PRRC service
External PRRC
For certain companies, the position of PRRC (Person Responsible for Regulatory Compliance) may be outsourced.
The requirements are defined in Article 15 of the Regulations and 2003/361/EC.
We offer services as an external Responsible Person (PRRC)!
Feel free to contact us and let us discuss how this role can be implemented in your company.
As an external PRRC, we can actively execute the tasks described in Article 15 in your company.
You execute the tasks specified in Article 15 – we provide surveillance activities and fulfill the responsibilities. This approach reduces costs and is perfectly acceptable!
As an external PRRC, we can train your employees to take on this role themselves after a while.
Organizational project preparation
Software tools:
We use software to keep track of our projects. So, the first thing we do is set up a new project.
Software tools:
We record project efforts down to the second using software. Therefore, a new project is first created in the time tracking system.
Quality management:
As part of our quality management system, competent personnel are assigned to your project.
Operational project preparation
Project management:
Detailed planning of required project results
Project risk management:
Analysis of potential project risks with definition of measures
Customer communication:
Definition of suitable communication channels and contact persons
Quality management:
Obtaining necessary input information and documents
Project implementation
Quality management:
Internal kick-off meeting
Quality management:
Processing of the project in defined work packages
Quality management:
The results of the work packages are subject to internal quality control
External review
Customer communication:
Review of project results by our client
Quality management:
Improvement of project results, if necessary
Service release
Quality management:
Release of final project results
Customer communication:
Provision of final project results to our client
Project completion
Quality management:
Archiving of project results
Data protection:
Deletion of input documents and information
Software tools:
Archiving of the project in our project management tool
Software tools:
Archiving of the project in our time recording tool
If you have any questions or want to book a service, feel free to contact us!
Further down the page, you will find an overview of relevant content. There you can find general information on the topic.
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Further down the page, you will find an overview of relevant content. There you can find general information on the topic of the ‘PRRC’ according to the Regulations.
Feel free to also take a look at our blog posts on this topic!
Table of Contents
What is the 'PRRC'?
Regulations (EU) 2017/745 and (EU) 2017/746, i.e. MDR and IVDR, set out clear requirements for economic operators and their responsibilities in various sections.
The economic operator with the most extensive requirements is, understandably, the manufacturer of medical devices or IVDs. Their devices are intended to help patients, but at the same time they can also cause them harm.
Article 15 of the regulations describes a role that is intended to ensure that every manufacturer understands how to behave in the strictly regulated area of the regulations. Sufficient knowledge of the regulatory requirements is necessary for this understanding. For the purposes of the regulations, this knowledge is deemed to have been acquired if the manufacturer can demonstrate expertise in one of the following ways:
- 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;
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
For manufacturers of custom-made devices, two years of professional experience in a relevant manufacturing area is sufficient.
Whether these formal requirements are really sufficient to enable the PRRC to fulfil its role competently remains to be seen. What is important is that the PRRC should be able to understand the regulatory requirements of the regulations, as these define the rules that every manufacturer must comply with.
Which tasks does the PRRC have?
The person responsible for regulatory compliance shall at least be 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;
- the reporting obligations are fulfilled;
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued [MDR only];
- in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued [IVDR only].
How to outsource the PRRC?
In any case, outsourced activities should be managed through your purchasing process. This also includes the role of the PRRC. This ensures that requirements from your purchasing regarding the selection and approval of suppliers are adhered to.
You can appoint the PRRC externally if you meet the requirements of 2003/361/EC regarding the definition of a micro or small enterprise. These are as follows:
- Within the category of SMEs, a small enterprise is defined as an enterprise that employs fewer than 50
people and whose annual turnover or annual balance sheet total does not exceed EUR 10 million. - Within the SME category, a micro-enterprise is defined as an enterprise that employs fewer than 10
people and whose annual turnover or annual balance sheet total does not exceed EUR 2 million.
When appointing an external PRRC, you should, as with internal appointments, make clear specifications regarding responsibility and qualifications. In the case of an external PRRC, appropriate communication channels should also be taken into account or established within the QMS to enable efficient cooperation.
