Regulatory Open Forum

Dear Community,<o:p></o:p>

On 1 August 2023, the UK government published its decision to extend allowing CE marking indefinitely. For most of the product categories, this will mean they don't have to go through UKCA certification if they are already CE certified. Some product categories are not included, among them medical devices and IVDs. In my view, it is only a matter of time before CE marking will be allowed indefinitely for these devices. The reason for that is, that the decision to keep allowing CE on products placed on the Great Britain market will put UK Approved Bodies out of most of their business overnight, and manufacturers have been investing in UKCA marking of their products wasted a lot of money. Considering the capacity issues the EU is facing with notified bodies in the MedTech industry, it can be expected that Great Britain will have an even bigger certification problem unless UKCA marking becomes a rubber stamping exercise. <o:p></o:p>

My educated guess about what to do is that manufacturers of medical devices and IVDs should wait with their UKCA certification until it is crystal clear what is going to happen. And even then, it may be a smart strategy to avoid being the first to certify for UKCA. Under current chaotic conditions, it cannot be expected that the industry anticipates on wishful thinking of politicians. <o:p></o:p>

Hello there,

I saw that too Ronald and just went ... ho-hum :).  I definitely, strongly agree with your recommendation waiting until MHRA have clearly identified what is happening with UKCA certification to medical devices and IVDS and when/if the new regulation being published.  As I have been telling companies for some time now, there is a current regulation from 2002 (with some amendments) but without a clear path on the new regulation, it would be prudent to be patient.

Dear Community,<o:p></o:p>

On 1 August 2023, the UK government published its decision to extend allowing CE marking indefinitely. For most of the product categories, this will mean they don't have to go through UKCA certification if they are already CE certified. Some product categories are not included, among them medical devices and IVDs. In my view, it is only a matter of time before CE marking will be allowed indefinitely for these devices. The reason for that is, that the decision to keep allowing CE on products placed on the Great Britain market will put UK Approved Bodies out of most of their business overnight, and manufacturers have been investing in UKCA marking of their products wasted a lot of money. Considering the capacity issues the EU is facing with notified bodies in the MedTech industry, it can be expected that Great Britain will have an even bigger certification problem unless UKCA marking becomes a rubber stamping exercise. <o:p></o:p>

My educated guess about what to do is that manufacturers of medical devices and IVDs should wait with their UKCA certification until it is crystal clear what is going to happen. And even then, it may be a smart strategy to avoid being the first to certify for UKCA. Under current chaotic conditions, it cannot be expected that the industry anticipates on wishful thinking of politicians. <o:p></o:p>

Dear Community,<o:p></o:p>

On 1 August 2023, the UK government published its decision to extend allowing CE marking indefinitely. For most of the product categories, this will mean they don't have to go through UKCA certification if they are already CE certified. Some product categories are not included, among them medical devices and IVDs. In my view, it is only a matter of time before CE marking will be allowed indefinitely for these devices. The reason for that is, that the decision to keep allowing CE on products placed on the Great Britain market will put UK Approved Bodies out of most of their business overnight, and manufacturers have been investing in UKCA marking of their products wasted a lot of money. Considering the capacity issues the EU is facing with notified bodies in the MedTech industry, it can be expected that Great Britain will have an even bigger certification problem unless UKCA marking becomes a rubber stamping exercise. <o:p></o:p>

My educated guess about what to do is that manufacturers of medical devices and IVDs should wait with their UKCA certification until it is crystal clear what is going to happen. And even then, it may be a smart strategy to avoid being the first to certify for UKCA. Under current chaotic conditions, it cannot be expected that the industry anticipates on wishful thinking of politicians. <o:p></o:p>

Dear Community,<o:p></o:p>

On 1 August 2023, the UK government published its decision to extend allowing CE marking indefinitely. For most of the product categories, this will mean they don't have to go through UKCA certification if they are already CE certified. Some product categories are not included, among them medical devices and IVDs. In my view, it is only a matter of time before CE marking will be allowed indefinitely for these devices. The reason for that is, that the decision to keep allowing CE on products placed on the Great Britain market will put UK Approved Bodies out of most of their business overnight, and manufacturers have been investing in UKCA marking of their products wasted a lot of money. Considering the capacity issues the EU is facing with notified bodies in the MedTech industry, it can be expected that Great Britain will have an even bigger certification problem unless UKCA marking becomes a rubber stamping exercise. <o:p></o:p>

My educated guess about what to do is that manufacturers of medical devices and IVDs should wait with their UKCA certification until it is crystal clear what is going to happen. And even then, it may be a smart strategy to avoid being the first to certify for UKCA. Under current chaotic conditions, it cannot be expected that the industry anticipates on wishful thinking of politicians. <o:p></o:p>

I think this can also be seen as a prisoners dilemma. Suppose MHRA announces new regulations, including a deadline for UKCA certification to become mandatory. Manufacturers that go for early certification have the most certainty of becoming UKCA certified. However, if enough manufacturers wait until the very end, this may allow CE on the UK market for an extended period, maybe even permanent. <o:p></o:p>

<o:p> </o:p>

For now, I get the feeling most companies are tuning down their UKCA investments. RAPS colleagues, what do you think?<o:p></o:p>

Dear Community,<o:p></o:p>

On 1 August 2023, the UK government published its decision to extend allowing CE marking indefinitely. For most of the product categories, this will mean they don't have to go through UKCA certification if they are already CE certified. Some product categories are not included, among them medical devices and IVDs. In my view, it is only a matter of time before CE marking will be allowed indefinitely for these devices. The reason for that is, that the decision to keep allowing CE on products placed on the Great Britain market will put UK Approved Bodies out of most of their business overnight, and manufacturers have been investing in UKCA marking of their products wasted a lot of money. Considering the capacity issues the EU is facing with notified bodies in the MedTech industry, it can be expected that Great Britain will have an even bigger certification problem unless UKCA marking becomes a rubber stamping exercise. <o:p></o:p>

My educated guess about what to do is that manufacturers of medical devices and IVDs should wait with their UKCA certification until it is crystal clear what is going to happen. And even then, it may be a smart strategy to avoid being the first to certify for UKCA. Under current chaotic conditions, it cannot be expected that the industry anticipates on wishful thinking of politicians. <o:p></o:p>