By Clark A Belanger
Physicians rely on scientific data to make judgments regarding the treatment of their patients. In the context of medical devices, health-care professionals require access to information regarding specific devices in order to make objective determinations on the safety and clinical efficacy of specific devices for certain patients. Evidence submitted by medical device manufactures to governing bodies, when seeking approval for individual devices, should be publicly available for review by both physicians and patients. Without access to this information, physicians cannot make informed determinations regarding the use of specific medical devices.
Regulations 2017/745 and 746:
On April 5, 2017, the European Union adopted new regulations on medical devices. These regulations entered into force on May 25, 2017. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter, Regulation 2017/745) aims to improve the transparency of medical device information available to physicians and patients. Regulation 2017/746 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter, Regulation 2017/746) improves access to information for in vitro diagnostic medical devices. Both regulations were adopted with broad support in the EU, with the hope of establishing a more modernized and robust legislative framework to improve public health and patient safety.
The new regulations provide a comprehensive system aimed to improve access to medical device information. Regulation 2017/745 creates a new pre-market scrutiny mechanism with the involvement of several experts to provide stricter ex-ante control for high-risk devices. Further, it reinforces the criteria for designation and processes for oversight of notified bodies. Regulation 2017/746 introduces a new risk classification system for in vitro diagnostic medical devices in line with international guidance. However, the most notable improvement to the transparency of medical device information is the establishment of a comprehensive EU database on medical devices (Eudamed) and of a device traceability system based on Unique Device Identification. This advancement is set forth in Regulation 2017/745, Recital 43:
Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Concerns with the New Regulations:
Furthermore, Article 32 of Regulation 2017/745, provides that manufacturers of implantable and high-risk (class III) medical devices must prepare a summary of safety and clinical performance (SSCP) for their device, which is to be publicly available via the new Eudamed system. The regulation contains a set of minimum specifications regarding the contents and data elements that must be included in the SSCP. The goal of this provision is to ensure that all clinical investigations are recorded and reported and that these clinical investigation reports will be publicly available to physicians and patients. However, this provision applies only to trials that have been conducted in the EU. While the hope is that these records will provide adequate detail to enable physicians and health-care professionals to make informed decisions, there is some skepticism concerning the lack of information about clinical trials conducted outside of the EU. If true, this skepticism poses serious concerns relating to the new Regulation’s ability to satisfy Article 168 of the Treaty on the Functioning of the EU. Article 168 provides that, “[a] high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.” Moreover, the Court of Justice of the EU has held that Article 168 provides that a high level of health protection must be “guaranteed.” If a high level of health protection requires disclosure of all medical device evidence concerning safety, performance, and effectiveness, then physicians and health-care professionals should have access to all evidence from clinical investigations, regardless if trials were conducted outside of the EU.
There are also concerns that Regulation 2017/745 also limits transparency by emphasizing the need for confidentiality of certain information, particularly in Articles 12, 73, 92, and 109. Long standing European Medicines Agency (EMA) policy holds that disclosure in the public interest is superior to any argument for confidentiality. Three recent judgments by the General Court of the EU, concerning access to market authorization (MA) data, confirm that the EMA’s policy position is supported by the EU rules on transparency and access to information. The verdicts released by the General Court serve to not only confirm the EMA’s policy position, but also shed light on the tension between transparency and confidentiality in the context of medical device information. There are three main takeaways from the recent judgments of the General Court. First, all three judgments hold that there is not a presumption in favor of confidentiality for clinical studies. In other words, the person claiming confidentiality has the burden of establishing the need for confidentiality of any document, or of information contained in any document. Second, the judgments hold that the publication of certain information in a publicly available European Public Assessment Reports (EPARs) does not mean that information not published in any EPAR is confidential. Third, the judgment in Case T-235/15 holds that the information contained in an EPAR “cannot in itself satisfy the requirement of transparency laid down in Regulation No 1049/2001. In the field of medicinal products, that requirement of transparency is justified by the need for supervision of the EMA's activities and, in particular, . . . the issuing of an MA.”
One additional hurdle exists in the way that EU member states will make information about the inspection of notified bodies publicly available. Under the new regulations, a member state may retain documents that relate to the approval of medical devices, which are consequently not transmitted to Eudamed. These documents are governed by the freedom of information laws of the individual member states. Due to the diverse national rules and language barriers, the various member states’ freedom of information laws will not solve the problem of general access to medical device information.
 Alan G Fraser, et. al., The Need For Transparency Of Clinical Evidence For Medical Devices In Europe. The Lancet, Vol. 392, Issue 10146. July 13, 2018, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31270-4/fulltext.
 European Commission, Medical Devices: Regulatory Framework, Aug. 31, 2018, https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en.
 Official Journal of the EU, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter Regulation 2017/745).
 Official Journal of the EU, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (hereinafter Regulation 2017/746).
 European Commission, supra note 3.
 Regulation 2017/745, supra note 5.
 Regulation 2017/745, supra note 6.
 Regulation 2017/745, supra note 5, at Recital 43.
 Id. at Art. 32.
 Fraser, supra note 1.
 Consolidated Version Of The Treaty On The Functioning Of The European Union, Art. 168, Oct. 26, 2012, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=EN.
 Court of Justice of the EU, Judgment of the Court (Second Chamber), May 4, 2016. Philip Morris Brands SARL and others v. Secretary of State for Health. Case C-547/14.
 Regulation 2017/745, supra note 5, Art. 12, 73, 92, 109.
 European Medicines Agency, General Court Confirms EMA Approach To Transparency—Three Rulings Clarify The Scope Of Commercial Confidentiality With Regard To Authorized Medicines, EMA/73690/2018, Feb. 6, 2018,
 General Court of the EU, Judgment of the General Court (Second Chamber, Extended Composition) of Feb 5, 2018, Pari Pharma GmbH v. European Medicines Agency, Case T-235/15,
http://curia.europa.eu/juris/document/document_print.jsf?doclang=EN&text=&pageIndex=0&part=1&mode=lst&docid=199041&occ=first&dir=&cid=249920; General Court of the EU, Judgment of the General Court (Second Chamber), Feb 5, 2018, PTC Therapeutics International Ltd v. European Medicines Agency, Case T-718/15,
http://curia.europa.eu/juris/document/document_print.jsf?doclang=EN&text=&pageIndex=0&part=1&mode=lst&docid=199044&occ=first&dir=&cid=249920; General Court of the EU, Judgment of the General Court (Second Chamber), Feb 5, 2018, MSD Animal Health Innovation GmbH and Intervet international BV v. European Medicines Agency, Case T-729/15, http://curia.europa.eu/juris/document/document_print.jsf?doclang=EN&text=&pageIndex=0&part=1&mode=lst&docid=199042&occ=first&dir=&cid=253401.
 Pari Pharma GmbH, supra note 24.
 Regulation 2017/745, supra note 5, Art. 35.
 Fraser, supra note 1.