Our MedTech news for February 2026 covers further evolution for global device regulation – with new EU harmonised standards, a draft Implementing Act on requirements for Notified Bodies, and proposed MDR/IVDR changes regarding medical device cybersecurity.
MHRA updates related to medical device regulation in Northern Ireland and recognition of CE-marked devices also feature, as well as the latest on Health Canada’s REP process, China’s standards revision plan, and updated UDI requirements from Brazil’s ANVISA. Read on for more…
MedTech news from the EU
New harmonised standards under MDR/IVDR
At the end of January, the EU Commission published new Implementing Decisions amending the existing harmonised standards as per 2021/1182 and 2021/1195 regarding neurosurgical implants, biological evaluation of medical devices, clinical investigation of medical devices for human subjects, sterilisation of health care products, labelling, and other core safety and performance domains.
Once cited, voluntary use of these standards confers presumption of conformity with the MDR/IVDR requirements they cover, reinforcing the role of CEN and CENELEC standards as practical compliance tools. Read more on the standards under MDR here, and IVDR here.
MedTech Europe welcomes draft Implementing Act on requirements for Notified Bodies
The draft Implementing Act addressing Annex VII of the MDR/IVDR aims to ensure more uniform application of requirements for Notified Bodies, with clearer operational provisions and expectations. It marks an important and timely step towards reinforcing the practical functioning of the European regulatory framework for MedTech.
MedTech Europe – having contributed to the process through extensive workshops, structured input, and sustained dialogue with regulators and Notified Bodies, broadly welcomes the draft, framing it as a key short‑term measure to improve predictability, transparency, consistency, and reliability in conformity assessments. Find out more about the draft Implementing Act here.
Team‑NB weighs in on cybersecurity and MDR/IVDR changes
Team‑NB members have endorsed a letter setting out their views on efforts to increase cybersecurity of medical devices in Europe, including proposals to change MDR/IVDR in this area. The letter underlines the importance of strengthening cybersecurity for patient benefit, while ensuring that any regulatory changes remain workable for Notified Bodies and manufacturers. Read the full letter here.
MedTech news from the UK
MHRA clarifies custom-made medical device regulation in Northern Ireland
As of this year, all manufacturers placing custom-made devices on the Northern Irish market must register them with the MHRA within 28 days of the device being made available. This requirement applies regardless of whether the manufacturer is based in Great Britain, Northern Ireland, or the EU, with CE marking being necessary.
GB-based manufacturers must appoint an Authorised Representative based in either the EU or Northern Ireland to manage the registration, and devices placed on the Northern Irish market must follow EU MDR/IVDR post-market surveillance rules. For more on this, see here.
MHRA launches consultation on indefinite recognition of CE-marked devices in Great Britain
Following the July 2025 consultation responses, the MHRA launched a new consultation on 16 February (to run until 10 April this year) that proposes indefinite recognition of CE-marked devices in Great Britain to ensure supply stability, abandoning previous plans for further mandatory UK approval.
Key updates include aligning with EU transition timelines, introducing an international reliance route for higher-risk devices, and enforcing new UK Post-Market Surveillance (PMS) regulations effective since 16 June last year. Find out more about the consultation here.
MedTech news from Canada, China, & Brazil
Health Canada REP process now mandatory for medical devices
Health Canada’s Regulatory Enrolment Process (REP) is a web‑based, structured template system that replaces existing application and fee forms and supports the filing and processing of regulatory information across product lines.
REP captures company, dossier, product, activity, and transaction information in a consistent format, enabling more automated receipt and import of regulatory transactions into Health Canada’s internal repositories. The initiative is part of a broader move towards a common intake process, with efficiency gains expected for both regulators and sponsors once embedded in routine submissions.
For medical devices, voluntary use of the process has been in place since July 2024, with mandatory use now in force for all Class II, III, and IV new licence applications, amendments, and notifications. Read more about the REP here.
China’s NMPA issues standards revisions plan
On 28 January, China’s NMPA issued its “2026 Medical Device Industry Standards Revisions Plan”, covering one mandatory and 79 recommended standards to be established or revised.
The revisions aim to support manufacturers with local type testing and regulatory submissions, and to make Chinese device standards more consistent with relevant international benchmarks.
For global manufacturers, this signals continued convergence at the level of technical standards, even as national submission pathways remain jurisdiction‑specific. Read more on the standards revision plan here.
Brazil’s ANVISA updates UDI requirements for borderline products
Brazil’s medical device regulator ANVISA has issued an update affecting implementation of its Unique Device Identification (UDI) system requirements, including clarifications relevant to certain borderline products.
The update builds on earlier steps under RDC 591/2021, providing additional detail on timelines and expectations for UDI coding and database submissions. As with other markets, UDI is becoming increasingly central to traceability, PMS, and supply‑chain transparency requirements in Brazil. Read more on this here.
That concludes our February 2026 MedTech news roundup. We’ll be back in March with more medical device news and updates.
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