Technical information on the MDR
Medical Devices Regulation
Manufacturers must comply with many regulations if they want to sell medical products on the European or global marketplace. Some substances and materials are banned in certain countries or economic areas such as the EU. There are also many regulations and laws for packaging and transportation. The Medical Devices Regulation (EU) 2017/745 (MDR) stipulates a wide range of requirements. Medical devices may also be affected by the RoHS Directive, the REACH Chemicals Regulation, POPs Regulation, California Proposition 65, regulatory obligations concerning conflict minerals or the SCIP database. EU Supply Chain Due Diligence legislation and the Dodd Frank Act also have an impact on the sector. We are here to help you navigate your way through the regulatory minefield and can help you set up a safe and efficient materials compliance process.
The European Medical Devices Regulation 2017/745/EU (abbreviated to MDR) came into force in May 2021, one year later than scheduled due to the COVID-19 pandemic. Manufacturers of medical devices and other stakeholders in the supply chain now need to satisfy a wide range of materials compliance obligations. Prior to this, the Medical Devices Directive 93/42/EC (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) were applicable. To some degree, the MDR is the next iteration of these statutory provisions; however, it imposes more stringent materials compliance requirements for medical devices in the EU. The new MDR no longer just applies to devices intended for medical use but to cosmetic and other devices, such as contact lenses, aesthetic devices, and implants.
EUDAMED – the European Database on Medical Devices – has been mandatory for all EU Member States since 2011. The scope of the database is now also being expanded as part of MDR implementation. This means data relating to all devices marketed in the EU must be available in EUDAMED, as must data from manufacturers, importers, and distributors. Unique Device Identifiers (UDI numbers) have also been introduced. The aim of using UDIs is to provide transparency along the supply chain and make recall actions easier. A new symbol for labeling medical devices has also been introduced called the “MD” label.
Since May 2021, you are no longer permitted to place devices on the market if they do not comply with the applicable regulations. The substances regulated by the MDR need to be identified and reasons given for why they are present. Otherwise, the technical documentation and the procedure for assessing compliance are invalid. Article 120 Subsection 2 of the MDR stipulates transitional requirements until May 27, 2022, or May 27, 2024. Until this date, attestations of conformity in accordance with the MDD that applied previously are still valid and the devices may be placed on the market, even if they are already subject to MDR obligations. There are also restrictions on selling devices: authorization for devices, which were placed on the market by May 25, 2020, in accordance with the old MDD regulation for medical devices expires on May 27, 2025. Until then, existing stock may still be sold and put into use.
The Notified Bodies that are responsible for certification and assessing compliance of medical devices in accordance with the MDR can conduct spot audits at manufacturers under the terms of the new regulation. Manufacturers are obliged to maintain comprehensive technical documentation and should ensure they have viable communication systems in place. They also need to adapt current contracts to comply with the new statutory MDR requirements and to limit their liability risks. Many firms have underestimated how extremely complex this process is. But help is at hand. Our expert guidance will help you ensure you meet all your MDR compliance obligations. Please don’t hesitate to get in touch with us to find out more about our highly responsive and comprehensive support services.
All components in medical devices must comply with the new safety requirements. This means that CMR substances (carcinogenic, mutagenic, and toxic for reproduction) may not exceed a concentration of 0.1 per cent. The individual materials in the device components are regarded as the point of reference. There are exemptions for higher concentrations of these chemicals for specific areas of application (see Chapter 10.4.2 of the MDR). CMR substances are those that have been proven to be carcinogenic, to cause genetic mutation or endanger reproduction.
The MDR specifically regulates the handling of substances that are described in Annex 1, 10.4 as:
“(a) substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), or
(b) substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the criteria that are relevant to human health amongst the criteria established therein.”
If the following criteria apply to you, devices, or device components and the materials used in them, may not contain a higher concentration of the substances described in the previous paragraph of 0.1% weight by weight:
- They are invasive and come into direct contact with the human body.
- They administer or transport from the body (repeatedly) medicines, body fluids or other substances, including gases.
