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.
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!
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
Not everyone could be your PRRC. The Person Responsible for Regulatory Compliance must meet pre-defined criteria as per Article 15 of the MDR.
A) Hold a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
B) Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
The S.M.S Team are suitably qualified / experienced to fulfil this obligation.
Function of the PRRC
To ensure compliance with MDR or IVDR the PRRC must control the following aspects:
system for collecting and updating clinical data;
post-registration surveillance system;
Activities should be properly documented. Upon request, evidence of this activity shall be provided to Authorities.
Your S.M.S PRRC will be permanently and continuously at the disposal of you and relevant regulatory authorities
Professional yet Affordable
Support with the creation and updating of technical documentation
Registration of your device(s) on EUDAMED
Ongoing support with Competent Authority questions related to your device(s)
Presentation of technical documentation to Competent Authorities upon request
Access to ad-hoc regulatory support as and when required
Access to other services within the S.M.S portfolio