A leading European CRO, Regulatory & Quality System consultancy for medical devices, IVDs and drug-device combination products operating in the EU and US.
Your CRO partner for successful management of clinical studies in Europe, US and Canada for medical devices, IVDs and combination products.
Clinical Study Submissions
Clinical Study Submissions
High quality submissions to European and US regulatory authorities, plus negotiation of site agreements for medical device and IVD studies.
Regulatory and Quality
Regulatory & Quality
Expert assistance with any EU or US related regulatory or quality system issue for all types of medical device, including IVDs and combination products.
Extensive experience in developing high quality clinical evaluation reports and assistance with equivalence determination and device clinical data strategy.
Commission releases MDR/IVDR corrigenda
22 March 2019
The eagerly-awaited corrigenda for the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) have now been released by the European Commission.
To many in the industry, the revisions to the regulations will be disappointing, as they correct only typographic or other obvious errors in the original documents, without addressing any of the dozens of ambiguous requirements, which are already leading to different interpretations by manufacturers, notified bodies and competent authorities.
This result is despite the fact that the French competent authority ANSM published a report from a meeting with industry in which it went on the record saying that In addition to simple editorial corrections, it had been proposed to extend the transitional measures to Class I devices that newly require the use of a notified body or Class I devices that change class under the MDR, in order to avoid overloading NBs.
In the MDR corrigendum, there are 14 corrections, with some as simple as changing the word “trademark” to “trade mark” in Articles 2 and 7, or grammatical changes, while others, such as correction number 7, will mean that products of animal origins legally placed on the market prior to 26 May 2020 will not be allowed on the market after that transition date in such member states that previously allowed them.
The IVDR corrigendum, meanwhile, includes 17 corrections, with some minor tweaks that match the MDR changes, corrections of grammatical errors and others that may have more of an impact.
Preliminary SCHEER guidelines on phthalate benefit risk now available
21 March 2019
As reported in this news column on 1 March 2019, the European Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has now published its preliminary report on the benefit risk assessment (BRA) of phthalates in medical devices, following the committee's September 2017 acceptance of a request from the European Commission's Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. The full title of the document is 'PRELIMINARY version of the Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties'.
The document provides preliminary guidelines on the BRA of the presence in medical devices of phthalates which are currently alleged to have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction or endocrine-disrupting.
The guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices and/or parts or materials used therein at percentages above 0.1% by weight (w/w). The Medical Devices Regulation (MDR, 2017/745) permits such materials above 0.1% by weight (w/w) only "when justified" (MDR Annex I, Chapter II, point 10.4). Such a justification must be based on an analysis of potential patient and user exposure, availability of possible alternatives, an argumentation why possible alternatives are appropriate or inappropriate, and on the most recent SCHEER guidelines.
The preliminary document also considers the evaluation of possible alternatives for phthalates used in medical devices, and is intended to be used by stakeholders including manufacturers, notified bodies and regulatory agencies. The guideline states that it may also be used for BRAs of other CMR/ED substances in medical devices.
Pending new scientific evidence, the guidelines recommend that their use and usefulness are evaluated after an experience period of three years.
The guidelines offer no new scientific data relating to whether phthalates pose a credible risk to specific vulnerable patient populations, instead referring readers to the Committee's 2015 update to its report 'The safety of medical devices containing DEHP plasticized PVC or other plasticizers on neonates and other groups possibly at risk'.
The European Commission and SCHEER are holding a joint public hearing in Brussels on the Preliminary Guidelines on 4 April 2019. Interested parties will be invited to submit comments on the scientific evidence online before 29 April 2019, via an electronic template.