Regulatory Compliance Roles & Legal Representation

The Legal Manufacturer takes on the full Article 10 obligations under MDR/IVDR: responsibility for design, manufacturing oversight, technical documentation, conformity assessment, post-market surveillance, and vigilance reporting. This requires an ISO 13485-certified QMS. The EU REP (Article 11) represents a non-EU manufacturer in the EU but does not take on the manufacturer's full obligations. The manufacturer retains overall responsibility; the EU REP serves as the EU contact point for authorities and keeps certain documentation accessible. The right choice depends on whether you need someone to carry the manufacturer's obligations (Legal Manufacturer) or simply need EU representation (EC REP).

In practice, yes, and there are good reasons to consolidate. When the MAH, the QPPV, the QP, the RP, and the Stufenplanbeauftragter all sit within the same organisation, the compliance system is integrated rather than stitched together across multiple providers. We operate our own licences (MAH, MIA) and certified infrastructure in Germany, the UK/Ireland, and Switzerland. That said, we take on each role based on a proper assessment of the product, the regulatory landscape, and the client's own capabilities. Not every engagement requires every role.

We provide local QPPVs and pharmacovigilance national contact persons directly in Germany, the UK, Switzerland, and Austria. For all other EU and CEE countries, we provide these through regulanet® partners. You have one contract with regenold and one point of contact. We coordinate the appointments, manage the reporting lines to the EU QPPV, and ensure compliance across all markets.

Under the EU Clinical Trials Regulation, the sponsor is the legal entity responsible for the trial. When we act as sponsor, we submit the CTA via CTIS under our name, arrange trial insurance and indemnity, report SUSARs to EudraVigilance, ensure GCP compliance at all sites, and correspond with national competent authorities. The client retains scientific oversight and funds the trial. This is not the same as a CRO, which performs delegated tasks without carrying the ultimate legal responsibility.

Yes. We regularly act as interim MAH for companies that are setting up their own EU presence. We hold the MA, operate the compliance infrastructure, and transfer the authorisation when the client is ready. In Switzerland, our entity can apply for the MA, hold it, manage Swissmedic inspections, and execute the transfer. The same applies in the EU and UK.

Yes. We provide Drug Information Officer services in Germany directly and in most other EU member states through regulanet® partners. The client has one contract and one contact point. This is particularly relevant for companies launching across multiple EU markets simultaneously.

Yes, we can hold MAs in both the UK and Switzerland. We are also currently developing MAH holding capabilities in Southeast Asian markets through regulanet® members. This is an emerging service. Contact us for the current status and available markets.