New Medical Devices Regulation
On 26 May 2020, the new EU Regulation on Medical Devices 2017/745 (MDR) comes into force.
In December 2019, a four-year transitional period was agreed for certain medical devices that are currently classified as Class 1 under the Medical Devices Directive 93/42/EEC but will be upgraded to a higher risk class under the Medical Device Regulations.
To benefit from this transitional period, relevant medical devices must continue to comply with the applicable Medical Devices Directive requirements after 26 May 2020, and there must be no significant changes in the design or intended purpose of the medical devices.
Update to the Blue Guide on the implementation of product rules
Following a consultation that concluded on 15 January 2020, the European Commission is updating the Blue Guide – its guide to the implementation of certain directives relating to product regulation. The Commission has stated that the purpose of this update is to
- reflect new EU legislation and, in particular, Regulation 2019/1020 on market surveillance; and
- better cover the digital age and the circular economy.
Manufacturers, distributors and retailers should look out for the updated Blue Guide, as it is an invaluable source of guidance on EU product regulation.
Product regulation post-Brexit
Although the UK officially left the European Union on 31 January 2020, the UK is still bound by EU law and there are no changes to the product regulation regime until the end of the transition period on 31 December 2020 (unless extended).
Goods that are lawfully placed on the market in the EU or the UK before the end of the transition period may continue to freely circulate until they reach their end users without the need for modifications or re-labelling. When the transition period ends, unless there is an agreement to the contrary, the UK will be deemed a “third country” for the purposes of EU product regulation.
The practical effects of this will be more pronounced in certain sectors. For example, cosmetics manufacturers selling into the UK (including European manufacturers) will be required to have a responsible person who is established in the UK. This requirement is set out in pending UK legislation The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019.
In Focus | Responsible business
Which aspects of responsible business are driving the regulatory agenda?
Improving the overall sustainability of products is a prominent factor driving product regulation. The UK is looking to substantially reduce the use of single-use plastics. The supply of plastic straws, drinks stirrers and cotton buds will be banned in England (subject to certain exceptions) under the Environmental Protection (Plastic Straws, Cotton Buds and Stirrers) (England) Regulations 2020 which is due, in the main, to take effect from 6 April 2020.
With the circular economy becoming ever prevalent, there is a push for plastic products to be produced from more recycled plastic. The UK government has proposed a plastics tax on all packaging (produced in the UK or imported) that does not include at least 30% recycled material from April 2022.
The government’s approach to regulating plastics is rules-based with local authorities being given powers to issue undertakings, compliance notices or prosecute. Interestingly, local authorities will be able to issue Variable Monetary Penalties to offending organisations the total of which must not be greater than 10% of the organisation’s annual turnover in England. This could end up being be significant for many businesses.
Are responsible business considerations having an impact on the tools that regulators are using?
The government’s approach to regulating plastics is rules-based with local authorities being given powers to issue undertakings, compliance notices or prosecute. Interestingly, local authorities will be able to issue variable monetary penalties to offending organisations the total of which must not be greater than 10% of the organisation’s annual turnover in England.
Which of the recent or upcoming developments are based on international consensus or agreements?
There is an overwhelming international consensus on the reduction of single use plastics and improvements in the sustainability of products. The EU has various legislative and policy-driven initiatives to address the sustainability of products, including adopting a new directive which will ban single-use plastic plates, cutlery, straws, balloon sticks and cotton buds by July 2021. This goes further than the UK legislation, casting the net over a great amount of products. The EU also has its Strategy for Plastics in a Circular Economy which sets out its vision for a circular plastics economy. Measures introduced in the UK reflect these measures, specifically the tax on packaging which does not include at least 30% recycled material.
What are the main challenges for businesses in complying with these developments?
Businesses will need to be aware of the implications that incoming legislation could have on them and consider what steps they will need to take to comply with any new requirements.
If more products are brought within the ambit of the single-use plastic ban, this could have serious impacts resulting in businesses having to re-think how they sell products.
Producing products and packaging from recycled plastic tends to be more expensive than using virgin plastic. Businesses will need to consider the cost implications that this may have as it could squeeze margins.
Dates for the diary
|26 May 2020||Medical Devices Regulation applies, subject to the four year transition period for certain products described above.|
|1 January 2021 and 16 July 2021||EU Regulation 2019/1020 on increased market surveillance across the EU for non-food products comes into effect from 16 July 2021, with the exception of certain provisions that come into effect from 1 January 2021.|
|26 May 2022||In Vitro Diagnostic Medical Devices Regulation fully applies|