On May 25, 2017, the EU Medical Device Regulation (MDR Regulation (EU) 2017/745) was officially promulgated, with a transition period of three years. It was originally planned to be fully applicable from May 26, 2020. In order to give enterprises more time to adapt to the new regulations and ensure that the products meet the requirements. The European Commission adopted a proposal to extend the transition period on 6 January 2023. According to this proposal, the transition period for high-risk devices will be extended from May 26, 2024 to December 31, 2027; the transition period for low- and medium-risk devices will be extended to December 31, 2028; Class III implantable custom The transition period for equipment will be extended until May 26, 2026.
To understand the chemical requirements of the EU Medical Device Regulation MDR, you must first understand CMR and EDCs substances.
CMR substance CMR is the abbreviation of Carcinogenic carcinogenic substance, Mutagenic gene mutagenic substance and Reprotoxic reproductive toxic substance. Since CMR substances have chronic hazards, they must be strictly controlled and restricted. Thousands of CMR substances have been announced so far, and the number will continue to increase in the future. According to their hazards, they are mainly divided into the following three categories:
CMR: 1A——Proven to have carcinogenic, mutagenic and reproductive toxic effects on humans
CMR: 1B——It has been confirmed by animal experiments that it may cause the above three effects on the human body
CMR: 2——Some literature points out that it may cause the above three effects on the human body. A CMR substance can contain one or more CMR hazard attributes. When it contains multiple CMR hazard attributes, it will be classified according to each hazard attribute ,For example:
Benzene is carcinogenic 1A and teratogenic 1B substances; (Carc. Cat. 1A, Muta. Cat. 1B)
Lead (II) chromate is carcinogenic 1B, reproductive toxicity 1A substances; (Carc. Cat. 1B, Repr. Cat. 1A)
Dibutyltin dichloride is a teratogenic category 2, reproductive toxicity category 1B substance; (Muta. Cat. 2, Repr. Cat. 1B)
Benzo(a)pyrene is carcinogenic 1B, teratogenic 1B, and reproductive toxic 1B; (Carc. Cat. 1B, Muta. Cat. 1B, Repr. Cat. 1B). EDCs substances EDCs substances are Endocrine-Disrupting Chemicals endocrine disrupting chemical substances, which refer to chemical substances that can interfere with human endocrine function from external sources. This man-made chemical can enter the human body or other animals through the food chain (diet) or contact, and affect their reproductive system. They will interfere with the synthesis, release, movement, metabolism, and combination of substances normally secreted in the body, activate or inhibit the endocrine system, and thereby destroy its role in maintaining the stability and regulation of the body.
EU Medical Device Regulation MDR
MDR is the access principle for medical devices to enter the EU market. Its main purpose is to ensure the safety and efficacy of medical device products throughout the life cycle, and to manage medical devices sold in the EU market in a more systematic manner to protect the public. Health and Patient Safety. The introduction of this regulation also means that the previous active medical device directive (AIMD, 90/385/EEC) and passive medical device directive (MDD, 93/42/EEC) will be gradually replaced. Different from the previous regulations, it is required in MDR Article 52 and Chapter II Annex I 10.4.1 that CMR/ECDs substances must be avoided for devices and their components or materials with the following characteristics:
01 Intrusive , and in direct contact with the human body, such as orthopedic implants, ear thermometer test heads, etc.;
02 used to deliver drugs, body fluids or other substances (including gases) to the human body, such as breathing tubes, etc.;
03 used for transportation or storage to be delivered Drugs, body fluids or substances (including gases) to the human body, such as infusion devices, etc.
EU Medical Device Regulation (MDR) Restrictions and Requirements
According to the MDR regulations, it is necessary to confirm medical devices and their components and materials, and avoid the concentration of the following substances exceeding 0.1 (W/W)%: 1) Carcinogenic, mutagenic or reproductive toxic (CMR) substances: category 1A or 1B , according to Table 3.1 of Part 3 of Annex VI of Regulation No 1272/2008 of the European Parliament and of the Council (CLP Regulation). 2) Substances with endocrine disrupting properties (EDCs) that have scientific evidence proving that they may have serious effects on human health, identified in accordance with the procedure specified in Article 59 of Regulation 2 of the European Parliament and of the Council No 1907/2006 (REACH Regulation), or in accordance with Judged by Article 5(3) of Law (3) No 528/2012 of the European Parliament and of the Council. If the concentration of CMR/EDCs substances is higher than 0.1%, the device manufacturer shall indicate the existence of these substances on the device itself and the packaging of each unit, and provide a list including the names of the substances and their concentrations. If the intended use of such a device includes the treatment of children, pregnant or lactating women, and other patient groups considered to be particularly vulnerable to harm from such substances and/or materials, the instructions for use shall state that these patient groups may face residual risk, and appropriate precautions, if applicable.
RoHS-Restriction of the use of certain hazardous substances in electrical and electronic equipment
If the test and evaluation requirements of RoHS, REACH and other directives have been met, do we still need the test results of chemical substances required by MDR? The EU RoHS Directive is a mandatory standard. Controlled electronic and electrical products and related parts must be lower than the requirements of restricted substances. It is a directive that must be paid attention to when exporting electronic medical devices to the EU.
The REACH regulations mainly focus on the following two requirements in medical devices for control and notification (Article 7 (2)): When the concentration of a substance of very high concern (SVHC) is > 0.1% and the total export volume is > 1 ton/year, the substance must be notified to The European Chemicals Agency (ECHA), among other things, may also involve requirements for information transfer along the supply chain. Prohibited and restricted substances (Article 67): For specific use materials or when the product contains controlled prohibited and restricted substances exceeding the limit, the manufacture and use are prohibited.
Packaging and Packaging Waste Directive-Directive 94/62/EC (PPW) Packaging and Packaging Waste Directive (Directive on Packaging and Packaging Waste) mainly stipulates four heavy metals in packaging materials and concentration limits and packaging waste waste recycling. According to Article 22(i) of this law, EU member states must ensure that from June 30, 2001, their packaging or packaging materials cannot contain four heavy metals (cadmium, hexavalent chromium, lead, mercury) and their total concentration. The total should not exceed 100 ppm. The European Union issued Directive 2013/2/EU on 2013.02.08 to revise the Packaging Materials and Packaging Waste Directive (Directive 94/62/EC, PPW). The new directive maintains the same four total requirements for harmful substances in packaging materials: lead, cadmium, mercury, and hexavalent chromium, and is still limited to 100ppm, effective on September 30, 2013. According to the requirements of PPW, the product packaging of the producer must meet the requirements of harmlessness, packaging reuse, recycling of waste packaging materials and other forms of regeneration, and reduction of final disposal. The prepared documents are called packaging materials. Hazard compliance assessment report/verification.
EU charged medical devices must comply with the three regulations of MDR, RoHS and REACH
The compliance requirements of MDR, RoHS and REACH are parallel to each other. Live medical devices placed on the EU market must comply with the requirements of these three regulations, while passive medical devices are not subject to RoHS regulations. Among them, REACH and RoHS regulations are the basis, and for medical devices that comply with the MDR Annex I 10.4.1 specification, CMR/EDCs chemical substance testing must be carried out. In addition, medical devices need to comply with the requirements of MDR regulations not only to meet the requirements of RoHS and REACH regulations, but also to classify each chemical substance based on the manufacture of materials and their risks when selecting an appropriate evaluation method to ensure that medical devices are suitable for The different materials are tested for reasonable substance evaluation.
Post time: Sep-06-2023