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 2020, 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.