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Regulatory Compliance Specialists Required Under New European Diagnostic, Medical Device Rules

NEW YORK – The European Commission this week provided additional guidance on new regulations governing medical devices and in vitro diagnostics to require at least one regulatory compliance specialist at each diagnostic firm.

The Medical Device Regulation (MDR) and IVD Regulation (IVDR) are new rules that will go into effect starting next year that will increase oversight of diagnostics in Europe, many of which were self-certified under previous rules.

As part of new guidance, Article 15 of both regulations requires firms to employee at least one specialist to manage regulatory compliance. Such specialists must have a relevant degree and years of experience in regulatory compliance or quality systems management to fill these positions.

The new guidance stipulates that this specialist, called the person responsible for regulatory compliance (PRRC), should be an employee of the organization, and "permanently or continuously" at the company's disposal.

However, it does allow firms with fewer than 50 employees and an annual turnover that doesn't exceed €10 million ($11.3 million) to subcontract these responsibilities to a third party, so long as the individual remains in the EU, if the company in question is based there.

If the company is based outside of the EU, the PRRC should be based in the same country as the firm.

Additionally, according to the new guidance, the PRRC must belong to a different organization from a company's authorized representative. Many countries outside the EU work with authorized representatives to manage their regulatory submissions in the EU.

"There is a clear desire within the regulations for the authorized representative to be adding an additional level of scrutiny and ensure that the supervision and control of the manufacture of devices, and the relevant post-market surveillance and vigilance activities are adequately affected," the guidance states. "If the two roles were conducted by the same person, the additional level of scrutiny would be undermined."

EU regulators continue to publish documents related to the MDR and IVDR. In March, they released a Q&A that addressed the process of seeking clearance for medical devices. Companies are expected to bring their products into line with the MDR and IVDR by May 2020 and May 2022, respectively.