This page is no longer maintained. On 26 May 2021 the EUMDR entered into application and the MDD was repealed.
The new EU Medical Device Regulation (EU MDR) is not radically different from the current Medical Device Directive (MDD). That’s not to underestimate the amount of work that will be required to switch from the current MDD to the new EU MDR. Certainly, for the manufacturer who produces medical devices for the EU market today, and who wants to continue supplying those devices beyond May 2021, complying with the new EU MDR will require a lot of additional work. However, very little of what is required by the new EU MDR is completely new. Most of the new requirements are really extensions to already existing requirements. In the majority of cases, these new requirements simply bring the EU regulations up to date and into line with the regulatory requirements for medical devices in the rest of the world.
Even though the current MDD is close to being 25 years old, the European standards and MEDDEV guidance has been continuously updated. As a result, a manufacturer who is fulfilling the current MEDDEV guidance on vigilance, clinical evaluation, clinical investigations and post market clinical follow-up, and the current EN standards for quality management and risk management, will find very little in the new EU MDR that they are not already addressing.
The following topics are retained in similar form to the current MDD;
- Classes of devices; the current four classes; I, IIa, IIb and III are retained without change.
- Classification rules; are essentially the same but with some new additions, most notably related to substances and software.
- Essential Requirements; renamed general requirements and extended, but can still be found in Annex I. Essential requirements checklists will definitely be longer in the future.
- technical documentation; the new requirements are clearer than before, and as with most other items, Technical Files will definitely be bigger in the future.
- Conformity assessment; the same concepts are retained with the manufacturer still being able to choose between different routes, although there is one less option compared to the MDD. However, the choice between different levels of assessment of the quality management system, the technical documentation or product testing remains essentially unchanged.
- Registration; – the requirements for registering the manufacturer are unchanged, however much more information about the device will be required in the future. Importers will also be required to register.
- Notified Bodies; the concept of Notified Bodies acting as delegates of the Health Authorities to perform pre-market assessments and routine surveillance audits is also retained, but Notified Bodies face a lot more requirements in the future and will be under a lot more supervision.
- The European database EUDAMED; the current database will be extended and in future some of the information will be publicly available.
- Vigilance; is retained with extended requirements which incorporate the content of the current Vigilance MEDDEV.
So, what is actually new in the EU MDR?
- Post Market Surveillance (PMS); Notified Bodies will play a bigger role in supervising the manufacturer’s PMS system. Additionally, the new EU MDR introduces a new requirement to produce a PMS Report or, depending on the device class, a Periodic Safety Update Report (PSUR). Although this is already established practice under EN ISO 14971.
- Unique Device Identification (UDI) – while UDI will be new for Europe, UDI has been an established requirement in the United States for some time already.
- Economic operators; it was clearly an omission that the MDD didn’t include requirements for importers and distributors. The new EU MDR corrects this omission but really only brings European importers and distributors into line with already established practices for importers and distributors of medical devices in other geographies.
That leaves only a couple of requirements in the new EU MDR which are truly novel:
- the requirement that at least one person in the organization be formally assigned responsibility for ensuring the regulatory compliance of the enterprise (again not really new for those organizations which already have a Quality or Regulatory Compliance or Safety Manager).
- the extension of the scope of the medical device regulations to products without an intended medical purpose but which are analogous to devices with a medical purpose. This is aimed at medical device like products typically intended for cosmetic purposes. Colored non-corrective contact lenses being the most frequently quoted example.
An excellent article and one that really calms down the stress levels after reading all those other articles about how much work will be required and how much has changed, etc. etc.. For those of use who have been keeping up with the regulations, this is very doable and there is no need to panic. Thanks so much.
Thank you for your feedback.
which guideline reffer for clinical data or clinical testing of 11a and III classified products.
Thank you for your question about clinical data requirements.
Clinical data requirements are not determined by the class of the device but by the clinical evaluation (Annex XIV). The Medical Device Coordination Group is expected to release guidance on what it considers sufficient clinical evidence, but this will not alter the requirement to perform a clinical evaluation in the way that is described in Annex XIV. For more detailed guidance on performing a clinical evaluation consult MEDDEV 2.7/1 revision 4 of June 2016. Although the MEDDEV was written to support the Directives, the guidance is fully transferable to performing a clinical evaluation according to the EU MDR.
In Canada it is also called the MDR and is what is submitted as part of obtaining an MDL(license). The MDR is a living document and needs to be kept current until device End of Life (EOL) date
As I understand it, it will also be increased requirements for clinical evidence, including an expectation for higher risk devices that clinical investigations specific to the device in question will be performed. This is not included in the listing above. Is there a reason for this?
Thank you for your question about clinical evidence and investigation requirements.
With regard to clinical investigations of higher risk devices: EUMDR Article 61 (4) “In the case of implantable devices and class III devices, clinical investigations shall be performed, except if: …the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.” is virtually identical to MDD Annex X 1.1a “In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.”. Manufacturers of implantable devices and class III devices will most likely not perceive much difference compared to the current Directive’s requirements.
With regard to clinical evidence in general: All devices already require more clinical evidence than was initially the case under the Directive. That deficiency was addressed by the 2016 revision of MEDDEV 2.7/1. The medium risk (Class IIa) devices were affected the most by that change because many had previously relied on claiming equivalence to other devices rather than their own clinical evidence. While the EUMDR maintains the enhanced clinical evidence requirements introduced by MEDDEV 2.7/1 2016 it doesn’t really add to them.
See page https://eumdr.com/clinical-evaluation-compared/