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Specialist information on MDR

Medical Devices Regulation

Manufacturers must comply with a wide range of regulations if they want to sell medical devices on the European market or globally. Some substances and materials are banned in some countries or economic areas such as the EU. There are also many regulations and laws for packaging and transportation. Some requirements apply through the Medical Device Regulation MDR, the EU Medical Device Regulation 2017/745. Medical devices can also be affected by the RoHS Directive, the REACH chemicals regulation, the POPs regulation, California Proposition 65 or specifications on conflict minerals or the SCIP database. In addition, the EU Supply Chain Act and the Dodd-Frank Act impact the industry. We help you navigate this legal jungle and design a safe and efficient material compliance process.

In May 2021 – one year later than planned due to the Corona pandemic – the European Medical Devices Regulation 2017/745/EU, abbreviated MDR, came into force. Since then, manufacturers of medical devices and other players in the supply chain have had to fulfill a wide range of material compliance requirements. Previously, the Medical Device Directive (MDD) 93/42/EC and the Active Implantable Medical Devices Directive (90/385/EEC) applied. In a sense, the MDR succeeds these legal requirements and has also brought higher material compliance requirements for medical devices in the EU. In addition, the new MDR no longer applies only to products with a medical purpose, but also, for example, to cosmetic and other products such as contact lenses, aesthetic products, and implants.  

The European Database for Medical Devices EUDAMED, which has been mandatory for all EU member states since 2011, will also be expanded as part of the introduction of the MDR. Thus, product-relevant data on every product sold in the EU must be made available in EUDAMED, as well as data on manufacturers, importers or distributors. A uniquely assigned product number, the “Unique Device Identification”, was also introduced. This is intended to create transparency in the supply chain and facilitate recalls. In addition, a new symbol has been introduced for medical device labels: the “MD” marking.

Since May 2021, products that are not compliant with the substance requirements may no longer be placed on the market. Substances regulated in the MDR must be identified and their presence justified. Otherwise, the technical documentation and consequently the conformity assessment procedure are invalid. Transitional provisions under Article 120, paragraph 2 of the MDR apply until May 27, 2022, or May 27, 2024, until which time certificates of compliance under the previously applicable MDD are still valid and products may be placed on the market, even if they are already subject to MDR regulations. Restrictions also apply to sales: The approval of products placed on the market under the old MDD regulation applicable to medical devices until May 25, 2020, expires on May 27, 2025 – until then, for example, stock products may still be sold and used.

The so-called Notified Bodies, which are responsible for the certification and conformity assessment of medical devices according to MDR, can, according to the new regulation, carry out unannounced audits at the manufacturers, who are obliged to provide extensive technical documentation. To comply with the new medical device legislation and limit liability risks, manufacturers and suppliers should therefore use workable communication and data exchange systems and also adapt current contracts. This is a comprehensive process that many companies have already underestimated. This is where we can help you with our service – even at short notice – just contact us. 

All components of medical devices must be compliant with the new requirements. This means that so-called CMR substances (derived from Carcinogenic, Mutagenic and toxic to Reproduction) may not exceed a proportion of 0.1 percent. The individual materials in the product components are taken as the reference value. For certain areas of application, there are exceptions for higher concentrations of these chemicals (see chapter 10.4.2 of the MDR). CMR substances are substances that have been shown to cause cancer, alter genetic material or endanger reproduction.

Specifically, the MDR regulates the handling of substances described in Annex I, 10.4. as:

“(a) substances that are carcinogenic, mutagenic or toxic to reproduction (“CMR substances”) of category 1A or 1B as defined in Part 3 of Annex VI to Regulation (EC) No. 1272/2008 of the European Parliament and of the Council (1); or

(b) substances with endocrine disrupting properties that have been scientifically identified as likely to have serious effects on human health, either in accordance with the procedure laid down in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once the Commission has adopted a delegated act in accordance with the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (3), in accordance with the criteria relating to human health set out therein.”

