Regulatory Affairs

If you are a medical device or in vitro diagnostics (IVD) manufacturer based outside the UK, it is a regulatory requirement to appoint a UK Responsible Person (UKRP) to place your product on the market in Great Britain (England, Wales and Scotland). 

If you are unsure as to whether you require a UKRP, please reach out to us and would be happy to assist you.

Yes! Navigating the transition from the Medical Device Directive (MDD) to the more stringent Medical Device Regulation (MDR) can be a complex journey, but our dedicated medical device consultancy is here to guide you through every step. 

With a comprehensive understanding of the evolving European regulatory landscape, we specialise in facilitating a seamless transition, ensuring your compliance with the latest MDR requirements. 

Our experienced team brings unparalleled expertise to reclassify devices, address increased clinical requirements and adapt to changes in notified bodies. Partnering with us means strategic planning tailored to your unique needs, allowing you to meet crucial deadlines and successfully navigate the intricacies of the MDD to MDR transition. 

The UK Conformity Assessment (UKCA) is the new product marking for medical devices entering the market in Great Britain. It is designed to require devices to obtain a conformity assessment certificate from an Approved Body, in order to demonstrate compliance with the UK MDR 2002.

While it may be similar to the EU’s CE Marking requirements, the UKCA means many will now need to relearn the requirements for manufacturing medical devices. We can help with this, so please reach out if you need further advice.

CE Marking shows that a medical device demonstrates compliance with EU medical device regulations and meets essential standards. It requires devices to obtain a conformity assessment certificate from a Notified Body and demonstrate compliance with the EU MDD/MDR or IVD/IVDR. 

The UK currently accepts both the UKCA and CE Marking. The Medicines and Healthcare products Regulatory Agency (MHRA) will also continue to recognise European CE Marking in Great Britain until between 2028 and 2030, depending on the type of CE Marking.

In the context of medical devices, a Notified Body is an independent organisation designated by a European Union (EU) member state to assess and verify the conformity of certain products with the applicable regulatory requirements. 

Notified Bodies play a crucial role in the conformity assessment process – a key step for placing medical devices on the EU market – and undertake multiple other important functions, including:

• Conformity Assessment
• QMS Audits
• Product Certification
• Ongoing Surveillance
• Technical Expertise

An Approved Body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK medical devices regulations).

Yes. If you're prepared to bring a medical device to market, our team can guide you through the FDA approval process. Being well-versed in the intricacies of the FDA submission process, including 510(k), De Novo, PMA, STeP and Breakthrough Device Program Submissions, our team can help ensure a smooth journey, steering clear of any potential regulatory pitfalls.

Yes, we can help manufacturers achieve regulatory compliance by acting as your authorised representative and allowing you to access the EU market. We will act as your regulatory representative in the European Single Market and will be the point of contact between you and the competent authorities.

A Clinical Evaluation Report (CER) is a comprehensive document that systematically assesses and summarises the clinical data about a medical device. The primary purpose is to demonstrate the device's safety and performance based on clinical evidence throughout its entire lifecycle. 

CERs are crucial components of the regulatory submission process and play a key role in obtaining and maintaining regulatory approval or certification for medical devices. At Apotech, we can provide a comprehensive medical writing service and deliver a customised service that caters to the unique requirements of both Medical Device and IVD manufacturers.