For Medical Devices in Europe Other than NLF, What Else is Applicable?

By Dasun Abey and Evangeline Loh

This series features EU legislation. There is the New Legislative Framework (NLF) and Blue Guide related to different products. The second article waxed philosophical about legislation gravitating towards Regulations. We wrote about the General Product Safety Regulation (GPSR) applicable to products for consumers in our third article.  

Regulatory Insight four discussed extensively the different NLFs and their relationship with medical devices and the Medical Devices Regulation (MDR 2017/745). If a product is both a medical device and machine, the Essential Safety and Health Requirements of the Machinery Directive must be assessed as well. If a product is both a medical device and personal protective equipment (PPE Regulation) or medical device and radio equipment (RE Directive (RED)), the PPE Regulation and RED, both must be assessed independently. For an electrical medical device, the device should be compliant with the RoHS Directive as well.

We continue to expound on medical devices and consider legislation other than the NLF.

Note the exclusions in the MDR

To be complete, it is important to recognize all the products explicitly excluded in the MDR. As described in Article 1(6), the following products are not medical devices (not a comprehensive list): in vitro diagnostic devices, medicinal products where medicinal is the principal mode of action, advanced therapy medicinal products, cosmetic products and food.

Hence, a purported “medical device” is not a medical device if the product is within the scope of the excluded provisions in Article 1(6).

What about Legislation Applicable to Substances (Chemicals)?

There is a sector within the European Commission Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs for Chemicals. Medical devices which are comprised of substances need to be compliant with the relevant substance legislation in the EU.

The two of note would be the Regulation on registration, evaluation, authorization and restriction of chemicals (REACH Regulation 1907/2006) and the Regulation on classification, labeling and packaging of substances and mixtures (CLP Regulation 1272/2008).

Applicable environmental legislation?

For electrical medical devices, there is the Directive on waste electrical and electronic equipment (WEEE), Directive 2012/19/EU. The WEEE Directive is related to RoHS Directive though interestingly was not inserted into the NLF. Directive 94/62/EC on packaging and packaging waste is also relevant.

Is there legislation related to software and data?

When the medical device collects and processes data related to EU patients, data protection must be considered. The General Data Protection Regulation (GDPR 2016/679) protects the processing of personal data and on the movement of the data. In the future, there will be an Artificial Intelligence Act.

Other legislative considerations

Navigating the regulatory requirements of a medical device requires knowledge of the EU legislation. Of course, if a product is a medical device, the legislation of primary concern is the MDR, though there are clearly other legislative considerations as well.