The European Commission published a Proposal for a Regulation on Packaging and Packaging Waste (the Proposed Regulation) to tackle the growing amount of packaging waste, the low levels of recyclability, and the re-use and uptake of recycled content. If adopted, the rules will apply to all companies involved in the packaging life cycle that place packaging and packaging waste in the EU internal market regardless of whether these companies are based in the EU.  While there are various exceptions for manufacturers of medicinal products and medical devices sectors, if adopted, the Proposed Regulation will require life sciences companies to make significant amendments to their current and future product packaging, with resulting cost impacts. We set out the key requirements and takeaways from the Proposed Regulation in our Advisory, and will continue monitoring and reporting on new developments as the legislative process evolves.

We have also prepared this helpful summary for your reference. Continue Reading Proposal for Revision of EU Legislation on Packaging and Packaging Waste

New EU rules under chemicals and waste legislation require manufacturers and suppliers of products to provide information to a centralized EU database.  These rules may also affect the medical devices industry.

SCIP database

Since 5 January 2021, a new obligation to notify the European Chemicals Agency (“ECHA”) applies to suppliers of articles containing substances of very high concern (“SVHCs”) in a concentration above 0,1 % weight by weight (w/w). The obligation is established under the revised Waste Framework Directive 2008/98/EC (“WFD”) which cross-references Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (“the REACH Regulation”) and provides the basis for the creation of a new database collating information on “Substances of Concern In articles as such or in complex objects (Products)” (known as “the SCIP database”) to which notifications must be submitted under the supervision of ECHA (Article 9 of WFD).

According to ECHA, the aim of the new notification obligation is to ensure that information on SVHCs is available throughout the whole lifecycle of articles and materials, including the waste stage. SVHCs are hazardous substances (e.g., carcinogenic, mutagenic or toxic for reproduction) included in the Candidate List for authorisation of the REACH Regulation. Information submitted to the SCIP database will be accessible to national authorities, waste treatment facilities, supply chain operators and consumers. ECHA intends to publish the submitted information as received, unless the protection of confidential business information can be justified.
Continue Reading EU Chemicals: Obligation to notify ECHA on hazardous substances and its impact on the medical devices industry

Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.Continue Reading Medical Devices and Compulsory Insurance in the EU

RoHS refers to Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (EEE). It is illegal to place EEE products on the market that are non-compliant with RoHS, and doing so risks criminal prosecution, with potentially unlimited fines on conviction.

The original RoHS legislation was made in 2003. Under RoHS, EEE must not contain the restricted substances, which comprised lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). Only trace amounts, no higher than the specified “maximum concentration value by weight in homogeneous materials” may be tolerated. There are also exemptions for certain uses.

Now, Directive 2015/863, which updates RoHS, has added four phthalates (chemicals typically used to soften plastic) to the restricted list from 22 July 2019: butyl benzyl phthalate (BBP), di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP).Continue Reading RoHS: EU Phthalate Restrictions in Electrical and Electronic Equipment

On 12 November 2018 the EU Commission announced that its rapid alert system formerly known as ‘RAPEX’ is being updated and rebranded as ‘Safety Gate’.  Aside from the rebranding, the main new features of the Safety Gate platform are that it is more accessible to consumers, being now available in 25 languages, and it is capable of being shared by consumers via social media.

With certain exceptions, this online product safety database covers dangerous non-food products.  It includes cosmetic products, but not medicines or medical devices.  It is populated by alerts of potentially serious risks posed by such products.  In line with applicable EU legislation, economic operators are required to notify risks presented by products that they have placed on the market in the EU to the competent national authorities in the Member States in which the affected products have been sold.  The legislation requiring such notification is the General Product Safety Directive, or sector-specific legislation with similar effect, such as the legislation applicable to toys and electrical goods, as implemented in each Member State.  The legislation also obliges operators to take corrective actions, such as product recall, if appropriate.Continue Reading EU Safety Gate

On 12 October 2018, the MHRA issued Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) providing guidance on the expansion of scope of the medical devices regime to include certain products which had been previously unregulated at EU level.

Article 1(2) of the Medical Devices Regulation (MDR), in force from 25 May 2017, explains that the MDR will regulate “certain groups of products without an intended medical purpose” as though they were medical devices.

There are currently six types of products in this category which are listed at Annex XVI of the MDR.Continue Reading New MHRA guidance on non-medical devices

Judgment was handed down on 21 May in the DePuy Pinnacle Metal on Metal Hip group litigation: Gee & Others v DePuy International Limited [2018] EWHC 1208 (QB)

312 claimants in the group litigation brought claims against DePuy, alleging that the hip prostheses with which they had been implanted were defective for the purposes of the Consumer Protection Act 1987 (the Act) and the Product Liability Directive 85/374/EC (the Directive). The judgement followed a trial at first instance of a common preliminary issue, namely “whether or not the defendant is liable to the claimant, subject to any development risk defence.” The preliminary issue encompassed questions of causation.Continue Reading England & Wales High Court Judgment in metal on metal hip group litigation

EU Life Sciences: Product Liability Update

Please join us on 28 November 2017 for our Product Liability Update. This full-day seminar will provide in-house counsel with key insights into the latest developments in product liability and related areas in the context of medicinal products and medical devices. Our EU Life Sciences team will discuss issues