According to Article 15 of the MDR or IVDR, it is required that a company's management designates a person responsible for compliance with the regulatory requirements. This person is also referred to as the "Qualified Person" or Person Responsible for Regulatory Compliance (PRRC). The tasks and qualifications of this role go beyond the previous requirements for the Safety Officer under §30 of the MPG and are partially expanded.
Synonyms: Person Responsible for Regulatory Compliance (PRRC), European Safety Officer for Medical Devices and In-vitro Diagnostics, and Qualified Person* for Medical Devices and In-vitro Diagnostics.
*Note: Although the term "Qualified Person" is used colloquially, it is misleading because it originates from pharmaceutical law and far exceeds the requirements for a Responsible Person under Article 15 of the MDR/IVDR. For this reason, we do NOT use this term here.
Every manufacturer of medical devices or in vitro diagnostics that places these products on the market in the European Union requires, pursuant to Article 15 of the European Medical Devices Regulation (MDR) or the EU Regulation on In Vitro Diagnostics (IVDR), a Responsible Person.
It does not matter in this regard whether the company's registered office is located inside or outside the EU!
Caution: This requirement does not only apply to manufacturers, but also to Authorised Representatives under Article 11. Every manufacturer outside the European Union needs an Authorised Representative with a registered office in the EU to ensure proper approval and registration of their medical devices or in vitro diagnostics. Every EU Authorised Representative must also designate a Responsible Person for Regulatory Compliance.
If your company meets the European SME regulations (Commission Recommendation 2003/361/EC of 6 May 2003) and is classified as a micro-enterprise or small company, you have the option to appoint an external Responsible Person for this important task.
Important: The external Responsible Person must act "permanently and continuously." It is necessary to establish a contractual arrangement and regularly provide evidence to the regulatory authorities, including the Notified Bodies, of both the qualifications and the continuity of the external Responsible Person's activities.
We have excellent contacts with Notified Bodies and authorities in all federal states, ensuring targeted handling of your concerns. With our profound expertise, we are best prepared to save you valuable time in the approval of your medical device or in vitro diagnostic.
For a comprehensive solution, we offer you the opportunity to attend one of our seminars on the topic and bring your knowledge of regulatory requirements up to date. Alternatively, you can familiarize your employees with the role of the Responsible Person according to Article 15 MDR or IVDR.
Our seminars take place in our facilities in Offenbach and Karlsruhe or in-house at your location and are conducted in small groups with a maximum of 6 participants. We place great emphasis on on-site presence to enable intensive exchange between the lecturers and participants. This way, we ensure that you get the most out of the seminar.
The person responsible for regulatory compliance must possess basic and comprehensive qualifications. These are precisely described in Article 15 Paragraph 1 for manufacturers and Paragraph 3 for authorised representatives. The requirements can be summarised as follows:
A university degree in the natural sciences, technical, or medical field AND one year of professional experience in relevant areas such as quality management or regulatory affairs in the medical technology sector
or
Four years of professional experience in relevant areas such as quality management or regulatory affairs in the medical technology sector
Exception: Manufacturers of custom-made devices can demonstrate the required expertise through two years of professional experience in a corresponding specialist field, e.g., master optician.
This is also clearly regulated in the EU regulations on medical devices and in vitro diagnostics. Article 15 Paragraph 3 of the MDR or IVDR describes this as follows:
The Responsible Person for Regulatory Compliance is at least responsible for ensuring that
This means that PRRCs are fundamentally responsible for the conformity of the supplied medical devices, including the documentation - from development through production and release to quality control and post-market data.
The Safety Officer for Medical Devices under §30 of the Medical Devices Act (MPG) was a national requirement that, besides Germany, was only mandated by Austria. In May 2021, the Medical Devices Implementation Act (MPDG) replaced the MPG as the national supplement to the MDR and IVDR. The role of the Safety Officer for Medical Devices is thus no longer relevant.
The Person Responsible for Regulatory Compliance (PRRC) is indeed regarded as the successor to the Safety Officer in Germany. However, the new EU regulations impose significantly higher requirements on this position, and the scope of tasks differs considerably (see above).
No! This conflict of interest is explicitly stated. This means the manufacturer must appoint a Person Responsible for Regulatory Compliance, or PRRC for short. The EU Authorised Representative must, in turn, designate a Responsible Person for Regulatory Compliance. Both persons MUST NOT be identical.
Both the PRRC and the EU Authorised Representative are recorded by name in the EUDAMED database.
Every manufacturer and authorised representative of medical devices has been obliged since May 2022 at the latest to appoint a responsible person, or PRRC for short, if they place medical devices on the market for the first time within the European Union. This also applies to EU authorised representatives.
Important: The Responsible Person must be appointed before the first placing on the market and entered into the EUDAMED database.
Yes! You can appoint multiple Responsible Persons. However, it is advisable to designate only ONE responsible person per product/product group or activity/activity area. If you have any further questions about this, please use our free micro-consulting service.
Yes! If the manufacturer wishes to place the manufactured medical devices or in vitro diagnostics on the market within the European Union, the appointment and registration of the responsible person in the EUDAMED database for this role is mandatory.
Caution: You must designate a different responsible person than the European Authorised Representative appointed by the manufacturer! Both persons MUST NOT be identical.
Yes! You can appoint another or a new responsible person at any time. Please ensure that you not only appoint them internally and in writing, but also register them promptly in the EUDAMED database.
In the European database for medical devices (EUDAMED), the Responsible Person must be recorded by name.
Until EUDAMED is fully functional, there are still partially national databases in EU member states where the Responsible Person must also be registered. In Germany, the PRRC must, in addition to EUDAMED registration, also be entered into the German Medical Devices Information and Database System (DMIDS) of the Federal Institute for Drugs and Medical Devices (BfArM).
We at NEMIUS recommend that you look for a person with specific expertise in your products who also has experience dealing with authorities. It is important to ensure that this person has the required qualifications, including knowledge of the regulatory requirements in Europe and the individual processes.
If there is no suitable person in your company or the position cannot be filled in a timely manner, external resources such as NEMIUS can take on this role under certain conditions. Don't hesitate to contact us! Together, we will find a solution that suits you and your company.
