Class I medical devices between Directive and Regulation
Regulation (EU) 2023/607 has amended Regulation (UE) 2017/745 (MDR) extending the transitory period and defining the criteria to benefit from such extension.
While for medical devices (MDs) belonging to higher risk classes according to Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) the parameters to enjoy the extension are quite clear, for class I devices the framework is less intuitive.
In fact, except for custom-made devices, while on one hand manufacturers of devices formerly of class IIa, IIb and III according to the past directives the main criterion to consider to understand if the conditions for the extension are applicable to one’s product is the state of validity of the certificate on 20 March 2023, and the classification according to the rules of the MDR only affects the date of the certificate time extension, on the other class I device manufacturers have to consider several aspects.
In particular, it should be considered if the MD was under self-certification according to the MDD, the date of release of the declaration of conformity according to directive previously in force should be taken into account, and it should be evaluated from the beginning which class the MD belongs to, based on the rules of annex VIII of MDR.
The latter is an essential point since any reclassification according to the MDR of class I devices according to the MDD into a higher class can determine the previously unrequired involvement of a notified body (NB) in the conformity assessment process.
In light of the above it is possible to summarize three possible cases.
CASE 1
If the MD was in class I according to the directive and no NB involvement was required in the conformity assessment, and if, applying the rules of classification of annex VIII of the MDR, the OB involvement is not requested anyway, the extension is not applicable to the concerned device: the MD is a class I under self-certification according to the MDR and, as such, it should have been fully compliant with the regulation within its date of application (i.e., 26 May 2021).
CASE 2
If the MD was in class I according to directive and no NB involvement was required in the conformity assessment but, applying the rules of classification of annex VIII of the MDR, the NB intervention results as necessary according the new regulation, the MD can enjoy the extension, provided that the declaration of conformity according to the MDD was drafted before 26 May 2021. In this case, the same conditions to obtain the extension apply as those applicable to other legacy devices, i.e.:
• no significant changes were introduced in the design and intended use;
• it is still compliant with the MDD;
• it presents no unacceptable risks;
• a SGQ MDR is instituted and an official application is submitted to a NB for the conformity assessment no later than 26 May 2024, and a written agreement with the NB is signed later on within 26 September 2024.
If all the above said conditions are in place, the manufacturer can continue to put on market class I MDs according to the MDD under self-certification until 31 December 2028.
CASE 3
If the MD was in class I according to the directive and a NB involvement was required in the conformity assessment (e.g. if sterile or with a measuring function) and was covered by a certificate that was valid on 20 March 2023, the same conditions to obtain the extension apply as described in CASE 2.
When these conditions are met, also in this case the manufacturer can continue to put the MD on the market until 31 December 2028, by virtue of the extension of the certificate released as per the MDD until that date.
In case the MD certificate expired before 20 March 2023, the MD can enjoy the extension (always provided that the conditions described above are met), only if an agreement was signed with a NB before the certificate expiry or if, before 20 March 2023, the waivers described in article 59.1 or article 97.1 of the MDR were applied.
Di Renzo Regulatory Affairs can support class I device manufacturers in the transition to the new legal framework, helping them to evaluate the appropriate classification of their MDs according to the MDR, in order to define a suitable timeline for the extension and schedule the transition to the regulation in the best possible way. We can also support you in the drafting of technical documents and assist you in the conformity assessment process.
Written on 7/05/2024 by: Simone Pippa
