The push to back implementation of the EU's new medical device and looming in vitro diagnostic regulations is coming at a steady pace this summer, with the European Commission releasing nine documents in July and August.
The stream of new documents, coming ahead of the anticipated release of a flurry of implementing acts in the third quarter, is meant to guide medtechs as they work to comply with the recently live MDR and the IVDR, which goes into effect next year.
Work in Europe typically slows down amid vacations over the summer months, particularly in August.
Not this year: The Commission released six documents in July ahead of the start of peak holiday season, making it one of the busiest months of the year, and has published a further three texts so far in August. A range of subjects are covered related to notified bodies, quality management systems, COVID-19 tests and other topics.
July began with the first opinion on clinical evidence under MDR. The Commission then released five documents in 10 days. One of the documents was an updated version of questions and answers about Eudamed registration but the rest of the texts were new.
One document explains the use of codes for the designation of notified bodies under IVDR. As the explanatory note from the Medical Device Coordination Group Document states, the codes are primarily designed to enable designating authorities to define the scope of a designation, but they can also be used by notified bodies to "describe the individual qualification" of staff and the "qualification required for assessing a device."
The Commission also released new MDR and IVDR forms for notified bodies. The forms can be used by conformity assessment bodies when applying for designation as a notified body under MDR and IVDR.
MDCG released the other two MDR and IVDR documents published in July. One of the texts provides guidance on how device and diagnostic manufacturers can integrate a unique device identification system into a quality management system. The integration is necessitated by MDR and IVDR. To help manufacturers meet the requirements, MDCG has published a list of considerations related to design and development, product documentation and retention, and other factors relevant to integration.
The other MDCG document released in July provides instructions for generating the CIV-ID unique single identification number for clinical investigations under MDR. CIV-IDs serve as tracking numbers for clinical investigation. Once Eudamed is fully functional, sponsors will be able to generate single identification numbers but for now MDCG is suggesting they obtain a CIV-ID from a competent authority before making their first submission. Alternatively, the CIV-ID may be given to the sponsor after it makes its first submission and then used for later applications to other member states.
After that burst of activity, the pace of publication slowed somewhat in August but MDCG has still put out three documents so far this month. One of the documents sets standards for developers of COVID-19 diagnostics, for example by listing how many samples companies need to test and what sensitivity and specificity they need to achieve. MDCG has set the minimum sensitivity for rapid antigen tests at 80%.
Another of the August batch of MDCG documents provides guidance for notified bodies, distributors and importers on the relabeling and repackaging of devices. Notified bodies need to certify that the quality management systems used by distributors and importers comply with the requirements set out in MDR and IVDR. The guidance is intended to help notified bodies understand the requirements.
The final MDCG document is a clarification of the term "first certification for that type of device." If a class D IVD lacks common specifications and is the first certification for that type of device, the notified body needs to consult the expert panel about the manufacturer's performance evaluation report. MDCG states the term means "there is no similar device on the market having the same intended purpose and based on similar technology."
More documents are in the pipeline. MDCG is working on a question and answer document to accompany its guidance on the relabeling and repackaging of devices, and the Commission's rolling plan features several implementing acts that are scheduled for publication in the third quarter.
This quarter, the Commission is set to release common specifications for products without a medical purpose and for IVD class D devices, an implementing act for Eudamed and a pair of texts related to EU reference laboratories. The two reference laboratory documents will cover rules to ensure their compliance with IVDR criteria and fees for the advice and testing activities they provide.
