Conformity assessment in the new European Union Medical Device Regulation (EU MDR) is essentially unchanged from the current Medical Device Directive (MDD). The MDD’s conformity assessment Article has really just been renumbered, Article 11 of the current MDD will be replaced by Article 52 of the new EU MDR. Likewise, the Conformity assessment Annexes have been renumbered and renamed; Annexes II to VIII of the current MDD, will be replaced by Annexes IX to XI and XIII of the new EU MDR. But apart from that, the requirement for Manufacturers to conduct a conformity assessment before placing their device on the market, and for higher risk devices to involve a Notified Body, is unchanged.
Class III devices: The current MDD’s Annex II “full quality assurance” route will be replaced the new EU MDR’s Annex IX “conformity assessment based on quality management system assurance and assessment of the technical documentation”.
There are still alternatives for those Manufacturers who chose not to follow the full quality management system approach. The current MDD alternative for Class III devices of Annex III “EC type-examination”, combined with either Annex IV “EC verification” or Annex V “production quality assurance”. Will be replaced by the new EU MDR’s Annex X “conformity assessment based on type examination” combined with new Annex XI “conformity assessment based on product conformity verification”. While it might appear that the Manufacturer has less alternatives in future compared to the MDD, this is not the case. The alternatives in the new EU MDR are essentially identical to those of the current MDD. The new EU MDR’s Annex XI “conformity assessment based on product conformity verification” includes both the MDD’s current options; Part A being the new “Production Quality Assurance” route, replacing the current MDD’s Annex V “production quality assurance”. Part B being the new “Product Verification” route, replacing the current MDD’s Annex IV “EC verification”.
While the above comparison shows the conformity assessment procedures for class III devices in the new EU MDR are essentially the same as those in the current MDD. That doesn’t mean the transition to the new EU MDR will be easy. In addition to additional safety and performance requirements in Annex I, and the additional requirements for Technical Documentation, Quality Assurance, Clinical Evaluation and Post Market Surveillance, the new Article 52 also places additional requirements on the Notified Bodies to consult with Health Authorities and EU expert panels. Meaning, not only will the conformity assessment procedures generally be more demanding, in the case of Class III devices they are also likely to take considerably longer. See the dedicated page on the Consultation procedures.
Class IIb devices: As under the current MDD, Manufacturers of Class IIb devices have the option of following the same conformity assessment route as for Class III devices described two paragraphs above. Namely, the new EU MDR’s Annex IX. The difference being that the Notified Body is only required to assess the technical documentation of at least one representative device of each generic device group produced by the Manufacturer. Again, as with the current MDD, there are alternative routes for Manufacturers of Class IIb devices who chose not to follow the full quality management system approach. These alternatives are again the same as those for Class III devices described in two paragraphs above. However, there is one fewer alternative available to Manufacturers of Class IIb devices compared to the MDD. There is no equivalent to the MDD’s Annex VI “product quality assurance”. Manufacturers currently following this route will have to choose an option from the new Annex XI. Either Part A, “Production Quality Assurance”, or Part B, “Product Verification”.
Class IIa devices: As under the current MDD, Manufacturers of Class IIa devices have the option of following the same conformity assessment route as for Class IIb devices described above. Namely, the new EU MDR’s Annex IX, with the Notified Body only assessing representative technical documentation. Again, Manufacturers may choose not to follow the full quality management system approach. In which case the approach is essentially the same as the current MDD’s Annex VII “EC declaration of Conformity” combined with either Annex IV or Annex V. I.e. Having compiled the new Technical Documentation (new Annex II) the Manufacturer prepares the new “EU Declaration of conformity” (new Article 19), and then the Notified Body either; (a) assesses the Technical Documentation of a representative sample of the devices (Annex XI, Part A, Section 10), or (b) carries out tests to confirm the conformity of the devices (Annex XI, Part B, Section 18).
Class I devices: The approach is essentially the same as in the current MDD Annex VII “EC declaration of Conformity”. Namely, the Manufacturer prepares the new EU Declaration of conformity (new Article 19), having of course first fulfilled the general obligations of all Manufacturers (new Article 10). As is the case under the current MDD, the involvement of a Notified Body is limited for Class I devices, and is only required for sterile devices, reusable surgical instruments or devices with a measuring function.
Custom made devices: Unlike the current MDD where the requirements for customer made devices are part of the current MDD Annex VIII. The new EU MDR has a dedicated Annex, Annex XIII “procedure for custom made devices”. However, the requirements to draw up a statement about the device and keep records etc. are fundamentally the same as in the current MDD. The exception being Class III custom made devices, where a quality system assessment by a Notified Body is required; either the “quality management system assessment” of the new Annex IX, Chapter 1 or the “Production Quality Assurance” of the new Annex XI, Part A.