From MPG to MPDG: What Non-EU Medical Device Manufacturers Need to Know About German Medical Device Law

Why the Transition from MPG to MPDG Matters for Non-EU Manufacturers

With the introduction of the EU Medical Device Regulation (MDR – EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR – EU 2017/746), the regulatory framework for medical devices in Europe fundamentally changed.

In Germany, this shift also resulted in a major national legal transition:
the former Medical Devices Act (MPG) was replaced by the Medical Device Law Implementation Act (MPDG) — Germany’s national medical device law.

For manufacturers based outside the European Union, this change is more than a legal formality. While MDR and IVDR apply directly across all EU Member States, key regulatory and enforcement aspects are governed at national level. The MPDG defines how EU requirements are implemented, enforced and supervised specifically in Germany — one of Europe’s largest and most important medical device markets.

This article explains:

• why the MPDG was introduced
• how the transition from MPG to MPDG affects manufacturers
• which German national requirements apply in addition to MDR and IVDR
• why non-EU manufacturers should closely consider the MPDG

Why Was the MPDG Introduced?

Unlike former EU directives, MDR and IVDR are directly applicable EU regulations and do not require transposition into national law. However, they deliberately leave certain areas open for national implementation.

The MPDG was introduced to regulate these areas in Germany, including:

• designation and responsibilities of competent authorities
• enforcement mechanisms and administrative procedures
• penalties and sanctions
• country-specific procedural requirements
• national rules for clinical investigations and vigilance

The MPDG fully replaced the former MPG and was adopted as part of the EU Medical Device Adaptation Act (MPAnpG-EU). Its purpose is to ensure that MDR and IVDR can be effectively enforced and supervised within Germany.

For non-EU manufacturers, this means:
EU compliance does not stop with MDR and IVDR — national laws such as the MPDG can significantly affect regulatory strategy, timelines and audit outcomes.

Transition from MPG to MPDG – Key Dates

The MPDG entered into force on 26 May 2021, the same date the MDR became applicable. At this point, the MPG was formally repealed.

This date marked the beginning of a new regulatory era in Germany:

• MDR and IVDR define the European legal framework
• the MPDG establishes binding national implementation rules
• German authorities received clearly defined enforcement powers

Since then, the MPDG has served as the central national legal basis for medical device regulation in Germany — always in combination with MDR and IVDR.

The MDCG operates through 13 thematic sub-groups, each responsible for specific regulatory domains, including:

• Notified Body Oversight (NBO)
• Clinical Investigation and Evaluation (CIE)
• Market Surveillance & Vigilance (PMSV)
• Borderline and Classification (B&C)
• EUDAMED
• Unique Device Identification (UDI)
• New Technologies (including AI and Software as a Medical Device)
• In Vitro Diagnostics (IVD)
• International Affairs
• Products under Annex XVI

This structure enables targeted, expert-driven guidance for even the most complex regulatory challenges — a major advantage for manufacturers without an established EU regulatory footprint.

MPG vs. MPDG – What Changed?

While some principles of the former MPG were retained, the MPDG introduced significant structural and procedural changes, particularly in areas relevant for manufacturers and clinical sponsors.

Key areas governed by the MPDG include:

• scope and structure of German medical device law
• clinical investigations and performance studies
• authority responsibilities and approval procedures
• penalties and administrative fines
• medical device consultants and safety officers
• labeling and language requirements
• training and instruction obligations
• registration and reporting obligations

Newly Introduced or Fundamentally Revised Topics

• Transition provisions for legacy devices and ongoing clinical investigations
• Dedicated chapters for the German armed forces and civil protection

Updated approval procedures, ethics committee opinions and submissions via
DMIDS (German Medical Device Information and Database System)

For non-EU manufacturers conducting clinical investigations in Germany, MPDG compliance is mandatory, regardless of where the sponsor is located.

MPDG + National Ordinances = The German Regulatory Framework

The MPDG does not stand alone. It is complemented by several German national ordinances that further specify and operationalise MDR requirements.

Key ordinances include:

• MPBetreibV (Medical Devices Operator Ordinance)
  Regulates safe operation, user training and instruction obligations.
• MPAMIV (Medical Devices User Notification and Information Ordinance)
  Defines reporting obligations for incidents and risks during device use.
• Additional ordinances (MPAV, MeMBV, MPDG Fee Ordinance)
  Address product distribution, evaluation of medical methods and authority fees.

These ordinances clarify aspects that MDR only addresses at a high level, such as:

• language requirements (§ 8 MPDG)
• reprocessing of medical devices
• training obligations for software-based devices

Only the combined application of MDR, MPDG and national ordinances creates a complete and enforceable regulatory framework for Germany

Why the MPDG Is Highly Relevant for Non-EU Manufacturers

Manufacturers placing devices on the German market or conducting clinical investigations must align three regulatory layers:

1. EU Regulations – MDR / IVDR
2. German national law – MPDG
3. German national ordinances

This is particularly critical for:

• clinical investigations and ethics committee submissions
• registration and notification obligations
• vigilance and incident reporting systems
• interactions with German competent authorities

A key example is the role of the Person Responsible for Regulatory Compliance (PRRC) under Article 15 MDR. This role is not equivalent to the former German safety officer and cannot be implemented by a simple title change. Incorrect implementation may lead to regulatory non-compliance.