Although in previous posts I showed my apprehensions about a possible extension period for class I medical devices, the last December the EU Parliament approved a new corrigendum to the Medical Devices Regulation (MDR) that provided a four-year ‘grace period’ for manufacturers of class I medical devices which will be up-classified by MDR.
This means that, in the same way, as those as class IIa, IIb or III medical devices with a CE certificate issued under the Medical Device Directive (MDD) can be on the market until May 2024 the latest, those class I medical device with an issued Declaration of Conformity (DoC) according to the MDD marketed before 26th May 2020 (date when new MDR will finally take effect) could also benefit from this grace period, not being therefore necessary the assessment by a notified body for the first time under the MDR.
Essentially, this provides class I manufacturers which will be up-classified much more time to prepare its technical documentation, quality management system, etc., to obtain a CE certification after a notified body assessment in accordance with the MDR requirements.
Does this mean that class I manufacturers can sit back and do nothing? Not really, since according to the transitory provisions of Article 120, paragraph 3 of the MDR “The requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives“. Therefore, since May 26, 2020, all of the aforementioned needs must be met for the MDR, having a current certificate and/or DoC according to the MDD or not.
In addition, and this an important subject to bear in mind, no significant changes can be made to the intended purpose and design of relevant device post-26 May 2020. The problem here is that the concept of “significant change” is pretty unclear. For class IIa, IIb or III manufacturers their notified body will decide what is a product significant change or not, but for class I should be the own manufacturer or its sanitary authority who decides if the change can be implemented without any warning or if it needs a recertification and therefore, going under an MDR assessment.
With no notify body watching over the fulfillment of MDR requirements and/or implementation of significant changes for class I medical devices, could lead manufacturers to assume a risky situation of placing the medical device according to the MDD and do not implement new MDR requirements and/or do not communicatee significant changes (or at least ask the competent authority if it is a significant change or not). But the problem is that, as soon as retrospectively appears that that company has made a significant change or did not follow the MDR requirements to be applied, it means that you have had a product with a CE mark illegally…with the consequences it means.
Therefore, independently if your products are going to benefit for this extension period or not, our advice is to start right now with the adaptation of the technical dossiers of the products to the requirements of the MDR, carrying out the preclinical tests and necessary clinical investigations, as well as, implementing a strong quality management system according to ISO 13458.
If you need support, do not hesitate to contact ZURKO Research, we can help you.
by Juan Ángel Gracia García
Medical Device Technical Director