Avoca Terrigal S.R.L. is an independent provider of European Union (EU) Authorised Representative services under Article 11 of the Regulation (EU) 2017/745 - Medical Devices Regulations (MDR). Avoca Terrigal S.R.L. is registered in the EUDAMED database under Actor ID/SRN RO-AR-000034301.
Medical device manufacturers without a registered place of business in the EU who wish to obtain CE marking approval and place their products on the EU market are required to appoint an EU Authorized Representative registered in one of the EU member states. An EU Authorised Representative serves as the liaison and contact point with the various National Competent Authorities of the EU member states and can support in regulatory matters.
Avoca Terrigal S.R.L. does not distribute or sell medical devices. Distributors of medical devices have commercial interests which may conflict with manufacturer’s regulatory obligations, for example product labelling, warehouse conditions, and information supplied to customers. We believe that only an independent EU Authorised Representative can best serve the interests of non-EU manufacturers.
Avoca Terrigal S.R.L. works in partnership with Australian-based Market Access (AUS) Pty Ltd which has been providing regulatory and quality management consulting for medical device companies since 2010 (note the unmistakable Australian connection in our name).