Need of MDR in place of MDD- why it matters

Introduction

There are many regulations in European Union (EU) that govern how medical device manufacturers can produce and supply their products. In Europe, there is MDD (Medical Devices Directive) as well as MDR (Medical Device Regulation). The MDR is the successor of MDD and has been put in place to protect the health and safety of EU citizens. The EUMDR and In Vitro Diagnostic Regulation (IVDR) present the first major changes to the EU medical device regulatory environment in over 20 years. The two regulations replace three existing MDDs. These regulations go into effect on May 26, 2021 for MDR and May 26, 2022 for IVDR and are applicable for all EU member countries.

Need for MDR

MDD is outdated. At the time of MDD creation, apps that patients use to monitor their health was not in place, and Software as a Medical Service (SaMD) was not even a concept back then.

Comparison of MDD and MDR

In general, the contents of both the documents are represented below.

MDR expands the definition of a medical device to include cosmetics and active implantable devices (such as breast implants!) and introduces new regulation for ancillary medicinal products, devices for cleaning or sterilization, reprocessed single-use medical devices, and some devices with no intended medical purpose.

MDR requires a unique device identifier (UDI) for each product, new device classifications, and new requirements for clinical evaluation, clinical investigation and post-market surveillance.

What Triggered the Move to MDR?

There are various factors which influenced the EU to establish the MDR. Some of them are mentioned below.

a) Medical device scandals

b) Varied interpretations of the laws among EU member states

c) Limited ways to monitor medical device regulations

Areas of change

Major

a) Classes of medical device

b) Unique device identification (UDI) system

Moderate

a) Requirements for clinical evaluation, post-market surveillance system, and clinical investigation

b) Classification rules

 Small

a) The person responsible for regulatory compliance

b) Stakeholders in the lifecycle of the medical device

What does MDR brings for manufacturers

a) Easier preparation of the documents and definition of required tests and assessments for the manufacturers

b) More detailed requirements for technical documentation

c) Established requirements for the Quality Management System

d) More strict requirements with the intention to prove the safety of the medical devices for both users and patients