Medical devices

Safety and performance are the cornerstones of the new EU regulation for medical devices and in vitro diagnostic devices. As a result, regulatory compliance has become more demanding than ever.

DHI can help you document the safety and performance of your devices and to overcome legal barriers globally.

Learn more about our expertise in

Brian S Nielsen

Tel.: +45 4516 9140
bsn@remove-this.dhigroup.remove-this.com

Poul Bo Larsen

Tel.: +45 4516 9478
pbl@dhigroup.com

Daniel Vest Christophersen

Tel.: +45 4516 9469
dvch@remove-this.dhigroup.remove-this.com

Our team

Our experts cover regulatory requirements, toxicology and biocompatibility and chemical compliance.

Together with our partners we can support you in all aspects related to technical documentation, design control and risk management, whether you are developing a new device, preparing for CE marking and registration or updating documentation for an existing device.

We offer flexible and pragmatic solutions depending on your needs for regulatory compliance:

  • short expert statements
  • fully documented reports
  • review and gap analyses of documentation 
  • planning and strategic regulatory advice 
  • in-house training and courses
  • templates and instructions for ISO 13485 compliance

Memberships

Medicoindustrien (Danish industry association)

  • Expert committee for biocompatibility
  • Network of consultants

Dansk Standard (Danish Standards)

  • S-258 Standardisation committee on updates to ISO 14155 (Clinical investigation of medical devices for human subjects) and ISO 10993 series on Biological evaluation of medical devices

Industrielt Farma og Medico Forum (IFF)

  • Drug-device network

Helping you towards MDR compliance

We offer expert advice on compliance with the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Our expertise covers all compliance and technical requirements related to regulatory toxicology, biocompatibility and chemical compliance. 

In addition, we collaborate with expert partners on quality assurance and quality control, design control, risk management, testing, verification and validation, and clinical affairs. In this way we can offer you a fully packaged solution to comply with the MDR.

How we have helped clients prepare for MDR:   

  • Review and update of technical file documentation for a medical device - to ensure product compliance changing classification from Class I to Class IIa under the MDR
  • Instructions and templates for a company quality management system – this ensured compliance with biological evaluation in accordance with ISO 10993-1, risk analysis in accordance with ISO 14791, and chemical compliance, bridging the requirements of REACH and MDR/IVDR
  • Training and company tailored courses and workshops - how to handle the requirements for physical and chemical characterisation of medical devices

 

CE marking and registration globally

We can support you with regulatory registrations in the EU and USA and in emerging markets such as Japan, China, South Korea, Brazil, Mexico and Russia. 

As experts in biocompatibility and toxicology, we can support you in preparing the biocompatibility report or summary for the submission file. We can also assist you in responding to questions from the authorities or clarifying local requirements. 

The US FDA has special requirements to biocompatibility documentation in addition to ISO 10993-1. We have hands-on experience with these requirements and have participated as experts in pre-submission and 510(k)-submission dialogues with the US FDA, including serving as toxicological experts in meetings with the US FDA. 

REACH legislation and medical devices

Placing medical devices, combination products and in vitro diagnostic devices on the market is complex. In addition to the regulatory requirements for medical devices, you must comply with chemical regulations and provide information relating to manufacturing, import, export and transportation of products, intermediates and raw materials. 

Certain chemical regulations also have requirements for labelling or consumer information on substances. This includes substances listed as Substances of Very High Concern (SVHC) under the EU REACH regulation or substances listed on California Proposition 65. According to the MDR, manufacturers must provide labelling if a device in contact with the body contains more than 0.1% w/w of a chemical with an EU harmonized classification as carcinogenic, mutagenic or toxic to reproduction (CMR) in category 1A or 1B or has been identified as an endocrine disruptor.

We can help you

Chemical compliance and regulatory monitoring should be an important part of your regulatory activities.

As experts in global chemicals regulations we can help you to obtain the right documentation and to comply with local regulations.

Examples of how we can assist you:

  • REACH registration of chemicals
  • Borderline issues: products covered by several regulations such as medical devices, biocides, drugs, chemicals or work environment
  • Templates and instructions on how to obtain supplier information on chemical composition, hazardous substances, and compliance with REACH, ROHS, the Waste Electrical and Electronic Equipment Directive (WEEE) or other relevant regulations 
  • IT solutions and databases for chemical compliance
  • Monitoring of global chemical regulations

Substitution of chemicals

With our in-depth toxicological expertise, we can help you find safe alternatives to problematic chemicals and to substitute hazardous chemicals. This includes preparation of applications for authorisation to use a chemical on the REACH Authorisation List (Annex XIV). We can also support you in replacing a chemical that is subject to regulatory restrictions because of CMR or endocrine disrupting properties.