EU Legislation

Subscribe to EU Legislation

Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. The proposal does not introduce any substantive changes to the broader MDR but focuses on amending the transitional provisions in the MDR.

The proposed changes to the MDR transition provisions aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition from the former Directives to the MDR. This situation is currently threatening the availability of such devices within the EU market.…

Continue Reading European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation

It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group (MDCG) has now published guidance clarifying the use of the non-compliance procedure under Article 97 of the MDR.

Under Article 97, competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.…

Continue Reading New Guidance on the Application of Article 97 of the MDR to Legacy Devices Certified under the MDD or AIMDD

The European Commission intends to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) for an additional three years. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment. It is estimated that around 23,000 certificates of conformity for EU medical devices have not yet transitioned, which will expire on May 26, 2024 (if not before). Low notified body capacity is a key contributing factor for the transition delays.…

Continue Reading European Commission Announces Intention to Introduce Three-Year Extension to the MDR Transition Period

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 use of starting materials for innovative therapies, such as blood, tissues and cells.  Pharmaceutical companies active in the manufacturing of advanced therapy medicinal products (“ATMPs”) are therefore well advised to closely monitor the developments surrounding the proposed Regulation.…

Continue Reading European Commission to Harmonize Rules on the use of Substances of Human Origin

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?

This post originally appeared on our sister blog, InsideMedicalDevices.

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

This post originally appeared on our sister blog, InsideMedicalDevices.

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.

Scrutiny Procedure

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…

This post originally appeared on our sister blog, InsideMedicalDevices.

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

This post originally appeared on our sister blog, InsideMedicalDevices.

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.

Laboratory-Developed Tests

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