Representation Services

Your regulatory contact in the EU, for medical device manufacturers who need an Authorised Representative or a Person Responsible for Regulatory Compliance.

Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), manufacturers based outside the EU must appoint an Authorised Representative in the EU, and every manufacturer needs access to a Person Responsible for Regulatory Compliance. Altiveno takes on these roles, so you have an EU presence that understands your devices and your obligations.

EU Authorised Representative (AR)

Acting as your EU Authorised Representative under Article 11 of the MDR or IVDR
Keeping your technical documentation and EU declaration of conformity available to the competent authorities
Registration support in EUDAMED
Cooperation with competent authorities on vigilance, field safety corrective actions and requests for information

Person Responsible for Regulatory Compliance (PRRC)

Providing the PRRC role under Article 15 of the MDR or IVDR
Checking conformity of devices before release
Oversight of technical documentation, post-market surveillance and vigilance reporting

Ongoing support

Representation roles run as retainers, so you have a named lead and steady cover rather than a one-off project. We work alongside your quality and regulatory teams, or provide wider support through our Medical Devices services where you need it.