How can I be a responsible person

A "Person Responsible for Regulatory Compliance" (PRRC) demand both the MDR and the IVDR.

Some also speak of one "Article 15 Person" (according to the corresponding articles in the two EU regulations) or by the "Qualified Person".

In German there are the terms of person responsible for compliance with regulatory requirements " (short: responsible person) or the qualified or competent person.

The "Person Responsible for Regulatory Compliance" PRRC has similarities with the safety officer, but is not congruent with them.

Find out which tasks the PRRC carries out, which responsibilities it has to assume and which competencies are mandatory. So can you Avoid administrative fines of up to EUR 30,000.

1. Regulatory requirements under the PRRC

a) MDR and IVDR

motivation

It was important to the authors of the "Medical Device Regulation" MDR that there is a "person responsible for regulatory compliance", among other things, to improve manufacturing and the market surveillance and reporting system. You write in the preamble:

It should be ensured that supervision and control of the manufacture of and the post-market surveillance and vigilance activities of medical devices are carried out within the manufacturer’s organization by a person responsible for regulatory compliance who fulfills minimum conditions of qualification.

responsible person“Is mandatory

Logically, the MDR calls for such a thing in Article 15 "Person responsible for regulatory compliance". The IVDR makes the almost identical requirement, also in Article 15. Both Articles stipulate:

The EU has published a "Guidance on Article 15 MDR-IVDR Person responsible for Regulatory Compliance". A revision of this guidance is planned for 2020:

Registration is compulsory

Article 31 in conjunction with Annex VI, Part 1, Paragraph 1. and 1.4 state that "the Manufacturer or yours, if applicable Authorized representative and, if applicable, the Importers the "Name, address and contact details of the person (s) responsible for regulatory compliance in accordance with Article 15." have to register in EUDAMED.

Please note: The requirement for an "Article 15 person" does not only affect the manufacturer, but also the importers and authorized representatives, if applicable!

In the guidance document mentioned above, the EU emphasizes that it is responsible for compliance with the regulatory requirements responsible person NOT at the same time the EU representative (authorized representative).

The responsible person must be close to the manufacturer, i.e. with an EU manufacturer in the EU, with a non-EU manufacturer outside the EU.

There are no transition periods

The general opinion is that the PRRC must be implemented as of May 25th, 2020. This also applies if the manufacturer still brings his products onto the market under the guidelines (MDD) during the transition period. The NAKI writes about it.

A person responsible for compliance with the regulatory provisions (PRRC) must be present in accordance with Art. 15 MDR. However, your registration in EUDAMED is unnecessary as long as EUDAMED is not yet available.

NAKI, UG1

In many countries such as Germany, the safety officer is already required by law. He or she must be reported to DIMDI.

For IVD manufacturers, the PRRC must be implemented with the IVDR valid from May 26th, 2022.

b) National law and penalties

In Germany, the Medical Device Implementation Act MPDG applies from the time the MDR comes into force. It puts no additional requirements beyond the MDR to the “person responsible for regulatory compliance”.

However, the MPDG determines in §94 (3) 5. + 6 the amount of the fine (up to "thirty thousand" (sic!) Euros). This can be due if:

"A) contrary to Article 15 paragraph 1 in his organization does not have a person or not a qualified person who is responsible for compliance with the regulatory provisions,

b) in contravention of Article 15 (2), cannot have permanent and permanent recourse to a qualified person who is responsible for compliance with the regulatory provisions,

c) in contravention of Article 15 (6), cannot continuously and permanently fall back on a qualified person who is responsible for compliance with the regulatory provisions "

MPDG §61 (draft)

The MPDG has abolished the role of the safety officer and retained that of the medical device advisor.

2. Duties and responsibilities of the qualified person

a) responsibilities

According to the MDR and IVDR, they are Qualified Persons responsible (!) that the following is ensured:

  1. Medical device conformity is checked in accordance with the QM system (before its delivery) (Article 10 (9)).
  2. Technical Documentation is kept up to date (Article 10 (4) and (6)).
  3. Market surveillance is carried out in accordance with the EU directives (Article 10 (10)).
  4. Reporting requirements are compliant with the EU directives (Article 10 (13)).
  5. In the case of "Investigational Devices", the declaration according to Annex XV, Chapter 2 is issued.

This list also lists the references to Article 10, which the EU names in the "Guidance on Article 15 MDR-IVDR Person responsible for Regulatory Compliance".

