Be confident of medical device market approval
The EU Commission has now published the second corrigendum to the In Vitro Diagnostic Regulation (IVDR) and Medical Devices Regulation (MDR) in the Official Journal of the EU (OJEU). It includes six corrections, some of which are minor editorial changes and three of which are related to registration requirements due to the delay of the European database on medical devices (EUDAMED).
During the first 18 months of EUDAMED’s availability, national reporting requirements will be replaced by registration certificates from EUDAMED Notified Bodies. Legal provision is also made for Notified Bodies to report certificates using national databases. If EUDAMED is delayed beyond the IVDR Date of Application (DoA) in May 2022, the due date of product and certificate registration will be extended.
The introductory phrase of Classification Rule 2 in Annex VIII contains a new insertion: “Devices intended to be used for blood grouping, or to determine foeto-maternal blood group incompatibility, or for tissue typing to ensure the immunological compatibility of blood,…” This means that devices for RhD testing for foeto-maternal blood group incompatibility will now be considered Class D, the highest risk category.
In December 2019, the Medical Device Coordination Group (MDCG) issued MDCG 2019-13. This offers guidance on the sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for technical documentation (TD) assessment. It expands on the sampling criteria and what must be included within a sampling plan. MDCG 2019-13 also clarifies tasks that must be performed by a Notified Body.
Article 52(4) and (6) of the MDR and Article 48(7) and (9) of the IVDR require the assessment of TD of at least one representative device per generic device group (for Class IIb and Class C) and for each category of devices (for Class IIa and Class B) before the Notified Body issues the certificate. The category of device corresponds to the relevant MDA/MDN codes (MDR) or IVR codes (IVDR) according to Regulation (EU) 2017/2185; a generic device group is defined as the fourth level of the European Nomenclature on Medical Devices (EMDN) (MDR) and as the third level of the EMDN (IVDR) in combination with the most appropriate IVP code.
A typical process for the sampling of TD for assessment should include:
The conformity assessment of Class D devices requires the involvement of an EU Reference Laboratory (EURL) to verify the performance claimed by the manufacturer and compliance with the relevant Common Specifications. Where no Common Specifications currently exist for a Class D device, an independent expert panel must provide its views on the manufacturer’s performance evaluation report within 60 days.
Implementing acts on the rules for tasks and criteria, as well as fee levels and structure, for European Union reference laboratories (EURL) were issued in November 2019. This requires EURLs to make their fee level and structure publicly available, and review them every six months. It also sets out the rules for cooperation between the reference laboratory and notified bodies, and covers issues such as response timelines, test types and batch testing. The competence areas of EURLs are also defined.
MDCG 2019-7 offers guidance on Article 15 of the MDR and IVDR regarding a PRRC. The PRRC must have a relevant university degree or a qualification that is recognised as equivalent by the Member State concerned. They must also have at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, as defined by the EU. Alternatively, the PRRC can have four years of professional experience in regulatory affairs or quality management systems relating to medical devices.
The PRRC must be an employee of the organisation and if a parent company has multiple manufacturers that are a legal entity, each one must have its own separate PRRC. Micro and small manufacturers, which do not have the appropriate internal resource, may outsource the PRRC role to an external organisation, with which the manufacturer has established a contract laying down provisions to ensure the permanent and continuous availability of that party. TÜV SÜD would also advise that a permanent and continuous linkage is established between the PRRC and the manufacturing activities. The PRRC should therefore be in the same region as the manufacturer.
Guidance document MDCG 2019-4 – “Timelines for registration of device data elements in EUDAMED” requires that EUDAMED registration of device data elements (listed in part A, Section 2, and Part B of Annex VI) are applicable from 18 months after the general application date. However, if EUDAMED is not fully functional on time, this would move to 24 months after the date of publication of the notice referred to in Article 34(3) of the MDR, which relates to the EU Commission verifying that EUDAMED has achieved full functionality and publishing a notice to that effect in the OJEU.
The MDR and IVDR mandate the use of unique device identification (UDI); the dates by which the UDI must be implemented will not be impacted by this delay.
This document refers to the application of transitional provisions concerning the validity of certificates issued in accordance with Directives 90/385/EEC (Active Implantable Medical Device Directive) and 93/42/EEC (Medical Device Directive).
Our supervisory authority advises that products under 93/42/EEC should continue to be evaluated on a sample basis. It is still unclear whether this should also be done for products certified under Directive 98/79/EC (IVDD). However, based on Footnote 1, this guidance can be also applied to Regulation (EU) 2017/746 on in vitro diagnostic medical devices. This means that the notified body that issued the original certificate for that product will continue to be responsible for the appropriate surveillance activities.
After the DoA, the Nando (New Approach Notified and Designated Organisations) Information System will list notified bodies that are allowed to carry out surveillance activities for valid certificates in the transitional period, but they will not able to issue new certificates.
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