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 helpMedical device regulatory consultants: UK Responsible Person & EU Authorised Representative
Reach the market and stay on it. The senior regulatory partner that has guided 600+ companies to first time CE, UKCA and FDA approval, on a single contract.
Call Paul direct on +44 754 559 5464
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
Next deadline
The next regulatory deadline
-- Days
-- Hours
-- Mins
-- Secs
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.
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, a medical device consultant who has spent 27 years getting devices and diagnostics onto the market and keeping them there.
IVD · transition
$250M IVDR programme across eight 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
SSCP upload in EUDAMED moves to you: the October 2026 change and the February 2027 date
From October 2026 manufacturers, not Notified Bodies, upload the SSCP to EUDAMED. What MDCG 2026-4 changes, who it catches and why 27 February 2027 is the date to plan for.
1 Oct 2026 CE / UKCA markingClass I medical device: what it takes under the MDR and UK rules
What makes a Class I medical device, when Is, Im and Ir need a Notified Body, and the technical file, registration and representative you still need.
25 Sept 2026 EU MDR / IVDRClinical evaluation for medical devices under the EU MDR
Clinical evaluation for medical devices under MDR Article 61 and Annex XIV: the CER, PMCF, equivalence under MDCG 2020-5 and when to run an investigation.
25 Sept 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.