5 things to know about medical devices compliance

From lead levels to producer’s responsibility, here’s what your company needs to know about keeping medical devices ahead of the compliance curve. 

Yujing Pan Picture 450

by Yujing Pan

As an essential element of product compliance, the safety of medical devices has always been a highly concerning topic.

Medical devices manufacturers are tasked with supplying medical devices with safety and high quality to consumers, whose health and lives are depending on such devices. This is done through the design, manufacturing, marketing, and end-of-life of medical devices. Here’s my list of key regulatory developments that medical devices suppliers need to pay attention to: 

1. New safety requirements for in vitro diagnostic medical devices

As an essential element of product compliance, the safety of medical devices has always been a highly concerning topic in the medical devices industry, and the world is certainly moving towards the direction of improving medical devices safety. 

The Federal Council of Switzerland adopted the Ordinance of 4 May 2022 on in vitro diagnostic medical devices, which sets out new safety requirements specific to the manufacture and placing on the market of in-vitro diagnostic medical devices. They could include a reagent, calibration material, control material, kit, instrument, apparatus, equipment, software, or system intended to be used in vitro for the examination of samples from the human body.  

Pursuant to the Ordinance, as of 26 May 2022, companies manufacturing, importing, or placing in vitro diagnostic medical devices on the market must comply with general safety and performance requirements. For example, manufacturers must affix the conformity marking “MD” on the device or packaging, and also on the instructions for use. They have also to establish, implement, maintain, and update a post-market surveillance system based on the risk class and type of the medical device.  

The Ordinance was adopted in order to align Swiss law with the new EU Medical Devices Framework, more specifically, the Regulation 2017/746 of 5 April 2017 on in vitro diagnostic medical devices, so that barrier-free market access and joint surveillance can be ensured between the EU and Switzerland. This development is the latest step in changes to the Swiss Medical Device Law aimed at better protecting patients and aligning with new European Union rules. 

2. Product compliance happens already during the manufacturing process

I once heard a presenter say “You cannot just test the safety in your final product, safety has to be manufactured into the product.” Good Manufacturing Practices (GMP) is enormously important to the manufacturing process because it is a system establishing minimum standards to ensure a level of quality, safety and strength in medical devices that are delivered to the public. 

While in some countries, such as the US, every manufacturer in the medical devices industry is required to maintain GMP compliance, some countries require such manufacturer to obtain a GMP certification.  

Starting 1 June 2022, specific companies manufacturing classes III and IV medical devices and placing them on the Brazilian market must hold a GMP certification issued by the Brazilian National Sanitary Surveillance Authority. Specific companies include, for example, those responsible for releasing the finished product, associated with at least 1 production phase. Before this date, the requirement of having a GMP certification applied only to companies manufacturing medical devices outside Brazil and other Mercosur countries, and it now applies to all manufacturers, regardless of their locations. 

To obtain the GMP certification, companies must, among others, companies must present to authority a specific petition form for GMP certification for medical devices duly certified and a general production flow chart.  

3. Producers’ responsibility doesn’t stop when the product is being sold

OECD defines Extended Producer Responsibility (EPR) as an environmental policy approach in which a producer’s responsibility for a product is extended to the post-consumer stage of a product’s life cycle. EPR seeks to transfer the environmental responsibility to producers as polluters and to effectively achieve higher environmental standards in product design. 

In France, producers have 2 options to fulfil their obligations under the extended producer responsibility (EPR) scheme: 

  • collectively set up approved eco-organisations for which they are responsible and to which they transfer their obligations by paying them a financial contribution; or 
  • set up an approved individual system to carry out their own obligations. 

Notably, as of 1 January 2023, companies manufacturing or importing perforating medical devices to France, which have set up an individual system under the EPR scheme, must comply with stringent collection and recycling targets. Companies which have transferred their obligations to an eco-organisation (by paying them financial contributions) must be aware that updated targets will apply.  

The French Order of 2 November 2022 introduces new collection targets of perforating medical waste of 82% in 2023 and 85% in 2025. It worth mentioning that in 2021, a quasi-stable collection rate of 82% was reached for perforating medical devices, and the target set for 2022 was 80%. 

New collection and recycling objectives are also set for waste electrical or electronic equipment associated with those perforating medical devices: 

  • a collection target of 50% in 2023, 55% in 2025 and 60% as of 2028; and 
  • a recycling target of 60% of collected waste in 2025 and 70% as of 2028. 

4. How much it costs when violating medical devices regulations

In line with many recent developments all over the world, India is tightening its enforcement measures for manufacturing and importing of medical devices. 

Medical Devices (Third Amendment) Rules, 2022 from India introduces stringent penal consequences for violations of license conditions and other requirements, for the first time in the Medical Devices Rules, 2017 (“MDR 2017”). Previously, companies were not subject to any penal provisions under the MDR 2017.  

This means, if the company, as a manufacturer or importer of medical devices, holds a license under the MDR 2017, it must strictly adhere to and ensure compliance with the conditions of the license and MDR 2017.  

Companies that violated the conditions of their license to manufacture, distribute or import medical devices and other relevant requirements could be subject to the following penal consequences:  

  • cancellation of license in whole or in part relating to a particular medical device; 
  • suspension of license in whole or in part relating to a particular medical device; 
  • direction to stop import, sale, and distribution of the medical device; or 
  • direction to destroy the medical device and the stock in presence of an authorized officer. 

Companies are however issued with a show-cause notice and an order that is subject to appeal before such consequences are fastened to the company. 

5. The journey of lead in medical devices continues

In a contrasting move, the EU proposed an amendment at the beginning of this year, at the EU level, an amendment was proposed at the beginning of this year, to add a new entry in Annex IV to Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment (the RoHS Directive). 

The proposal seeks to introduce an additional exemption for the use of lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of creatinine and blood urea nitrogen (BUN) in whole blood.  

Therefore, in the future, companies manufacturing and/or placing diagnostic medical devices on the EU market may be allowed to use lead in polyvinyl chloride for sensors used in the said devices following the eventual adoption of a draft Commission Delegated Directive introducing an additional exemption for the use of lead for the said applications under the RoHS Directive 2011/65/EU. If adopted, this exemption would apply until 31 December 2023. 

The RoHS Directive restricts the use of certain hazardous substances in electrical and electronic equipment (EEE), including lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE), bis (2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). 

However, Annexes III and IV to the RoHS Directive establish a list of exemptions from the above restrictions for specific applications, which can be modified for the purposes of adapting to scientific and technical progress. 

In particular, exemptions can be granted or renewed only if it does not weaken the environmental and health protection afforded by the REACH Regulation (EC) 1907/2006 and provided that: 

  • the elimination or substitution of the concerned hazardous substances is scientifically or technically impracticable; 
  • the reliability of substitutes is not ensured; or 
  • the negative environmental, health, and consumer safety effects caused by substitution are greater than the benefits thereof. 

Keeping your medical devices compliant

Regulators are raising the bar for the quality and safety of medical devices. And with so many new requirements evolving in parallel, manufacturers risk falling short simply due to blind spots in their compliance management. The key to staying aligned is staying ahead – and that is fully dependent on having a comprehensive view of what’s changing for your market. Read about what our clients said were their top challenges in the shifting landscape of EHS and sustainability in our survey research report.

Top 6 EHS and sustainability challenges for companies today