May 2020 MDR Deadline Problems
Despite recent flat denials of problems with Notified Body designation and the medical device industry crying for help or some relief versus the May 2020 deadline for MDR, the European Commission has admitted the potential for supply difficulties in a document published on 17-Jun-19 entitled ‘Factsheet for healthcare professionals and health institutions’ This raises many questions for the industry not least manufacturers and their capability to continue to produce medical device products. This fact sheet advises the healthcare sector to prepare for possible shortages of some medical devices and IVDs in the event that manufacturers do not meet compliance deadlines for the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).
Reasons given include:
- Risk reclassification of some devices under the MDR will require additional steps for manufacturers in order to comply;
- New risk classifications for IVDs will necessitate Notified Body (NB) oversight for about 85% of such products under the IVDR versus about 20% under the current In Vitro Diagnostic Medical Device Directive (IVDD);
- Medical devices, IVDs and services available for sale online will require MDR or IVDR compliance in order to remain available in Europe.
This presents a significant problem for the supply chain where:
- All medical devices and IVDs need to be re-registered under the new Regulations. And a 9-month timeline is being quoted by NBs for re-registrations.
- To date only 2 NBs (BSI and TUV SUD) have been designated under the new Regulations and other NBs, who are in the process of obtaining approval, are specifically forbidden from taking applications under the MDR and IVDR regulations prior to designation being formally completed.
- The EC still expects to designate 20 NBs under MDR by year’s end but much fewer than before when there were 60+ designated NBs.
- In recent weeks 2 highly-regarded NBs with significant CE Mark business have withdrawn, namely, LRQA (UK) and QS Zürich AG (CH).
- The Spanish NB, Spanish Agency of Medicines and Medical Products (AEMPS), has issued a statement saying that they will not accept new applications after July 31st from either new or existing clients.