The EU’s new Medical Device Regulation (MDR 2017/745) identifies the key requirements an organisation must look for in the person responsible for regulatory compliance (PRRC). This role is mandatory for any company wishing to access the EU market after 26 May 2020.
The qualifications
Your PRRC must have either:
- 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;
- or, four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.[1]
Size matters
The EU commission identifies micro or small and medium-sized enterprises (SME) as:
- micro: fewer than 10 employees and an annual turnover or balance sheet below €2 million;
- small: fewer than 50 employees and an annual turnover or balance sheet below €10 million;
- medium-sized: fewer than 250 employees and annual turnover below €50 million or balance sheet below €43 million.[2]
Whilst Serge Bernasconi, Chief Executive Officer of MedTech Europe, has said SMEs account for 95% of manufactures operating in the EU,[3] the MDR states that micro or small enterprises are not required to have a PRRC within the company. Instead, you have the option to outsource your PRRC role to an external consultant or compliance service that can allocate a “person permanently and continuously at [your] disposal.”[4] For any other size of organisation, the company must have a PRRC in-house.
The responsibilities
As Article 15 of the MDR defines, the responsibilities of an in-house PRRC should be written into the job description for that role. In addition to this, the PRRC role should be clearly highlighted as a new function within the company’s organisational chart.
At a minimum, the PRRC is responsible for ensuring that:
- the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance obligations are complied with in accordance with Article 10(10);
- the reporting obligations referred to in Articles 87 to 91 are fulfilled;
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.[5]
The PRRC and AR
If you are outside of the EU, your Authorised Representative (AR) in the EU must appoint a PRRC. As with any manufacturer in the EU, the PRRC can be allocated either within the AR or externally—depending on the AR’s size—and the PRRC must have the same qualification criteria as outlined above.
The PRRC and Eudamed
The PRRC details will be uploaded to Eudamed during the registration of economic operators. The EU’s MDR also allows organizations to allocate more than one person as a PRRC and register multiple PRRC members in Eudamed. Your PRRC team may therefore take on specific areas within the role, such as by the product type or compliance requirements. In this instance, Eudamed would require a record of those allocated to the role, a definition of their specific area of responsibility and the way in which they are qualified to do so.
Appointing your PRRC
To appoint a PRRC:
- Create an appointment letter
- Update the job description
- Update the change in your organisational chart
The Tao of Excellence has the experience and expertise to guide your company through its transition to the EU’s MDR. We can support and develop the best strategies for your business, provide gap assessments, specialist training, customised software and process design.
To learn more about our services or to locate the companies that will be offering the PRRC service, visit our website or follow us on LinkedIn, Twitter, Instagram or Facebook to stay up-to-date with the PRRC discussion, the latest industry news, specialist training and events.
Deepa Rajagopalan
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[1] EU Commission, Medical Device Regulation 2017/745, Article 15: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
[1] EU Commission, Micro-, small- and medium-sized enterprises: definition and scope summary: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=LEGISSUM:n26026&from=EN
[1] Serge Bernasconi, Open letter on the implementation and readiness status of the new Medical Device Regulation 745/2017 (MDR), 15 April 2019: https://www.medtecheurope.org/wp-content/uploads/2019/04/MedTech-Europe_VP-Katainen_MDR-implementation-status_15-April-2019.pdf
[1] EU Commission, Medical Device Regulation 2017/745, Article 15: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
[1] Ibid.
