On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application. The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells. These sets of rules govern the sourcing and
Hannah Edmonds, a trainee associate in Covington’s London office, contributed to this post.
Currently, legal regimes governing protection of trade secrets and confidential information across the EU are fairly disparate. A study published by the European Commission in July (http://ec.europa.eu/internal_market/iprenforcement/docs/20130711/final-study_en.pdf) has identified a ‘widespread appetite for a harmonized approach’ across the region. Harmonisation of the rules could be of significant financial and practical benefit to life sciences companies.
Ensuring that sensitive information (such as customer supply lists, R & D data and process know how and technology) is legally protected from misuse by employees, consultants, competitors and other third parties is a key concern in the life sciences sector. ‘Trade secrets’ often form the bedrock of a company’s assets. 75% of the 537 EU firms who responded to the Commission’s preparatory survey (some of which were SMEs in the life science sector) indicated that trade secrets were of significant strategic importance to their company’s growth, competitiveness and innovative performance.
Continue Reading A Move to Harmonise Trade Secret Laws Across Europe?
Unlike in the US, medical devices in the EU are not subject to a premarket authorization by a competent authority but instead to a conformity assessment procedure. For low-risk devices, the manufacturer conducts this conformity assessment procedure, whereas for medium and high risk devices, independent third parties, so-called “Notified Bodies,” are involved.
What are Notified Bodies?
Notified Bodies are entities that have been accredited by the competent authority of a European Member State to assess the conformity of the products with the relevant EU legislation. Their legal status varies from public bodies to associations and commercial undertakings. Today, 29 EU legislative regimes are implemented in practice by the involvement of Notified Bodies. These regimes include the rules on personal protective equipment, marine equipment, toys, and machinery. For medical devices, 78 Notified Bodies have been designated for the assessment under one of the three Directives currently regulating medical devices in the EU,i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices, and Directive 98/79/EC on in vitro diagnostic medical devices (IVDs).
Continue Reading “Notified Bodies” Under EU Device Regulations: Under Stricter Control But With More Power
Following recent developments regarding breast implants and metal-on-metal hip joint replacements, the European Parliament (EP) adopted a resolution calling for safer medical devices and the introduction of a marketing authorization system for high-risk devices. While the Commission has not endorsed the EP’s resolution for a premarket authorization system in its Proposal for a new EU medical devices’ regulation, described in our previous post, it still had to take into account the strong call from the public for safer and more strictly controlled medical devices. As a result of this political imperative, the Commission included in Article 44 of its Proposal a so-called “scrutiny procedure.” Like the rest of the Proposal, the scrutiny procedure would become law if adopted by the European Parliament and the Council. Our earlier post on the legislative process describes this procedure in more detail.
Under the scrutiny procedure, any new applications for conformity assessment of high-risk devices (with the exception of applications to supplement or renew existing certificates) would now possibly be subject to a “second look” by the Medical Devices Coordination Group (MDCG). This newly created expert committee would be composed of Member State officials and chaired by the European Commission. The Commission will probably also develop some centralized scientific and technical expertise that will allow it to be more directly involved in the assessment of specific products.
Continue Reading EU Proposes a Scrutiny Procedure for High-Risk Devices
Article originally published in the FDLI Update (January/February 2013)
“Being able to use innovative products at the earliest possible time – and in Europe we deliver innovation about three years before our American counterparts with their own system – is a benefit to patients that we cannot put aside.” This is how former European Union…
The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical Devices Directive 93/42/EEC (MDD).
Case C-219/11 Brain Products GmbH V BioSemi VOF and Others, concerned the product ActiveTwo, a “biopotential measurement system” that records electrical signals from the brain, heart and muscles, manufactured and is marketed by Dutch company BioSemi. ActiveTwo is not designed for use in any medical diagnosis or treatment, but is used by researchers for clinical investigation of cognitive sciences. BioSemi’s website and promotional material state that the product is “not designed or intended to be used for diagnosis or treatment of disease.” As such, BioSemi argued that the ActiveTwo was not a medical device and so did not require CE-marking.
Continue Reading CJEU Clarifies Medical Device Borderline
The European Commission has proposed a revision to the regulatory framework for in vitro diagnostic medical devices (IVDs) that could have a significant impact on the operations of commercial laboratories in the EU or those offering testing services to customers in the EU.
Under current EU rules, laboratory-developed tests (colloquially known as “home brew” tests) meet the definition of an IVD. However, there is an exemption from the requirements under the current IVD Directive for certain laboratory-developed tests: Article 1(5) excludes from the scope of the Directive devices“manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity.” ‘Health institution’ is not defined by the Directive, leading to significant variation in interpretation at the member state level as to when this exemption should apply, particularly in its application to free-standing commercial laboratories.
Continue Reading Proposed EU Rules Impact Commercial Testing Laboratories
After more than 40 years of discussions, the European Parliament today voted in favour of the “EU patent package,” hot on the heels of the European Council’s approval yesterday. The EU patent package will create a Unitary EU Patent i.e. a uniform patent which will have equal effect and will be granted, transferred and enforced in a unitary way in most of Europe. Unitary EU Patents will be granted through the existing European Patent Office, but a new court system will be set up to enforce these patents.
The Unitary EU Patent will, in time, replace the current system of European Patents which – after grant – operate as independent national patents in up to 38 countries.
Continue Reading A Unitary Patent for Europe is Finally Approved
The publication by the European Commission of two proposals for the revision of the EU regulatory framework for medical devices in September has initiated the legislative process which will ultimately lead to the adoption of the final EU Regulations on medical devices. The proposals have been transmitted to the European Parliament and Council for their consideration.
At the European Parliament, the proposals have been assigned to the ENVI parliamentary Committee, responsible for environmental and public health matters. Two German Members of the European Parliament have been appointed as “rapporteurs”, i.e., leaders of the parliamentary process: Mrs. Dagmar ROTH-BEHRENDT from the Socialists and Democrats’ group for the Regulation on medical devices and Mr. Peter LIESE from the Christian-democrats for the Regulation on IVDs. Once adopted within the ENVI Committee, the reports will be sent to the consideration of the entire European Parliament, which will adopt its position on the legislation. While the parliamentary work should begin early next year, the European Parliament’s plenary vote is currently expected for September 2013.
Continue Reading New Regulations for Medical Devices in Europe: Overview of the Legislative Process
On September 26, 2012 the European Commission adopted its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro…