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Who needs a PRRC?

As per the Article 15 of MDR 2017/745 and IVDR 2017/746, and as interpreted by the MDCG Guidance 2019-7, manufacturers are required to have available within their organisation at least one PRRC with proper expertise in the field of medical devices or in vitro medical devices, as applicable, in the European Union. Manufacturers with fewer than 50 employees and an annual turnover and/or annual balance sheet of less than €10 million are permitted to outsource this role to an external provider like S.M.S.

Link to MDCG Guidance 2019-7

As clarified in the guidance above, as S.M.S. are based outside of the EU, we can only provide this service to manufacturers who are also outside of the EU. However, S.M.S. sister company MediReps (see www.medireps.biz) can also offer this service to EU based manufacturers and authorised representatives. S.M.S. can facilitate this process for you, so feel free to get in touch, wherever you are based!

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Person Responsible for Regulatory Compliance (PRRC)

With the Medical Device Regulation – MDR (EU 2017/745) and In Vitro Diagnostic Regulation – IVDR (EU 2017/746), European regulators aim to ensure companies have a regulatory expert – a Person Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting certain specific EU requirements, S.M.S have the expertise to fulfil this role on your behalf, see below for more info or contact us for an informal discussion

Benefits of selecting S.M.S as your P.R.R.C

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