Medical Devices | Monthly bulletin | October 2019

Europe

Final version of the SCHEER’s guidelines on phthalates in medical device

As already announced in our Eurofins News Flash April 2019 edition, in March 2019, the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) opened a Public consultation on the Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.

In September 2019, SCHEER published the final version of these guidelines on the benefit-risk assessment of the presence of Phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.

Click here for getting more information from European Commission’s website.

Some cosmetic and aesthetic products become Medical device

On 26^th May 2020, the new regulations for medical devices will be fully applicable. At first we could think that it does not affect cosmetic products, but this is not the case. According to Annex XVI of the Medical Device Regulation (EU) 2017/745, the following cosmetic and aesthetic products have been redefined as medical devices:

• Colored contact lenses
• Liposuction equipment
• Collagen implants
• Tattoo removal equipment
• Dermal fillers
• Laser or Intense Pulsed Light (IPL) hair removal equipment
• Skin resurfacing equipment

Affected manufactures, importers and distributors will have to meet CE mark certification requirements and maintain certification. The main points of medical device regulation compliance are:

• CE Mark
• CE certification
• Classifying their products according to the regulation
• Partnering with a designated Notified Body
• Implementing a quality management system (EN ISO 13485:2016)
• Companies with no physical presence in the EU will need to appoint a European Authorized Representative for in-country representation
• Risk management plan
• Post-market surveillance requirements
• Clinical evaluation reporting

Preparations for BREXIT

The next 1^st November 2019 will be the withdrawal date in which UK will leave the European Union.

On 4^th September 2019, the European Commission published the report with reference COM/2019/394 final:

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN CENTRAL BANK, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE, THE COMMITTEE OF THE REGIONS AND THE EUROPEAN INVESTMENT BANK.

Finalising preparations for the withdrawal of the United Kingdom from the European Union on 1 November 2019.

UK Notified Bodies indicate that the transfer of medical devices certificates to EU Notified Bodies is well underway and, for the vast majority of devices, expected to be completed by 31 October 2019. But there are still manufacturers that have not taken all the measures needed for this transfer.

Remaining manufacturers and UK notified bodies are encouraged to ensure that the transfer of all certificates and the product label adaptations are completed by the withdrawal date so that manufacturers can continue to sell their products in the EU market.

Recent publications by European Commission

Below you will find a Decision recently published in the Official Journal of the European Union related to Medical Devices:

Regulatory proposals notified to WTO

Below a summary table with some recent notifications to World Trade Organization (non-exhaustive):

Europe/International

Standards Updates

Below a summary table with some recent standards updates and upcoming dates of withdrawal (non-exhaustive):

(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.