DON’T LET THE IVDR
TAKE YOU BY SURPRISE
The deadline to fully comply with the In Vitro Diagnostic Regulation (IVDR) is just around the corner.
Are you ready?
May 26, 2017
EU IVDR published and entered into force
NOV 26, 2017
Notified bodies may apply for designation according to the EU MDR
May 26, 2022
EUDAMED goes live
MAY 26, 2022
IVDR Date of Application. EC Certificates of Conformity issued before May 26, 2017 will expire. Certificates issued under the IVDD after May 26, 2017 are valid for an additional 2 years
MAY 26, 2024
All devices placed on the market must conform with IVDR. EC Certificates issued after May 26, 2017 become void
MAY 26, 2025
All devices with IVDD certificates can no longer be sold or put into service
Orielstat is keeping an updated list that you can check here. As of 12/15/2019, 9 designated MDR-notified bodies have been approved, along with 3 IVDR bodies. Another 10 have confirmed they are seeking MDR approval status and 2 have confirmed they are opting out. The best way to find out the status of your current notified body partner is to contact them directly.
Not all notified bodies have published their language requirements. The list of languages provided here may not be exhaustive, and we recommend you contact your notified body to confirm whether they accept submissions in the language your company does business.
English will still be an official language of the EU for Malta and Ireland when the UK withdraws. Since the notified bodies are required to be located within the EU, there will certainly be an impact on any notified bodies located in the UK (currently BSI is approved with a UK presence). When the UK is no longer considered a member state, BSI UK will no longer be able to act on behalf of the EUMDR to certify products. Many or most of the certified bodies accept English as a submission language, so it should not affect US companies for the translation of submission documents at this time.
Brexit is expected to also create additional bottlenecks around notified body approvals since there are a very low number of bodies approved. Bottlenecks are already expected by industry experts, since there are not enough notified bodies certified to manage the upcoming MDR submissions. The biggest impact of Brexit is likely to come in the form of additional submissions to the MHRA in the UK. The MHRA has set the same deadlines as the MDR for compliance periods (May 2020 and 2022). The UK is no longer a part of the EU as of January 31, 2020. However, during the transitional period for Brexit (which extends until December 31, 2020) more information should become clear on how Brexit will affect medical device regulations. To be fully prepared, medical device companies should plan for a parallel submission path and evaluate the role of their authorized representatives and/or manufacturers in the UK to determine future compliance.
The notified body shortage is likely to impact medical device companies in different ways. However, it will certainly have an effect on the market as well. Many of the experts on MDR and IVDR believe this will be the main hurdle to compliance. This RAPs article posits that only 27% will be compliant with the new regulations by this May. Some devices may be discontinued or pulled from the market strategically, and some devices will be unavailable due to unintended gaps between certificate expiration and recertification under MDR. Some experts have noted that this has led to a higher volume of initial submissions going through other regulatory bodies (i.e. the FDA) for first approval rather than first submission in Europe. Many companies are finding that it will no longer be easy to get CE-marked first for new products, since bottlenecks are expected with the new notified bodies. This is actually creating additional volume and delays with US FDA approvals.
The EFTA (European Free Trade Association) consists of Iceland, Liechtenstein, Norway, and Switzerland. The CE marking currently allows for medical devices to pass through all EFTA and EU countries freely, so these countries and Turkey will need to bring their requirements and regulations in line with the MDR to continue trading medical devices under the CE mark. The Swiss government has already agreed to align with the MDR and IVDR requirements and have timed MedDo changes to coincide with MR changes while signing an agreement to allow for the mutual recognition of devices. Norway has already started taking responsibility for their own devices, and the Turkish TMMDA agreed to adopt all crucial requirements for MDR as well. Medical device manufacturers will need to evaluate the compliance of manufacturers and authorized representatives in these territories.