News

EU MDR Update – Dental Implants Added to the List of Well-Established Technologies (WET)

On 29 June 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/1451, updating the list of Well-Established Technologies (WETs) eligible for the clinical investigation exemption provided under the Medical Device Regulation (EU) 2017/745 (MDR).

Is Your Biocompatibility Strategy Still Compliant?

ISO 10993 Gap Analysis & Biocompatibility Assessment Servicen

Maytal and PHTA Partner to Accelerate the Commercialisation of Medical Device Innovation

Maytal, an international regulatory consultancy specialising in medical devices, in vitro diagnostics and life sciences, has entered into a strategic partnership with the University of Birmingham's Precision Health Technologies Accelerator (PHTA) to support the next generation of medical technology innovators.

EUDAMED registration: November is around the corner!

EUDAMED Device Registration Support: We Handle the Entire Process, No Internal Resources Required

Maytal Attending EBME Expo 2026 in Coventry

Maytal will participate in the Med-Tech Innovation Expo 2026

Maytal will be attending Med-Tech Innovation Expo 2026, taking place at the National Exhibition Centre in Birmingham on 3 and 4 June 2026, to develop new collaborations and strengthen partnerships in the UK medical device and regulatory sectors.

Implementing Regulation (EU) 2026/977

A technical update on paper. A structural shift in compliance in practice.

Maytal will participate in the Expodental Meeting 2026

Maytal is pleased to announce its participation in the Expodental Meeting in Rimini, Italy, May 14-16, 2026, the leading trade show for the dental industry.

Clinical Investigation: Is It Always Required?

How many regulatory decisions are you making “just to be safe”… instead of strategically? Under Regulation (EU) 2017/745, we see it every week: companies launching clinical investigations… when they could actually avoid them.

Regulatory Compliance for South East Asia

Maytal is excited to share an important strategic development in our March 2026 newsletter: we are actively exploring expanded opportunities in regulatory compliance for medical devices and in vitro diagnostics (IVD) across Southeast Asia.