- They transport or store medicines, body fluids or other substances, including gases, that are administered (repeatedly) to the body.
Under the MDR, manufacturers of medical devices already need to ensure that their articles comply with certain conditions, as well as specific safety and performance conditions, as described in Annex I. This also applies to substance requirements. If they fail to do this, they risk being prohibited from placing their articles on the market. Manufacturers can only obtain a valid CE marking for their articles following an EU Declaration of Conformity if they satisfy all the rules correctly. If you are unsure whether the MDR applies to your devices or materials, we’re here to help. Just get in touch and we’ll help you determine whether you need to act. If the answer is yes, we’ll also help you decide what you need to do next.
Not all manufacturers of medical devices are fully prepared to comply with the stringent materials compliance requirements stipulated under the European Medical Devices Regulation (MDR), which now includes new mechanisms and communications procedures between customers and suppliers.
The general safety and performance requirements stated in Annex I of the Medical Devices Regulation (MDR) (see Chapter II, 10.4 Substances) cover the types of substances permitted or prohibited in articles. The MDR stipulates that technical documentation is mandatory (see Annex II, 4. General Safety and Performance Requirements).
A different procedure for assessing compliance is stipulated, depending on which risk class a device or an article is assigned to. For instance, a new risk class of “lr” has been established for reusable surgical instruments. A “notified body” must be involved for devices in risk classes IIa, IIb and III and for some devices in Class I. There is also a new mechanism for scrutiny of some high-risk devices in classes IIB and III, which also involves an independent panel of experts.
Our support and consulting services for the European Medical Devices Regulation ensure you obtain the relevant information you need quickly so you can be certain that you are complying with all the requirements.
All four of the following criteria must be met for exemptions to justify the use of a persistent organic pollutant in a concentration exceeding the threshold:
- Potential exposure of patients or users to the substance must be analyzed and estimated.
- An analysis must be conducted for possible alternative substances, materials, or designs. They must be based on independent scientific studies, opinions from scientific committees and peer reviewed studies.
- Justified reasons must be given why possible substitutes for substances and/or materials or changes in the design – insofar as they are available or feasible – have not been applied regarding functionality, performance, and benefit-risk ratio of the device. Special account must also be taken for vulnerable patient groups, for instance, pregnant or breastfeeding women and children, who are regarded as especially vulnerable with regard to the substances and/or materials.
- The most up-to-date guidelines for the relevant EU scientific committee in accordance with Sections 10.4.3 (guidelines for phthalates) and 10.4.4 (guidelines for other CMR and endocrine-disrupting substances) are to be observed.
Special labeling requirements have been stipulated in accordance with 10.4.5, if devices, device components or materials in the devices contain substances used in a concentration exceeding 0.1% weight by weight that are listed in Section 10.4.1 or 10.4.1(a) or (b) of the Medical Devices Regulation. The controlled substances must then be listed on the devices themselves and/or on the individual packaging or under certain circumstances on the sales packaging. A list of substances must also be provided in addition to this information. If children, pregnant or breastfeeding women or other groups of patients who are particularly vulnerable to these substances and/or materials are affected, information must also be given in the instructions for use on the risks and precautionary measures.
Manufactures of medical devices must appoint at least one “qualified” person in their firm who is responsible for EU MDR compliance. The requirement to appoint an authorized representative for this applies to manufacturers based outside the European Economic Area. Our team of experts can provide guidance on all these procedures as part of our consulting and support services.
Manufactures of medical devices have to put risk management in place to comply with the MDR. They must also ensure that all their documentation and records are comprehensive, up-to-date, and complete. In addition, they must always be prepared for an on-the-spot audit. It is therefore advisable to establish meticulous practices for managing data and information. The MDR also stipulates that quality management systems must be documented.
Our team has many years of experience in the field of materials compliance and can provide you with all the help you need. Our support and consulting services are trusted by customers all around the world. Please don’t hesitate to get in touch with us to arrange a customized quotation or an initial, non-binding consultation.