Medical Device Regulation

Environmental Issues

Environmental Obligations

Medical devices are subject to a range of environmental legislation. These are the laws that may impact medical devices:

Packaging and Packaging Waste (P&PW)

The Packaging and Packaging Waste Directive (94/62/EC) requires that:

  • Packaging is minimised
  • Packaging is designed for recovery and re-use
  • Recovery targets are met by the UK for waste packaging
  • Heavy metals in packaging are restricted.

The Directive has two components:

  • The first (Essential Requirements) looks at packaging’s composition. This must be kept to a minimum and, as far as possible be recoverable and recyclable. In this UK, this is the responsibility of BIS
  • The second (Producer Responsibility) looks at packaging recovery. Operators can meet their obligations through a Compliance Scheme. In the UK this is the responsibility of DEFRA.

All operators who pack their products must make sure they meet the requirements of Annex II to the P&PW Directive. To help manufacturers comply, the UK Government has provided guidance:

Environmental Issues

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

REACH is an EU Regulation. It is designed to protect human health and the environment from chemical and substance risk. In the long run, the intention is for most hazardous substances to be replaced with less dangerous ones.

Medical device manufacturers may need to seek expert advice on REACH to make sure they comply. This is a substantial and complex piece of legislation. It reaches right through the supply chain to the end user: i.e., it is not purely an issue for chemical manufacturers and importers. REACH impacts on most companies across the EU, whether they are users or producers. It applies to all chemical substances: from household cleaning products and paint to chemicals used in clothes, furniture and electrical equipment. This includes medical devices, although there are derogations in some circumstances.

The burden of proof is on companies. To comply, companies must identify and control the risks associated with the substances they manufacture and market in the EU. They have to show the European Chemicals Agency (ECHA) how the substance can be safely used. They must also communicate the risk management measures to users down the supply chain. If the risks cannot be managed, authorities can restrict the use of substances in different ways. Guidance on the REACH Regulation can be found here.

Classification, Labelling and Packaging of Substances (CLP)

The CLP Regulation works in parallel with REACH. It guides how users are warned about substance hazards, through standard symbols and phrases such as this symbol that tells users that a substance is flammable:

It brings the United Nations' Globally Harmonised System of Classification and Labelling of Chemicals (GHS) into EU legislation. Harmonising labelling and packaging ensures good worldwide understanding and helps facilitate the free flow of goods. The Regulation is also the basis for safety data sheets (SDS) which are regulated under REACH, and it sets requirements for the packaging of hazardous chemicals. Manufacturers of IVDs may be especially involved with this. Guidance on the CLP regulations can be found here.

Waste Electrical and Electronic Equipment (WEEE)

The Waste Electrical and Electronic Equipment Directive is “end of pipe” 'Producer Responsibility' legislation. It aims to protect the environment from discarded Electrical and Electronic Equipment (EEE). EEE can contain highly toxic and/or valuable materials and so WEEE aims for responsible recovery and recycling and/or the recovery of valuable/rare substances.

Anyone who markets EEE (including electrical Medical Devices) in the EU is covered by WEEE. Producers are expected to register and to keep records of the weight of EEE they place on a Member State market and then recover and ensure the environmentally sound disposal of a “proportionally equivalent” amount. Most Medical Device manufacturers do this through a 'Compliance Scheme'.

WEEE has 11 categories (Medical Devices are Category 8). In 2018, this will be updated and Medical Devices will fall into Cat 4 or Cat 5, depending on their size. UK guidance on the WEEE Producer Responsibility Obligations can be found here.

Restriction of Hazardous Substances (RoHS)

The RoHS Directive works in tandem with the WEEE Directive. It is “beginning of pipe” law and controls the substances that are used in Electrical and Electronic Equipment (EEE). It bans the use of six substances in EEE. This will rise to 10 on 22 July 2019. Exemptions are possible and are listed in Annex III and Annex IV of the Directive. They may be time-limited. UK guidance on the RoHS Directive can be found here.

Batteries and Accumulators and Waste Batteries and Accumulators

The Batteries Directive is a bit like a battery-specific version of the RoHS and WEEE Directives combined. Its objective is to promote battery efficiency through labelling. It makes sure that consumers know how much energy/capacity they are getting for their money. The aim is to eventually eliminate the use of hazardous substances in batteries and promote their environmentally sound recovery and disposal. It covers battery manufacturers, retailers, and anybody who supplies batteries by including them in their products.

As with WEEE, battery 'Producers' (above a certain threshold) are expected to keep a record of the quantity and chemistry (e.g. Ni-Cd, Li-ion) of the batteries they place on the market and to recover and dispose of them in an environmentally sound way, for a proportionally equivalent amount. Again, producers can discharge this obligation through a recovery scheme. The Directive also requires that batteries must be 'readily removable' from equipment, preferably by the user, though this may be delegated to a qualified person in some instances. There are exemptions to the requirement for readily removable in a limited number of situations.

UK guidance on Battery Producer Responsibility can be found here for waste batteries and here for placing batteries on the market.