Trustfall Articles
The upcoming ISO 9001:2026 standard (anticipated release in September 2026) updates the 2015 version by focusing on modern business needs, including enhanced risk management, sustainability, digital transformation, and ethics.
MDSAP and the UK Medical Device Market:
What could change?
As the UK moves towards greater international regulatory reliance, including recognition of MDSAP certificates, manufacturers should review what this means for thier UK regulatory strategy
KEY AREAS TO CONSIDER
QMS
Map gaps between MDSAP, ISO 13485 and UK specific Requirements
PMS & Vigilance
Build in the UK's Enhanced Post-Market surveilance duties
Technical Documentation
MDSAP does not replace clinical evidence or risk management
MHRA Registration
Registration and UK Responsible Person obligations remain
Labelling & Strategy
Review UKRP, Importer Details and your CE/UKCA approach
Conformity Assessment
Less duplication via recognition or an abriged UK route
SO 13485 Training
Process-based.
Company-specific.
Mapped onto your actual processes, not a generic flowchart
Your procedures and product as the worked examples
Competence you can evidence under Clause 6.2
Gaps found in training, not in the audit
In-house or online · Delivered across design, production, regulatory and management teams
Most ISO 13485 training courses hand you a copy of the standard, walk through the clauses in order, and send you home with a certificate. Then you return to your own QMS and nothing quite fits.
That's because ISO 13485 isn't a list of clauses to memorise. It's a set of processes to run — design controls feeding into risk management, supplier controls feeding into production, CAPA feeding back into the lot.
We can offer training that works the other way round.
Interested? Drop us a message and we will send you an outline of what we can offer.
Everyone's watching the 2026 Medical Devices (Amendment) Regulations
Fewer people are watching the proposed changes to the Medicines and Medical Devices Act 2021 that are being debated in parliament at present, in particular amendment NC94.
MHRA is clear that nothing changes today, UKCA stays, and any regime would be consulted on. But read NC94 alongside other proposals and a direction emerges: a more agile MHRA, and a rebalancing of where assessment responsibility sits.
Tucked into the Government's Health Bill, this amendment does three quiet but significant things:
Procedure. It moves certain medicines and medical devices regulations from the draft affirmative procedure to the negative procedure. Faster to update — and less parliamentary debate before change lands.
Licensing. It gives the Secretary of State powers to attach conditions to medical device licences: safety monitoring, performance evaluation, information sharing. This is the legal foundation for a future GB device licensing regime, where a domestic-route device could need an MHRA licence rather than relying solely on third-party conformity assessment. It also introduces licencing requirements for importers and wholesale dealers.
Exemptions. It permits temporary exemptions from the regulations to protect public health.
You can read the proposed amendments to the Medicines and Medical Devices Act on the UK Parliamentary Bills Website HERE
Do You Need a PRRC, an MD Representative—or Both?
Whether you need a PRRC (Person Responsible for Regulatory Compliance), an EU MDR Authorised Representative, or both, Regulatus can provide these services directly or through our trusted partners.
PRRC
(Person Responsible for Regulatory Compliance)
Required under the EU MDR for manufacturers to oversee regulatory compliance, technical documentation, post-market surveillance, and vigilance.
MD Representative
(EU Authorised Representative)
Required for non-EU manufacturers placing medical devices on the EU market, acting as the official EU contact with Competent Authorities and helping fulfil regulatory obligations.
