Ireland’s Health Products Regulatory Authority (HPRA) has released issue 53 of its Medical Devices newsletter which is focussed on preparing manufacturers for the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
MDR transitional provisions
The Medical Devices Directive (MDD) and the Active Implantable Medical Device (AIMD) directive will be repealed and replaced by the MDR from 26 May 2021. To support the continued supply of medical devices to the European market, Article 120 of the MDR sets out a number of transitional provisions for device manufacturers. For instance, the deadline for inclusion of unique device identifiers (UDIs) on device labels may be extended depending on the device classification. For devices with no significant change to their design or intended purpose, the aim is to ensure minimal disruption during the transition period.
Certain requirements of the MDR will apply to legacy devices, namely those relating to post-market surveillance, market surveillance, vigilance and registration of economic operators and devices in the European database on Medical Devices (EUDAMED). It is important to note that as the implementation of EUDAMED is currently delayed until September 2021, the Medical Device Coordination Group (MDCG) has released guidance on alternative technical solutions that can be used until EUDAMED becomes fully functional.
EU cooperation and guidance
Further updates from the MDCG regarding their latest documents are detailed in the newsletter to highlight the work from the EU to oversee the continued implementation of both the MDR and the IVDR. There is a particular focus on IVDR implementation from the European Commission and this is overseen by the IVD Working Group.
Custom-made devices are another key area of focus in the incoming regulations and as such the regulatory considerations for these devices are highlighted in the newsletter. A Q&A from the MDCG covers this topic in detail.
Annex I of the MDR specifies the general safety and performance requirements of medical devices which includes those relating to the inclusion of carcinogens, mutagens and reproductive toxins (CMRs) in medical devices. Generally, devices must be designed to reduce the potential risk of these substances being released by taking into account wear debris, degradation products and processing residuals. However, devices that contain CMRs in concentrations above 0.1% w/w may be allowed if their presence is adequately justified.
The final section of the newsletter details HPRA-specific information regarding the incoming device regulations. A non-exhaustive introductory reference list for Class A medical device manufacturers has been developed by the HPRA to help IVD manufacturers coordinate their regulatory activities and ensure compliance ahead of the May 2022 IVDR implementation date.
The HPRA also details that whilst they are in a position to accept applications to conduct clinical investigations of non-CE marked medical devices under the MDR, they are unable to issue authorisations until after the date of application.
A brief discussion on the impact of Brexit on the MDR is included, with the HPRA highlighting its key guidance documents on the matter. A table is provided that details the important regulatory changes for economic operators, outlining the key changes for manufactures and for distributors/importers of medical devices.
With the date of application of the MDR round the corner, it is imperative you assess your MDR preparedness which can be done with our SMARTCHECK MDR tool.
In addition, our very own Kim Wharton and Malcolm Pinfold sat down to discuss the MDR and summarise the key implications for manufacturers to note. Watch here for a summary of the incoming regulations.