MDR (Medical Device Regulation)

The new Medical Devices Regulation no longer only applies to traditional medical Devices, but also to products “without an intended medical purpose” (Annex XVI – List of product groups in this category).

Among others, products for “body modification” and “beautification” are included, in other words, products which are used by the consumer without a specific medical purpose stated by the manufacturer. Products for liposuction, hair removal and skin resurfacing are also affected.

MDR source:
Article 1: Subject matter and scope

In order to keep pace with technical developments, the classification rules have now been changed. For many manufacturers, this means that their products may be classified in a higher class.

MDR source:
Article 51: Classification

Manufacturers must appoint at least one person who is responsible for regulatory compliance (PRRC). Article 15 of the Medical Devices Regulation (MDR) describes the qualification profile and the tasks of the PRRC in detail.

MDR source:
Article 15: Person responsible for regulatory compliance

The responsibility of the manufacturer with regard to post-market surveillance has been newly defined. The Medical Devices Regulation requires ongoing and systematic documentation which also fulfils the new requirements for Post Market Clinical Follow-Up (PMCF).

MDR-Source:
Article 83-100: Post-market surveillance

The MDR requires a clinical evaluation of existing clinical studies and publications with regard to safe and effective use of the medical Devices. These documents are assessed by<s> </s>our clinical experts within the framework of the conformity assessment procedure.

MDR source:
Article 61: Clinical evaluation
Article 62-80: Clinical investigation

The Medical Devices Regulation does not provide a right of continuance for products with existing certification. This means that medical Devices which are already approved at the present time have to be newly assessed and certified. Medical Devices approved under the MDD may only be placed on the market up to 26 May 2024.

In addition to “harmonised standards” there are now so-called “common specifications (CS)” for design and manufacture of medical Devices (MDR Art. 2,71). These contain detailed information on technical specifications, necessary processes, and evidences to be provided for certain product categories in order to demonstrate compliance with the given safety and performance requirements.  However, their use is voluntary if it can be proven that the solutions adopted ensure a level of safety and performance that are at least equivalent to the state of the art.

MDR Source:
Article 9: Common specifications

Manufacturers of Class III medical Devices have to draw up and publish regular reports regarding their clinical performance (“Summary of safety and clinical performance”, SSCP). This is intended to ensure that members of the public who make use of the Devices can access up to date information about them.  

MDR source:
Article 55: Mechanism for scrutiny of conformity assessments
Article 61: Clinical evaluation
Article 62-80: Clinical investigations

In order to allow the identification and facilitate the traceability of Devices, the Medical Devices Regulation has introduced a system for unique Devices identification (Unique Devices identifier - UDI).

All medical Devices must be provided with a UDI Devices identifier (‘UDI-DI’) specific to a manufacturer and a Device. Following a transitional period dependent on the risk class, these identifiers have to be placed on the label of the Devices or on its packaging so as to be easily readable by man and machine.

Installation of the unique Devices identification system is mandatory for all Devices as from 26 May 2021. However, the label only has to be attached to the Devices or packaging at the end of the transitional period specified for the respective risk class, as shown below:

26 May 2021:
Implantable Devices and Class III Devices

26 May 2023:
Class IIa and IIb Devices

26 May 2025:
Class I Devices

If the products can be re-used, the UID-DI has to be placed directly on the product no later than 2 years after the above deadlines, for example by means of laser engraving (direct marking).

MDR source:
Article 27