The Medical and In Vitro Diagnostic Medical Devices regulations (MDR and IVDR) have been published on May 5th, 2017 in the Official Journal.
The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current Medical Device Directive 93/42/EEC, the EU’s directive on Active Implantable Medical Device 90/385/EEC, and the In Vitro Diagnostic Directive 98/79/EEC.
Within the last few years, the Medical Device industry has witnessed a series of changes. The last one took place on April 5th, when the EU Parliament concluded years of tractions and discussions with the vote of the Medical Device and In Vitro Diagnostic Regulations.
What began in 2012 at the initiative of the European Commission came to an end during the plenary session of April 5th, 2017, with the adoption by the European Parliament of the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR).
The Medical Device Industry has always been one of the most demanding when it comes to satisfying its stakeholders.
Satisfying and embracing the needs of multiple actors (market evolution, patient safety, investors, regulators and supply chains) has obligated Legal Manufacturers of medical devices to adapt to change in order to remain viable and in demand.
The Council of the European Union announced the publication on Wednesday February 22nd, 2017 of the final draft version for the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Both texts, respectively 566 pages and 477 pages, have been long-awaited and are now available for consultation.
With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used.
Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.
Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.
The certification audit is a though exercise and a major step for Medical Device Manufacturers looking to access a targeted market.
If you are looking to launch your company and your products or simply step into the world of the medical device industry, then be sure to thoughtfully plan and prepare your initial certification audit.
LNE/G-MED in this edition of the February newsletter, is discussing the most common pitfalls observed during a company’s first audit, pitfalls which may delay or simply prevent the company’s access to market.
Based on our experience with ISO 13485 and CE marking audits, most of these topics lead to major non-conformities ( NCs ) which need to be fixed prior to obtaining Certificates and that could therefore impact the certification timeframe.