12 February 2024

The profession related to the development and management of regulatory activities in the field of Medical Devices and IVDs requires more than ever different skills and approaches, including the legal one. The latter, which is often underestimated compared to the technical-scientific one, is very important to better understand the dynamics of a hybrid role such as Regulatory Affairs.

  1. Sources of law

Sources of law are those acts that a legal system or a given socio-cultural context deems suitable to modify or innovate the system itself, aiming to:

  • build a reference regulatory system that governs the life of a given community;
  • ensure that the rules of the legal system are knowable so that anyone can be aware of them and thus be able to comply with the requirements set out.

The sources of law are based on a hierarchical order:

  • national law: based on state sovereignty;
  • supranational law: based on the regulatory powers of the European Union.

The pyramid of the sources of law is as follows:

  • constitution and constitutional laws àconstitutional sources
  • national and European Union legislation àreinforced primary sources
  • ordinary laws, decree laws, regional laws, EU directives and international treaties àprimary sources
  • administrative regulations àsecondary sources
  • customs and traditions àcustomary sources

Sources are organised according to a hierarchical principle, i.e. the norms contained in higher-ranking sources constrain the productive activity through lower-ranking sources, and lower-ranking sources may not produce norms that conflict with higher-ranking sources, on pain of the illegality of the conflicting norm.

Conflicts could arise between European Union law and national law, which is why the primacy of EU law sources over national sources has been defined, with the only limitation being respect for the Italian Constitution.

The multiplicity of sources within the legal system can give rise to antinomies, i.e. contrasts due to several sources regulating the same subject matter. The resolution of such ambiguities belongs to the interpreter who acts based on different criteria, hierarchical, chronological and competence criteria.

  1. The normative interpretation

A normative statement is characterised by the following features:

  • certain core of meaning: a secure intrinsic concept that may be accompanied by an area of uncertainty, about which interpretation comes to the rescue. The interpreter must use tools defined by the legal system to try to make the utterance as coherent and unambiguous as possible;
  • common sense rule;
  • self-evident fact: a different meaning cannot be attributed.

The attribution of meaning to the rule is provided according to criteria set by law and following the will of the legislator.

Furthermore, normative interpretation can be distinguished according to the method:

  • Literal interpretation: an attempt is made to literally understand the words used according to the connection between them.
  • Teleological interpretation: the intention of the legislator is considered.
    • Declarative interpretation: the words used by the legislator express his thoughts exactly.
    • Extensive interpretation: the words used by the legislator are given a broader meaning than the literal one.
    • Restrictive interpretation: the words used by the legislator are given a narrower meaning.
  • Systematic interpretation: the meaning of the rule depends on knowledge of other laws in connection with each other.
  • Evolutionary interpretation: the rule acquires a different meaning than the one given in the past.

Normative interpretation can be distinguished according to subject matter:

  • Authentic interpretation: binding on all subjects
  • Judicial interpretation: binding only for trials;
  • Doctrinal interpretation: cannot be said to be binding.

A particularly useful concept for practitioners of regulatory activities in the field of Medical Devices is legal liability, which consists of the obligations and liabilities incurred by the performance of acts by individuals, entities, and public administrations. In essence, every legal entity is legally responsible.

Legal liability can be:

  • Objective: placed on the person without any fault or intent on his part;
  • Civil: contractual liability, i.e. breach of contract voluntarily entered into; or non-contractual liability, i.e. through negligence or wilful misconduct causing unjust damage to others;
  • Criminal: commission of an offence;
  • Administrative: those who engage in unlawful conduct in matters subject to public administration control;
  • Accounting: subject to audit by the Court of Audit;
  • Disciplinary: behaviour within a job or profession, following the law or collective agreements.

To market Medical Devices in Europe, numerous legal aspects have to be addressed, largely defined within the MDR Regulation (EU) 2017/745.

Thema, a strategic regulatory consulting company of the Complife Group, combines technical expertise with legal skills for a multidisciplinary and highly specialised approach to accompany Medical Devices on the European market in compliance with regulations.

Find out more about Strategic Regulatory Consulting, CE Certification Support and Italian and European Ministerial Registrations.

Let’s take care beyond the boundaries.