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Topic : Type : Briefing

ABHI asked a small sample of member companies to share details regarding the timelines and costs associated with the UK, EU and US regulatory systems. This paper summarises key findings and specific data points.

Regulatory costs can be associated with internal resource, evidence and approval processes. These estimates aim to focus on the direct regulatory costs charged by the regulator (i.e. U.S. Food and Drug Administration (FDA), Approved Body (AB), or Notified Body (NB)) for initial conformity assessment. Clinical data and other remediations such as routine annual maintenance of registration, audits etc. would be additional (unless otherwise specified). 

In such a complex area, there will of course be nuances that cannot be captured by figures alone such as the interlinkages between international systems. 

Key Findings

1.  The US system is lower cost with shorter timelines in comparison to the EU.
   • One large company reported costs being over 700% higher in the EU, and timelines 150% longer.
2. The US system is also predictable.
   • All manufacturers reported entering into the US system knowing with certainty when they would have approval or otherwise (details of FDA targets included in Annex A). All companies however faced significant delays and extensions in the EU system. Timeline predictions to aid business planning and supply chain preparations within the EU system were reported as ‘impossible’.
3. Manufacturers reported the benefits of the ‘pre submission’ offer at the FDA in drastically reducing timelines and uncertainties.
   • Further detail provided in Annex B.
4. The regulation of innovation developed by SMEs within the EU has effectively been put on hold as SME internal resource is entirely focused on transitioning existing product portfolios.
   • All four of the SMEs interviewed shared that they had not yet gone through MDR directly (i.e. with new products, not transitioning existing ones from MDD). Further context for the transition is provided in Annex C. Data points related to the EU system are therefore related to MDD/IVDD recertification under IVDR/MDR.
5. To transfer between Approved Bodies or Notified Bodies, companies estimated a timeline of 2- 3yrs.
6. Explicit timelines for the UKCA system are not yet available given it is currently so inter-linked with EU requirements and pathways.
   • Further context for this is provided in Annex D.

Examples of costs faced in US vs EU systems

Company A – A large In-Vitro Diagnostic (IVD) Manufacturer 

US system: A class I device through 510(k), 14 months and with a price of $22,000 (submission cost; not including clinical study and development costs).

EU System: A class C device through IVDR CE-marking, 22 months with a cost of $160,000+ (renewal and resource cost not included).

Company B – A UK SME Medical Device (MD) Manufacturer, 

US System: A class IIa device, through FDA, cost of £5,000 and take 4 months (124 days).

EU System: A class IIa device, through CE, for an existing product (10yrs on market) transitioning from MDD to MDR, the cost has so far been £35k, and taken 34 months, approval expected after 37 months.

Company C – A UK SME MD Manufacturer

EU System + UKCA: 18 months, between total costs range between £80K and £100k per product family, depending on product classification and complexity. Clinical testing also required outside of this. 

Company D – A UK SME MD Manufacturer

US System: For a single product family of Class I medical devices, process completed in 6 months and costs of c. £100k.

EU System: MDD/MDR transition of all product types started 6 yrs ago, and expected to complete next year. Costs varied, however in 2024 expecting to pay NBs £200k.

Company E - A UK SME MD Manufacturer

EU System: Class I and IIa products, c. £50k per technical file, with a timeline of 12 months once project begins, lead times have varied. In addition, the company faces annual audit fees c. £15k.

Annex A – FDA 510(k) targets and costs 

For 2024, the FDA has a target for giving a decision on a 510(k) of 124 calendar days. It also has a target for decisions for 95% of 510(k) submissions within 90 FDA Days (the no. of calendar days which are when the submission is 'under review').

The FDA reduces costs for a small business (less than $100m gross sales) for a 510(k) from $21,760 to $5,440.

Annex B – Pre Submission offer - US FDA

• Includes a free of charge meeting with the FDA.
• Companies are able to share plans for their 510(k) application where the regulator is able to voice objections.
• Companies are then able to send them a list of questions for written response or an additional 1-hour discussion (offered remotely).

Annex C – Context for EU regulatory transition

• Historically, medical devices have been regulated by two European directives - the Medical Device Directive (MDD) and the In - vitro Diagnostic Directive (IVDD).
• In 2017, the EU then published the Medical Device Regulations (MDR) and Invitro Diagnostics Regulations (IVDR).
• The process of implementation has however been plagued by capacity constraints and implementation challenges, and so the transition between the directives (MDD/IVDD) and regulations (MDR/IVDR) is ongoing.
• The above data points for the EU system, largely represent the time taken to transition existing rather than new/innovative products because that is where the capacity in the system has been required to focus. 

Annex D – Context for links between EU and UK regulatory systems

• As the UK left the European Union before the MDR became law, the UKCA requirements are based on those that were currently in statute - the MDD.
• Therefore, for most of the products certified under UKCA, manufacturers have based their applications on their pre-existing EU MDD certification.
• They will also have used likely used the same organisation, if different legal entity, to do so – for example the UK Approved Body BSI UK)rather than the EU Notified Body (BSI Netherlands.
• Separating out the current timelines and costs between the UK and EU systems is therefore near impossible.