If the following criteria apply to them, products or product components and materials used therein must not exceed a concentration of 0.1% by mass of the substances described in the previous section:
  • They are used invasively and come into direct contact with the human body.
  • They administer or extract (repeatedly) medicines, body fluids or other substances, including gases, from the body.
  • They transport or store drugs, body fluids or other substances, including gases, which are administered to the body (repeatedly).
According to the MDR, manufacturers of such medical devices already have to ensure that their articles meet certain requirements, such as those described in Annex I – including material requirements – on safety and performance. Failure to do so could result in a ban from circulation. Only if all provisions are correctly fulfilled, manufacturers will receive a valid CE marking for their articles after an EU declaration of conformity. If you are unsure whether the MDR applies to your products or materials, contact us!

Not all medical device manufacturers have yet adapted to the strict material compliance requirements imposed by the European Medical Device Regulation MDR. This is because these partly require new mechanisms and systems for customer and supplier communication.

Material requirements for articles can be found in the safety and performance requirements in Annex I of the Medical Device Regulation MDR (see Chapter 2, 10.4. Substances). According to the MDR, this evidence is mandatory for the Technical Documentation (see Annex II, 4. Essential Safety and Performance Requirements).

Depending on the risk class to which a product or article has been assigned, a different conformity assessment procedure is provided. For example, a new risk class “lr” has been created for reusable surgical instruments. For products in risk classes IIa and IIb as well as III and for some products from class I, a “Notified Body” must be involved. For some high-risk products from classes IIb and III, a new consultation procedure (“scrutiny procedure”) is also envisaged, in which an independent panel of experts is also involved.

With our service and consulting on the European Medical Devices Regulation, you will quickly find the information you need on the topics that are relevant to you and will be sure to meet all the requirements.

For exemptions to justify use of the persistent organic pollutants above the stated limit, all of the following four criteria must be met:
  • The potential exposure of patient:s or user:s to the substance must be analyzed and estimated.  
  • An analysis of possible alternative available substances, materials or designs is required. This must be based on independent scientific studies and opinions of scientific committees, as well as peer-reviewed studies.  
  • Justification must be provided as to why possible substitutes of substances and/or materials or changes in design, if available or feasible, are not appropriate in terms of functionality, performance and risk-benefit ratio of the product. Sensitive groups of patients must also be taken into account, for example pregnant women, nursing mothers or children, who are considered to be particularly vulnerable with regard to these substances and/or materials.  
  • The most recent guidance from the relevant EU Scientific Committee as set out in sections 10.4.3 (guidance for phthalates) and 10.4.4 (guidance for other CMR substances and substances with endocrine disrupting properties) shall be taken into account.
In the case that the products, product components or materials used contain substances in a concentration of more than 0.1 percent by mass that are found in section 10.4.1 or 10.4.1 a or b of the Medical Devices Regulation, there are special labeling requirements according to 10.4.5. The regulated substances must then be named on the products themselves and/or on the individual packaging or, under certain circumstances, on the sales packaging. In addition to this information, there must be a list of substances. If children, pregnant women, nursing mothers or other groups of patients who are particularly susceptible to these substances and/or materials are affected, information on risks and precautions must also be included in the instructions for use. 

Manufacturers of medical devices must designate at least one “qualified person” in their company who is responsible for compliance with the EU MDR Regulation. For manufacturers located outside the European Economic Area, there is an obligation to designate an authorized person for this purpose. With our consulting services and our service, our Expert:innen team is available to assist with all further steps.

According to the MDR regulation, manufacturers of medical devices must establish a risk management system. In addition, numerous verifications and documentations must be kept – always against the background that a manufacturing company must be prepared for unannounced audits. Therefore, it is advisable to establish a careful management of data and information. A system for quality management must also be demonstrated in accordance with the MDR regulation.

In all these tasks, the imds professioinal team, which has been a global leader in the field of material compliance for many years, will support you with service and consulting. Simply contact us for an individual offer or a non-binding initial consultation.