Although the date when the Medical Devices Regulation (MDR) 745/2017 takes effect has been delayed, introduction of increasingly strict checks on the quality of our products has not.

On 17 April, the European Parliament formally voted on the proposed deferment of the application date of the MDR 745/2017.

The Regulation, which repeals Directive 93/42/EEC, sets forth the detailed obligations and responsibilities for all economic operators on the medical device distribution chain, in terms of checks on safety and conformity.

The European Parliament presented, and supported, the four technical amendments proposed last week by the European Council, without making any further changes. This means that all three EU institutions supported both the one-year delay in the date of application of the MDR (postponed from 26 May 2020 to 26 May 2021) and all the other references to that date in the MDR-related transitional provisions, together with immediate application of the possibility of EU-wide derogations, as envisaged by Article 59(3) MDR.

These changes have yet to come into effect. In order for them to do so, it is necessary for the MDR amendment to be published in the Official Journal of the European Union, by the end of April as planned.

Despite this, with the vote on 17 April, the last major political step in the legislative co-decision process has been taken, so the postponement of the date of application of the MDR to 2021 is to be considered as definitive.

However, in our case, the delayed application of the MDR 2017/745 results in no changes to the program and the process of review of the Technical Dossiers and the certifications already planned for our entire product range.

Our plans

In detail, our plan is:

• for our entire company quality system, starting with the Manual and including all internal procedures and processes, to be already in line with and operational according to the dictates and requirements of the new MDR 2017/745;
• for all Moretti products to have the unique device identification (UDI) code, and for the code to be indicated on the Declarations of Conformity issued;
• for all new products, as has been the case since the start of this year, to be certified exclusively according to the new requirements of the MDR 2017/745;
• for the review process of all documentation of the current products (technical dossiers, labelling, manuals and declaration of conformity) to proceed according to the initial plan, regardless of the delayed entry into effect of the new MDR.

In practical terms, this means that the majority of Moretti products will already be certified according to the requirements of the new MDR 2017/745 by May.

As a result of introduction of strict procedures of checks, quality controls and post-marketing surveillance, further and major attention will therefore be focused on product safety and quality for our entire product range.