Foreign manufacturers entering the UK and EU
You make a strong device abroad and need a compliant route into Britain and Europe. We become your UK Responsible Person and EU Authorised Representative on one contract.
See how we help UK & EU, under one roof UK & EU market access, under one roof
Reach the market. Stay on it.
The senior regulatory partner that has guided 600+ companies to first time CE, UKCA and FDA approval. UK Responsible Person and EU Authorised Representative, on a single contract.
Newcastle, UK · Cork, Ireland · QA / RA Compliance Partners
- 600+
- companies to first time approval
- 15
- FDA inspections
- 0
- warning letters
- 27+
- years in global QA and RA
- UK + EU
- representation, one contract
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Who we help
Three kinds of manufacturer, one route through
Wherever you are starting from, the goal is the same: a file that passes and a market that stays open.
SMEs and startups chasing CE, MDR or FDA
A first approval can make or break a young company. We build the file right the first time so you are not paying twice or missing your window.
See how we helpEstablished makers facing a deadline
MDR, IVDR and EUDAMED dates are closing in. We bring 27 years of transition experience to keep your devices on the market without a gap.
See how we helpWhat we do
Everything you need to reach and hold the market
One senior team across the full regulatory lifecycle. No handoffs, no juniors learning on your file.
UK Responsible Person
Your registered UK Responsible Person for the MHRA. We hold your file, handle registration and stand as your point of contact in Great Britain.
- MHRA device registration
- UK point of contact
- Vigilance and incident handling
EU Authorised Representative
Your EU Authorised Representative based in Cork. One partner covers both the UK and the EU after Brexit, on a single contract.
- Article 11 EU AR
- EUDAMED registration
- Import and PRRC support
CE and UKCA Marking
Technical files and design dossiers built to pass. We have constructed more than 500 CE files, every one approved.
- Technical documentation
- Notified Body strategy
- Declaration of Conformity
MDR and IVDR Transition
Move legacy devices onto the new regulations before the deadlines bite. Led the $250M Abbott IVDR programme across nine countries.
- Gap analysis to remediation
- Clinical and performance evidence
- Deadline planning
Software and SaMD
Software as a Medical Device handled end to end, from classification and IEC 62304 to clinical evaluation and post market surveillance.
- Classification and risk
- IEC 62304 lifecycle
- Cybersecurity and PMS
Global Market Access
Beyond the UK and EU. FDA 510(k), Health Canada, MDSAP, and routes into Asia and Australia, coordinated from one team.
- FDA 510(k) and QSR
- Health Canada and MDSAP
- Asia and Australia routes
Productised tool
Not sure where you stand? Start with a Gap Assessment.
A fixed fee report on exactly what your technical file needs to pass, powered by our proprietary IVDR Gap Analysis tool. You get a clear list of what is missing, what is at risk and what to fix first. No retainer, no guesswork.
- Fixed fee, fixed scope
- Delivered as a written report
- Built on 500+ approved files
- Straight into a remediation plan
Proof, not promises
The track record behind the work
Worldwide Device Solutions is led by Paul Rowden, who has spent 27 years getting devices and diagnostics onto the market and keeping them there.
IVD · transition
$250M IVDR programme across nine countries
Programme Manager for a global diagnostics leader, steering the IVDR transition across the USA, UK, Ireland, Norway, Germany, China, Japan and South Korea.
$250M programme value
Orthopaedics · leadership
Interim VP of QA and RA for a global implant maker
Stepped in to lead a 27 person quality and regulatory team on a $2.3M budget, holding the line through audits and approvals.
27 person team led
Inspections · record
15 FDA inspections, zero warning letters
Across nearly three decades and 15 FDA site inspections, not a single warning letter. Files that hold up when the regulator is in the room.
0 warning letters
Trusted on devices and diagnostics for
The team
Senior people, not a sales desk
A small group of specialists who have each spent decades in regulatory affairs. Whoever holds your file is the expert, not a coordinator passing it on.
Free download
The 2026 to 2028 Deadline Survival Kit
EUDAMED goes mandatory. MDR and IVDR transition dates land. The MHRA decides on CE recognition. Miss one and your device can fall off the market overnight.
This kit lays out every key date in plain English, what it means for your devices, and the single thing to do before each one. Built from 27 years of getting it right.
- Every MDR, IVDR and EUDAMED date on one timeline
- What each deadline means for your class of device
- A pre deadline checklist you can act on this week
Free download
Get the 2026 to 2028 Deadline Survival Kit
A plain English map of every MDR, IVDR and EUDAMED date, and what to do before each one. Sent straight to your inbox.
No spam. Unsubscribe in one click. We never share your details.
Insights
Plain English reads on a complex market
EU MDR / IVDR
EUDAMED goes mandatory in 2026
The EU device database stops being optional from November 2026. A plain English look at who has to register, when, and what to do now.
10 Jun 2026 Market accessUK Rep and EU Rep under one roof
After Brexit you need a UK Responsible Person and an EU Authorised Representative. Running them as two contracts costs you more than money.
4 Jun 2026 IVDRIVDR gap assessment: where you stand
Most IVD manufacturers think they are further along than they are. A Gap Assessment tells you the truth before a Notified Body does.
28 May 2026
Latest from LinkedIn
Follow Paul for plain English regulatory insight
Paul posts on the deadlines that matter, the gaps that catch manufacturers out, and what is actually changing across MDR, IVDR, EUDAMED and the UK. New thinking most weeks, straight from 27 years on the front line.