Regulatory roles
Where the law requires a responsible person, we can be that person.
Cosmetics and medical device law name people who answer for a product: to the authority, for the file, and after launch. We take on nine roles of this kind for clients, under contract, in the EU, the UK, the US and Portugal. One of them, the outsourced QA Director, rests on a standard rather than a law. Each role below gives its legal basis, where one exists, and the market it covers. Below the list: which of our three companies contracts the work in each market.
In the EU: the EU Responsible Person and the cosmetic safety assessor for cosmetics; the outsourced PRRC, the European Authorised Representative and the outsourced QA Director for devices. The EU Responsible Person, the PRRC and the European Authorised Representative are contracted by CRITICAL CATALYST - Health Consulting, Lda.
In Great Britain: the UK Responsible Person (contracted by CRITICAL CATALYST LTD) and the cosmetic safety assessor for cosmetics.
In the US: the US Agent for cosmetics, under MoCRA. Contracted by CRITICAL CATALYST LLC.
In Portugal: the Responsible Technician for cosmetics, and the outsourced QA Director and the Technical Manager for medical device distribution. The Responsible Technician and the Technical Manager are contracted by CRITICAL CATALYST - Health Consulting, Lda.
The nine roles
Cosmetic products
EU Responsible Person
Market: EU and EEA · Legal basis: Regulation (EC) No 1223/2009, Article 4
Contracted by: CRITICAL CATALYST - Health Consulting, Lda.
We take the role with our address in Portugal, notify the product on the Cosmetic Products Notification Portal (CPNP) and keep the Product Information File available.
UK Responsible Person
Market: Great Britain · Legal basis: Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (UK)
Contracted by: CRITICAL CATALYST LTD
A UK address, notification on SCPN (Submit Cosmetic Product Notification) and the contact point for the Office for Product Safety and Standards (OPSS).
US Agent
Market: US · Legal basis: Modernization of Cosmetics Regulation Act of 2022 (MoCRA, US)
Contracted by: CRITICAL CATALYST LLC
Facility registration and product listing with the US Food and Drug Administration (FDA), with us as the FDA's contact point.
Responsible Technician, Portugal
Market: Portugal · Legal basis: Decreto-Lei n.º 189/2008
Contracted by: CRITICAL CATALYST - Health Consulting, Lda.
The Portuguese technical responsibility role for cosmetics: the contact point with INFARMED, import and export documents, and serious undesirable effects.
Cosmetic safety assessor
Market: EU and Great Britain · Legal basis: Regulation (EC) No 1223/2009
Signs the Cosmetic Product Safety Report (CPSR). The signature is a conclusion, not a conditional opinion.
No cosmetic products roles for this market.
Medical devices (MD) and in vitro diagnostics (IVD)
Outsourced PRRC (Person Responsible for Regulatory Compliance)
Market: EU · Legal basis: Regulation (EU) 2017/745 (MDR), Article 15; Regulation (EU) 2017/746 (IVDR), Article 15
Contracted by: CRITICAL CATALYST - Health Consulting, Lda.
The person Article 15 names for regulatory compliance at a device or IVD manufacturer. Where the manufacturer may use an outsourced PRRC under Article 15, we take the role from outside your company.
European Authorised Representative
Market: EU
Contracted by: CRITICAL CATALYST - Health Consulting, Lda.
Offered only as an extension of the outsourced PRRC service.
Outsourced QA Director
Market: EU and Portugal · Basis: ISO 13485:2016+A11:2021 (a standard, not a law)
Runs your ISO 13485 quality management system and is your interface with INFARMED, with monthly compliance reviews and an annual summary.
Technical Manager, medical device distribution (Portugal)
Market: Portugal · Legal basis: Decreto-Lei n.º 29/2024, Article 27; Good Distribution Practice under Portaria n.º 256/2016
Contracted by: CRITICAL CATALYST - Health Consulting, Lda.
For companies that distribute or import medical devices in Portugal (not for manufacturers): the contact with INFARMED and the notifications it receives.
No medical devices roles for this market.
Who contracts the work
Three companies, one firm. The UK and US companies belong to the Portuguese firm and are its legal presence in those markets.
Portugal and the EU
CRITICAL CATALYST - Health Consulting, Lda., Matosinhos
Contracts EU and Portuguese work, and every market not named below.
United Kingdom
CRITICAL CATALYST LTD, London
Contracts UK clients and UK Responsible Person work.
United States
CRITICAL CATALYST LLC, Sheridan, Wyoming
Contracts US clients and US Agent work.
A role is a legal responsibility, not advice given from the sidelines. When a document or a claim cannot be confirmed, we say so before we sign.
A role is continuing work, not a one-off deliverable. If you also want a standing regulatory partner beside the role, see Ongoing support.
Questions
Who holds the role for us?
You will know before you sign who handles your file.
Can a firm based in Portugal act for us in the UK and the US?
Yes. UK work is contracted by CRITICAL CATALYST LTD, a UK company with a London address. US work is contracted by CRITICAL CATALYST LLC, a US company in Wyoming. Both belong to the Portuguese firm.
We sell cosmetics in the EU, the UK and the US. Is one role enough?
No. Each market has its own role under its own law: the EU Responsible Person, the UK Responsible Person and the US Agent. We can hold all three.
Is a PRRC the same as an EU or UK Responsible Person?
No. The PRRC is a medical device role under Article 15 of the MDR and the IVDR. The EU and UK Responsible Person are cosmetics roles. The names are close; the obligations are not.
In Portuguese both are "Responsável Técnico". Are they the same role?
No. The cosmetics Responsible Technician and the Technical Manager of a device distributor share the Portuguese name but rest on different laws. We name the area every time.
What happens next
Our team replies to every enquiry and asks for the product, the market and the date you are working to.