European industry provides opinions on two important topics: MDSAP and Clinical Strategy

MedTech Europe, together with COCIR and other European industry associations, have published joint papers on two important topics for medical device manufacturers in the context of the forthcoming review of the Medical Device Regulation (MDR, 2017/745).

The topics are:

• Recognition of MDSAP certificates for the purpose of CE marking, and
• Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body

The first paper, copy available from here, addresses the perceived multiple benefits of the EU becoming a full member of the Medical Device Single Audit Program (MDSAP), “thus aligning the EU with a global initiative that prioritises high standards, patient safety, and innovation in the medical technology industry.”

The paper concludes that: “It is time for the EU to take this strategic step, ensuring that European patients, industry, and regulators all benefit from a more streamlined, efficient, and globally recognised regulatory framework.”

The second paper addresses industry’s “concern that the recently updated MDCG 2019-6: ‘Requirements relating to notified bodies revision 5’, while providing further framework for pre-submission structured dialogue, has not addressed the ongoing absence of clinical strategy discussion”. As a result, the paper predicts that “the gap in clinical evidence expectations will persist – with serious consequences for our industry and for devices continuity.”

The paper, copy available from here, explains that the situation needs to be addressed by the European Commission and the EU Member States as a matter of priority to allow legacy devices to transition on time as well as to support the introduction of innovative technologies, citing the following:

• Clinical strategy is developed by the manufacturer far in advance (months or even years) before the application for conformity assessment; hence the need to discuss it before submission.
• Early alignment on clinical expectations between the manufacturer and the Notified Body (NB) will lead to clinical investigations/evaluations that meet NB expectations, with a reduction of conformity assessment timelines.
• The lack of possibility to discuss clinical strategy pre-submission will to have a particularly negative effect on small & medium sized enterprises (SMEs). Due to their limited resources (financial and personnel), without an improved clinical strategy discussion it would be extremely damaging for SMEs to have to re-work sunmissions with new clinical data, and it might be impossible to re-invest in the newly expected data gathering.

The paper concludes: “MedTech Europe, AESGP, MedTech & Pharma Platform and COCIR strongly urge the European Commission and the EU Member States to clarify in the foreseen implementing act for application of uniform rules for Notified Body requirements that high level discussion of clinical strategy can take place ‘before submission of the application’. This will allow alignment on expectations between manufacturers and Notified Bodies; thereby reducing the likelihood of rejections and improving predictability of the conformity process.”