CE marking: between transition period, overwhelmed notified bodies and timelines of 12 to 18 months, medical device manufacturers are facing a race against the clock. Key figures and deadlines to know.
Obtaining CE marking has become a real race against the clock. Currently, with the transition period of European Regulation 2017/745 on Medical Devices (MDR) and overwhelmed Notified Bodies (NB), the time required to obtain this marking ranges between 𝟭𝟮 𝗮𝗻𝗱 𝟭𝟴 𝗺𝗼𝗻𝘁𝗵𝘀.
A closer look at the transition period 🔎
• High-risk MDs (class III and certain IIb): transition until 31 December 2027.
• Medium and low-risk MDs (certain IIb, IIa, I, and sterile class I or with measuring function): transition until 31 December 2028.
• If the MD class becomes higher than I, an assessment by a Notified Body is required. Manufacturers must therefore contract with a Notified Body before September 2024 and have a Quality Management System (QMS) compliant before May 2024.
Notified Body bottleneck 📊
According to a European Commission survey:
• In March 2023, 𝟭𝟭,𝟰𝟭𝟴 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 for CE marking were submitted, but only 𝟮,𝟵𝟱𝟭 𝗖𝗘 𝗰𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗲𝘀 under the MDR were issued.
• The average time to obtain a new certificate for QMS submissions is 6 months. For QMS and Technical Documentation (TD) submissions, the timeline largely exceeds 6 months.
Faced with these challenges, urgency is the order of the day for medical device manufacturers. It is essential to stay informed, get organised and act without delay.
CE marking is a real race against the clock!
A wait of 12-18 months for approval by Notified Bodies.
11,418 applications submitted, 2,951 certificates issued.
Anticipating is essential in this context.