Broadly speaking, the following points should therefore be fulfilled:
- Control via the purchasing process
- Appointment as PRRC
- Implementation of the PRRC role in the QMS
Collaboration with an external PRRC
The nature of the collaboration can vary greatly. Being responsible does not mean carrying out all activities yourself. In many companies, the PRRC is also responsible when the position is filled internally, but the operational implementation is the responsibility of other individuals or departments.
This can also be the case with an external PRRC. However, companies that outsource this role often do not have the necessary human resources to carry out the operational activities.
In these cases, an external PRRC provides active and energetic support in the implementation.
Why choose us?
Trust
Trust is one of our most important values. That is why we attach great importance to the security of your data and exchange them with you only via secure servers in Germany.
Customer satisfaction
Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!
Reliability
Do you have to solve a critical issue at short notice? Together we can do this - if necessary, even with a night shift. Because we are always available for our customers.
PRRC Service under MDR and IVDR
We provide your external responsible person
in accordance with Article 15 of EU 2017/745 and EU 2017/746
Why choose us?
Trust
Trust is one of our most important values. That is why we attach great importance to the security of your data and exchange them with you only via secure servers in Germany.
Customer satisfaction
Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!
Reliability
Do you have to solve a critical issue at short notice? Together we can do this - if necessary, even with a night shift. Because we are always available for our customers.
Good reasons for our cooperation
- We implement the role of the external PRRC pragmatically and efficiently in your company. So that the solution fits you perfectly!
- You decide: Should we, as an external PRRC, build up your staff so that they can take on the role of PRRC themselves as quickly as possible? Or do you want a long-term cooperation?
- Through external PRRCs, you have access to extensive regulatory expertise.
- Communication with notified bodies or authorities is no problem for us, even in the event of a crisis.
Regulatory requirements are the rules of the game in medical technology. We are the right partner for your success!
Our Services
thinqbetter provided external responsible persons for medical devices and IVDs.
We can carry out the tasks described in Article 15 in your company as an external PRRC.
You perform the tasks on Article 15 - we monitor. This way saves you effort and is permissible!
As an external PRRC, we can train your staff to take on this role themselves in parallel with the tasks.
What does PRRC mean?
The abbreviation PRRC stands for “Person Responsible for Regulatory Compliance” – the English-language term for “person responsible for regulatory compliance”. The abbreviation is simply due to the fact that the German and English terms are long and extremely impractical in everyday language use. Other terms are Responsible Person or Qualified Person.
The Qualified Person is modelled on the pharmaceutical sector, as a similar role has existed there for some time. However, this term is therefore imprecise in relation to medical devices.
Nevertheless: All these terms or abbreviations refer to the person according to Article 15 of the MDR or IVDR.
What are the tasks of a PRRC?
The tasks are set out in detail in Article 15. We have provided an overview of this in a our blog posts – This also describes a possible implementation for each task.
Being responsible for a task does not necessarily mean carrying out the task yourself!
So it is up to you how the role of the PRRC should be implemented in the company: Does the PRRC carry out all tasks itself or should it only supervise the implementation?
How does the cooperation work?
First, we discuss in a free e-meeting or telephone call how you envisage working with us as a PRRC. Ideally, this discussion will already determine how you envisage the implementation of the PRRC role. We will be on hand to advise you and work with you to find an individual and sensible solution. At this point, we will also talk about expected expenses.
We then draw up two contracts: An offer for settlement and a contract for appointment as PRRC. After both parties have signed the contracts, the cooperation can start as planned.
You can either do the registration in DMIDS / EUDAMED yourself or we can do it for you.
From now on, the responsible person provided by us can work at your company as agreed. The exact procedure is based on your wishes and the regulatory requirements.
Trust
Trust is one of our most important values. That is why we attach great importance to the security of your data and exchange them with you only via secure servers in Germany.
Customer satisfaction
Your satisfaction is our highest goal in all projects. A project is only successful for us if you are satisfied!
Reliability
Do you have to solve a critical issue at short notice? Together we can do this - if necessary, even with a night shift. Because we are always available for our customers.
We very much look forward to getting to know you!
Detailed information on the handling of user data can be found in our privacy policy
- +49 40 604 2992 - 0
- info@thinqbetter.com
