With the entry into force of the EU Regulation on Medical Devices (MDR), the European legislator has introduced the "Responsible Person" or "Person Responsible for Regulatory Compliance (PRRC)", who is responsible for compliance with the regulatory provisions. This relates primarily to the manufacture of medical devices and their post-market surveillance. The MDR also requires that the Responsible Person be part of the manufacturer's organization and have a certain minimum qualification.
Manufacturers or their authorized representatives and importers, if applicable, must register the name, address and contact details of the Responsible Person in the EUDAMED database. The responsible person must not be the responsible person at the manufacturer and the authorized representative at the same time. In addition, he/she must have a proximity to the manufacturer, i.e. in the case of an EU manufacturer within the EU and in the case of a non-EU manufacturer outside the EU.
Who must designate a Responsible Person according to MDR?
Article 15 of the MDR is decisive for the new requirements for the responsible person. This states that a manufacturer must designate "at least one" responsible person. Consequently, several Responsible Persons can also be appointed. In this case, the manufacturer must plausibly delineate the areas of responsibility of the respective responsible persons and document this in writing.
If a manufacturer is not authorized in the EU, his authorized representative must appoint a responsible person. Importers or distributors of medical devices must designate a Responsible Person if the obligations of a manufacturer apply to them. These aspects are detailed in Article 16 (para. 1) MDR.
What qualification must a Responsible Person have according to MDR?
Article 15 (Para. 1) MDR specifies which qualifications a responsible person must have. According to this, he or she must have the "requisite expertise in the field of medical devices". Fortunately, the MDR specifies this rather vague formulation. According to this, proof must be provided:
- Diploma, certificate or other evidence of formal qualification by completion of a university degree or a course of study recognized as equivalent by the Member State concerned in law, medicine, pharmacy, engineering or other relevant scientific discipline, and at least 1 year of professional experience in regulatory matters or quality management systems related to medical devices; or
- 4 years of professional experience in regulatory matters or quality management systems related to medical devices.
The phrase "or another relevant scientific discipline" invites speculative discussion as to which educational programs might be considered here. In practice, the manufacturer will probably ultimately have to justify his selection and put it in plausible relation to the respective tasks of the responsible person.
What are the tasks of the Responsible Person according to MDR?
Article 15 (para. 3) MDR describes which tasks a Responsible Person has "at least". These are:
- Checking the products for conformity to the existing quality management system before their release,
- Creation or continuous updating of the technical documentation and the EU declaration of conformity,
- Fulfillment of obligations arising from post-market surveillance of medical devices,
- Fulfillment of reporting obligations arising from vigilance requirements,
- Declaration of "safety" of investigational devices for clinical trials.
The vigilance requirements are specified in Articles 87-91, MDR. In particular, they are:
- The reporting of serious incidents and field safety corrective actions,
- the reporting of trends in the frequency or severity of non-serious incidents or expected adverse reactions,
- The analysis of serious incidents and field safety corrective actions,
- Submission of necessary documentation for a risk assessment upon request of a competent authority; and
- The submission of safety instructions.
With regard to clinical trials, the Responsible Person must declare that the device under investigation complies with the essential safety and performance requirements and that all precautions have been taken to protect the health and safety of the subjects (Annex XV, Chapter II, para. 4.1 MDR).
The Responsible Person must comply with the reporting requirements using the EUDAMED database.
How must a responsible person be integrated into the organization of a company according to MDR?
On the question of the organizational integration of the responsible person, Guideline 2019-7 of the Medical Devices Coordination Group of the EU (MDCG) can be consulted. According to this, "organizational integration" is to be interpreted in such a way that responsible persons must be employees of the manufacturer. If there are several manufacturers under the umbrella of a group structure, each individual manufacturer requires at least one responsible person.
Exceptions are micro and small enterprises, i.e. such enterprises which employ less than 50 persons and whose annual turnover or annual balance sheet does not exceed € 10 million. Such manufacturers must have "permanent and permanent recourse" to a Responsible Person. This means that external service providers can completely take over the function of the responsible persons for small and micro enterprises - provided that a corresponding contractual arrangement is in place. This exception also applies to authorized representatives of manufacturers not approved in the EU.
What personal risks are associated with the function of Responsible Person according to MDR?
The function of "Responsible Person" according to MDR may lead to decisions in the sense of product safety and patient protection conflicting with operational or commercial interests of the manufacturer. This area of conflict can lead to an increased personal risk for the responsible person. For this reason, Art. 15 (5) of the MDR stipulates that Responsible Persons must not be disadvantaged in connection with their correct performance of duties. This applies to both employed and external Responsible Persons.
The tasks of a Responsible Person specified by the MDR are far-reaching. The question therefore arises as to what liability risks arise if, for example, patients are harmed and this is attributable to breaches of duty by responsible persons. In the context of product liability, manufacturers are liable for patient injuries due to product defects. In the event of a dispute, the courts will have to clarify whether a responsible person is personally liable and what level of sanctions is associated with this.
The Responsible Person required by the EU Medical Devices Regulation has to perform more tasks and bear a higher level of responsibility than the previous Safety Officer according to §30 of the Medical Devices Act. The Responsible Person has far-reaching responsibility for ensuring compliance with essential regulatory requirements throughout the entire medical device life cycle.
In addition to the interpretation of the qualification requirements and actual qualification or "acquisition" of suitable specialists, both manufacturers and the responsible persons themselves will be confronted with risk considerations. Corresponding legal disputes of a labor and liability nature are pending at the national level.
With regard to the current transition from the Medical Device Directive to the Medical Device Regulation, the MDCG Guidance 2021-25 explains that manufacturers who place their products on the market exclusively in accordance with Art. 120 (3) ("legacy products") do not require a Responsible Person. We recommend to keep up to date with the current status of the Responsible Person and to start with the implementation in your own company in due time. Please contact us if you have any questions on this topic.