Neither the MDR nor the IVDR require that the “persons responsible for regulatory compliance” have to carry out the tasks themselves. You are “only” responsible for completing them. However, the associated responsibility must also lead to a disciplinary influence.

b) Comparison with the safety officer

30 MPG (paragraph 4) requires the safety officer:

The safety officer for medical devices has to collect and evaluate reports that have become known about risks in medical devices and to coordinate the necessary measures. He is responsible for the fulfillment of notification obligations, insofar as they concern medical device risks.

The tasks and responsibilities of a safety officer and a Qualified person are therefore not identical:

c) Liability of the Qualified Person

As a rule, the person responsible is not personally liable in cases of simple negligence. In the event of gross negligence, the manufacturer can take recourse against its employees.

A limitation of liability or an indemnity agreement can be included in the employment contract with the Qualified Person.

In the case of gross negligence and willful misconduct, such an exclusion is neither sensible nor possible. In addition, there is a risk of criminal prosecution.

The responsible persons must not be disadvantaged because of their duties.

Additional information

Read our detailed article on employee liability here.

3. Competencies

a) Competency requirements

The guidelines require that the competencies of the Qualified Persons is proven. There are two variants for this proof:

  1. University degree or recognized degree in law, medicine, pharmacy, engineering or another relevant scientific discipline AND at least one year of professional experience in the areas of quality management or regulatory affairs. This professional experience must relate to medical devices.
  2. Four years of professional experience in the areas of quality management or regulatory affairs. This professional experience must relate to medical devices

For manufacturers of custom-made products, the EU regulations allow proof to be provided with only two years of professional experience.

b) Requirements for evidence

The degrees must be clearly documented. In terms of professional experience, manufacturers should be able to provide one or more of the following evidence:

  • employment contractwhich shows that and since when the person has been working in the area of ​​regulatory affairs or quality management
  • organization chartthat shows this role
  • Training certificates on the topics of quality management, medical device law, market surveillance, risk management, reporting
  • records such as audit reports and document releases
  • report the person at DIMDI as a safety officer

Please note that in addition to the requirements of the MDR, those of ISO 13485 must also be met, which has been focusing even more on competence since the 2016 version.

c) Comparison with the competencies of safety officers

The evidence required by the safety officer differs from those of the in the following points Qualified person:

  • Law is not one of the recognized university degrees.
  • Regardless of a degree, at least two years of professional experience are required.
  • The professional experience relates to the somewhat narrower defined area of ​​responsibility of the Medical Devices Act. Professional experience in quality management also counts for the EU directives.

External "Qualified Person"?

Manufacturers must have this "Person Responsible for Regulatory Compliance", within your organization to have. The MDR allows exceptions for micro and small businesses. But even in these cases they have to "To be able to rely on such a person permanently and constantly." In the "Guidance on Article 15 MDR-IVDR Person responsible for Regulatory Compliance", the EU makes it clear that this access must be contractually regulated.

Small and small organizations are allowed to use external persons. You are exempt from the obligation to hire a “person responsible for regulatory compliance” yourself.

The EU defines what a small or very small organization is in Directive 2003/361 / EC: This includes companies with fewer than 50 employees and an annual balance sheet of a maximum of EUR 10 million.

5. Summary

The requirements for the responsible persons differ according to the type and size of the economic operator or the role.

 Large corporationsSmall businessMicro businessCustom builderAuthorized representative
Employee ≥ 50 < 50 < 10
Annual sales > € 10 million ≤ € 10 million ≤ € 2 million
Internal / external possible Internal VP access to
a VP
access to
a VP
Access to a VP access to
a VP
qualification University certificate + 1 year QM / RA professional experience University certificate + 1 year QM / RA professional experience University certificate + 1 year QM / RA professional experience University certificate + 1 year QM / RA professional experience
or 4 years of QM / RA professional experience 4 years of QM / RA professional experience 4 years QM / RA professional experience 2 years of manufacturing work experience 4 years of QM / RA professional experience
Disadvantage No No No No

With the “persons responsible for compliance with regulatory requirements”, the MDR and IVDR have introduced a role whose responsibility and importance go far beyond that of the safety officer.

Manufacturers are well advised to fill these roles with qualified personnel as quickly as possible

  • to meet the regulatory requirements,
  • to ensure the safety and conformity of their products and
  • avoid painful penalties.

Do you need assistance?

Acquire the necessary skills in the seminar “From safety officer to responsible person” with lead auditor Alexander Thern.

Learn more about this seminar

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