The MDR is the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 5, 2017, it concerns all medical devices with CE marking

The IVDR is the REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017, it concerns all in vitro diagnostic medical devices with CE marking

The MDR replaces the Medical Devices Directive 93/42/EEC and other directives and regulations.

The IVDR replaces Directive 98/79/EC on in vitro diagnostic medical devices.

A regulation is a binding legal act that all EU countries must implement in full. They are directly applicable in all EU member states and take precedence over national law. They supersede other government regulations.

Directives and regulations are two forms of laws that can be enacted by the EU.

Directive ⇨ MDD, IVDD

Directives enter into force upon publication in the Official Journal of the EU and are binding in their entirety. EU member states are required to transpose these into individual national rights within the deadline. How this is implemented within the individual states is left up to them.

Regulation ⇨ MDR, IVDR

A regulation is a binding legal act that all EU countries must implement in full. They are directly applicable in all EU member states and take precedence over national law. They supersede other government regulations.

In other words, there is NO room for interpretation here.

MDR:
https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32017R0745

IVDR:
https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32017R0746

• Stricter rules for the control of medical devices and IVDs
• More careful selection of accreditation institutes
• there should be significantly greater transparency in all areas in the future
• the traceability of the products from the patient to the manufacturing company should be complete
• The safety of patients and users is to be increased

The definitions are given in Article 2 of the MDR and VDR.

“Medical device” means an instrument, apparatus, device, software, implant, reagent, material, or other article that, according to the manufacturer, is intended for human use and is intended, alone or in combination, to serve one or more specific medical purposes.

“In vitro diagnostic medical device” means a medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software, or system, individually or in combination, intended by the manufacturer to be used for the in vitro testing of specimens derived from the human body, including blood and tissue donations, and used solely or principally to provide information regarding one or more of the following

According to Annex VIII – Chapter III of the MDR, medical devices are assigned to four so-called risk classes with regard to their intended purpose according to precisely defined rules:

Class I: external use with low hazard potential(Is, Im, Ir); wheelchairs, dressings, clinical thermometers, reusable surgical instruments, operating theater textiles.

Class IIa: medium risk ⇨ Dental fillings, hearing aids, blood lancets, scalpel blades

Class IIb: high risk ⇨ Ventilators, X-ray equipment, blood bags.

Class III: very high risk ⇨ Hip implants, cardiac catheterization. (No HERENZ products)

IVDs are classified into four classes according to Annex VIII of the IVDR, depending on the importance of the parameters to be investigated:

Class D: Highly critical values such as for transfusion medicine or for determining life-critical and at the same time highly infectious diseases.

Class C: Critical values such as in genetic testing, determining drug levels, infectious diseases, or congenital diseases in fetuses or embryos. Most self-testing (by patients) also falls into this class.

Class B: Less critical parameters such as glucose or leukocytes. Class B is also the “default class” for parameters that do not fall under any of the above rules.

Class A: This class includes non-critical products such as wash solutions or culture media.

The IVDR also distinguishes other types of in vitro diagnostic devices:

Products for near-patient testing – for self-testing and therapy support

The product class is assigned according to the classification rules during conformity assessment.

The assigned product class is indicated on the Declaration of Conformity (DOC). Depending on the product classification, the involvement of a “Notified Body” may be required.

Notified bodies are designated and government-monitored organizations that are commissioned by the manufacturer to accompany and control the conformity assessment of medical devices. For Class 1 products, the manufacturer can self-certify that their product meets the requirements. Notified bodies are mandatory for medical devices from class 1 (s, m, r). The Notified Body of Heinz Herenz Medizinalbedarf is DNV MEDCERT GmbH with the identification number 0482.

The MDR/IVDR distinguishes between the following natural / legal (n/j) economic operators.

Manufacturer ⇨… manufactures a product or reprocesses it as new

Authorized representative ⇨… person n/j established in the Union who has been mandated by a manufacturer established outside the Union … to perform certain tasks … resulting obligations on its behalf and who has accepted this mandate.

Importer ⇨… person n/j established in the Union who places a product from a third country on the Union market.

Distributor ⇨… n/j Person in the supply chain who makes a product available on the market until it is put into service (exception of the manufacturer or importer).

N/J persons combine the MP according to the intended use

N/J Persons who sterilize MP

The obligations of a distributor are set out in Article 14 MDR/IVDR and states that distributors who make a medical device available on the market must exercise due diligence in complying with the MDR/IVDR. The dealers check before they provide the product on the market whether:

• the CE mark is affixed and whether an EU declaration of conformity has been issued
• the product is accompanied by the information provided by the manufacturer in accordance with Article 10(11)
• Whether the MP is labeled according to MDR and the erf. IFU enclosed
• Ob. if applicable, a UDI has been assigned according to
• in case of imported products, the distributor checks if the importer has fulfilled his obligations according to article 13 par.3 (Attention ! If not, one becomes an importer)
• Keep a register of complaints and inform the manufacturer AND the importer, if applicable.

These points are related to:

• Article 16, cases where the manufacturer’s obligations also apply to importers, distributors or other persons
• Article 25(22), Identification within the supply chain
• Article 27(24), Unique product identification system

With the UDI system = Unique Device Identification (product identification number), the EU has introduced an obligation for a worldwide system for uniform product identification and registration of medical devices. Each packaging level has its own UDI.

UDI-DI: Device Identifier => static data, type, no. and expiration date of certificate, BS, Where was the product placed on the market, risk class, ………alle data on the product

UDI-PI: Production Identifier => dynamic data, serial.lot.number-production and expiry date.

The UDI-DI and UDI-PI appear on the label.

The UDI must be machine-readable and, as a rule, must also be printed in plain text on the product and/or packaging. The obligation to label products with the UDI depends on the product class and must be implemented as follows (does not apply to products according to Art. 120 MDR):

Class III and implants: May 2021 Class IIa and IIb: May 2023 Class I: May 2025
For reusable medical devices, where the UDI carrier must be applied directly to the device, the deadlines apply 2 years later in each case, i.e. May 2023, 2025 and 2027, depending on the risk class.

The Basic UDI represents a summary for several variants of a product. Z. For example, cotton swab with wooden stick and with plastic stick. MDR and IVDR define the basic UDI-DI as follows:

The base UDI-DI is the primary identifier of a product model. It is the identification of the product, which is assigned at the level of the unit of use. It is independent of packaging units and at the same time the most important classification feature for records in the UDI database.

The basic UDI-DI must be shown in the relevant certificates, EU declarations of conformity, EUDAMED, TD, PMS, etc. and does not appear on the label or packaging.

Eudamed is the EUropean DAtabankon MEDicalDevices.

It is intended to provide the public with access to all necessary information about the products on the market, the related certificates issued by the Notified Bodies and the economic operators involved. EUDAMED is to include six modules, three of which are already operational.

Registration of actors, Unique Device Identifier UDI, Notified Bodies and certificates, Clinical trials and performance studies, Vigilance, Market surveillance.

Heinz Herenz Medizinalbedarf is registered in the Eudamed database as manufacturer (DE-MF-000018880) and as importer (DE-IM-000008185).