Compromise in MDR/IVDR Trilogues:

Regulators shared that they expect that the First Reading versions will be agreed upon in mid-June 2016.

As a brief reminder, the MDR (Medical Device Regulation replacing what is now called the Medical Device Directive (MDD) and IVDR (what is presently called the In Vitro Diagnostics or “IVD”) are still in what is called “The First Reading Stage” and that the European Parliament, Council, and Commission are now negotiating a compromise text that can be presented as a final First Reading document.

Based on the Council version from September 2015 and the ensuing discussion, Methodize anticipates that the new Regulations will require a higher level of clinical evidence to be reviewed by a smaller group of intensely reviewed Notified Bodies (note that this expected decrease in Notified Bodies was articulated in an earlier Methodize article). Also, many more IVDs will likely require Notified Body review and certification. Additionally, the public will have access to more data about the devices and their safety via the updated/ improved Eudamed database.

In anticipation of this important milestone in the MDR/IVDR review process, Methodize would recommend that all manufacturers review the draft documents to verify device status (with special attention to accessories and products are not within scope of the Directives, but may fall within the scope of the Regulations), verify the risk class, and perform an initial gap assessment for conformity assessment; Methodize can assist companies through this process. Although this “First Reading” version is not yet available, it is expected that the definitions and most of the classification rules will not differ much from the Council’s versions of the proposals ( MDR and Annexes) and IVDR (and all the Annexes)).Once the First Reading document is available, product status and classification can be verified again.

Also of interest, Methodize has learned of a few developments in the draft MDR and IVDR documents from the First Reading negotiations at a recent Team NB meeting in Brussels. Firstly, the Special Notified Body designation has been removed. Additionally, it has been discussed that the scrutiny procedure will be performed by a panel of experts (rather than the Medical Device Coordination Group), and the focus is going to be primarily on implants and Class D (note that the old IVDD directives classified products by “List A”, “List B” and then “List Other”. The new IVDRs will now have 4 classes (A-D with class D being the highest) IVDs (though some Class IIb devices may be subject to the scrutiny procedure, as well).

Decrease in Notified Bodies
There has been a 25% reduction in the number of Notified Bodies following the European Commission’s joint assessments. This is of course expected to decrease further (likely at one point there were some 80+ NBs, now being reduced to ~15 or less).

Case Study: Commission Decision
The European Commission recently posted an example of Articles 13 and 7 of the MDD 93/42/EEC in action. Under Article 13(1)(d), Member States may approach the Commission with a request to clarify whether a particular product or product group are medical devices based on the definition provided in Article 1.

The decision states that France approached the Commission about the classification of products using proanthocyanidins (PAC) present in cranberry extract to prevent or treat cystitis. The Commission agrees that these products are not medical devices, because the primary action is achieved by pharmacological, immunological, or metabolic means (“inhibiting adhesion between P-fimbriated E. Coli and mucous membrane cells in the urinary tract”). This Decision is permissible according to Article 7.

ISO 13458:2016

Methodize would like to remind all interested manufacturers of Methodize’s recent information about the new ISO 13485:2016 standard (NOTE: there will be no accompanied document available to help someone interpret the new ISO 13485:2016 e.g., ISO 14969 which was originally drafted to help industry interpret ISO 13485:2003), this information contains an overview of changes in the new standard and guidelines on how to prepare for the new standard; this will be upcoming.
[MDD and IVDD]

Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell)