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EU MDR Regulations

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  1. Medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers;
  2. Medical devices containing an ancillary medicinal substance to support the proper functioning of the device. Examples include drug-eluting stents, bone cement containing an antibiotic, catheters coated with heparin or an antibiotic agent, and condoms coated with spermicides;
  3. Medical devices made from substances that are absorbed by the human body to achieve their intended purpose;
  4. Borderline products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements.
  1. Improve the quality, safety and reliability of medical devices placed on the European market.
  2. Strengthen transparency of information related to medical devices for consumers and practitioners.
  3. Enhance vigilance and market surveillance of devices in use.
  1. New Structure and level of details of the contents for the technical file. (Annex II of the MDR)
  2. Establishment of compliance with” General safety and performance requirements.” (Annex I of the MDR)
  3. Requirement for a” person responsible for regulatory compliance” to be appointed within the manufacturer. (Article 15 of the MDR)
  4. New/revised procedures to be implemented to handle the new requirements including entering information into the databases. (e.g. Eudamed.)
  5. Strengthened requirements for post market surveillance, clinical evaluation, post market follow up and clinical investigations (Annex III XIV & XV). It should be noted that the processes for post market surveillance/post market clinical follow up should implemented as soon as possible, as the data generated will be very useful for documenting compliance to the new requirements when you apply for MDR or IVDR.
  6. Requirement for” summary of safety and clinical performance” for Class III devices and implantable devices. (Article 32)
  7. Generally, the conformity assessment system as we know it from the MDD is maintained. There are changes to the classification rules and some products are now assigned a higher class, requiring a more demanding conformity assessment process (for example, some products that used to be IIb are now class III and thus subject to a design examination.) In addition to this the assessment process at the notified body has increased in complexity and especially for class III & IIb implants and Infusion devices the scrutiny is increased.
  8. Implementation of Unique Device Identification system (UDI) processes and marking. The requirements for the UDI system are given in several articles (27, 28, 29 etc.) as well as annex VI.