUR-Lex.

Reference: Commission Implementing Regulation (EU) 2026/977 of 4 May 2026…

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EU updates MIR 7.3.1 PDF (SB 11154) and clarifies accepted versions from 1 May 2026

Area: Europe
Source: European Commission (DG SANTE)
Document type: Update

The Commission posted an update to the Manufacturer Incident Report (MIR) PDF form (version 7.3.1, SB 11154) and published a list of which MIR 7.3.1 versions are accepted from 1 May 2026. The page states that versions from the December 2025 publication onward remain acceptable (including Dec 2025, Mar 2026, Apr 2026, and May 2026), while versions published prior to December 2025 “can no longer be used.”

Reference: MIR PDF 7.3.1 (update 7 May 2026) – New manufacturer incident report (MIR 7.3.1 PDF form, SB 11154)

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FDA updates pacemaker safety communication linked to Boston Scientific ACCOLADE correction/recall

Area: United States
Source: FDA (CDRH)
Document type: Safety Communication (updated posting)

FDA updated its “Accolade pacemaker devices” safety communication page on 7 May 2026, pointing readers to Boston Scientific’s March 2026 recall/correction information and FDA’s related communication. The page notes the older safety communication content remains available “for reference purposes only.”

Reference: Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication (Update: May 7, 2026)

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FDA issues final guidance on patient-matched guides for orthopedic implants

Area: United States
Source: FDA (CDRH)
Document type: Guidance (final)

FDA posted a final guidance titled “Patient-Matched Guides for Orthopedic Implants” (May 2026). The guidance page states it provides FDA recommendations on information to support premarket submissions for patient-matched guides and reflects current review practices; the page shows content current as of 6 May 2026.

Reference: Patient-Matched Guides for Orthopedic Implants – Guidance for Industry and FDA Staff (May 2026)

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FDA updates Class I recall communication for Intuitive Surgical SureForm 30 Gray Reloads (da Vinci stapling)

Area: United States
Source: FDA (CDRH)
Document type: Recall / Early Alert (updated)

FDA updated its recall communication on 5 May 2026 for Intuitive Surgical 8mm SureForm 30 Gray Reloads, stating the issue has been classified as a Class I recall. The recall page describes reported instances of incomplete staple lines and notes (as of 23 February 2026) four serious injuries and one death associated with the issue.

Reference: Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads