Medical Devices (‘MD’) are products or equipment intended generally for a medical use and include a vast range of products.
There are three general groups of MD:
- General MDs, e.g., X-ray equipment
- Active implantable MDs, e.g., cochlear implants
- In Vitro Diagnostic Devices e.g., test reagent or control material, diagnostic instruments.
The design and development of a new MD or an improvement to an existing MD and the manufacturing processes will unsurprisingly qualify as Research & Development (‘R&D’). However, complying with regulations to make sure the device is safe and effective to use is imperative and often a major hurdle faced by MD manufacturers when seeking to place a product on the market and often requires R&D to take place.
To add to this challenge, each country has its own MD Regulations (‘MDRs’) and in the UK and EU there have been recent significant changes to update and harmonise EU laws on MDs. These came into effect in May 2021 and during the transitional exit of the UK from the EU. Additionally, the new European In Vitro Diagnostic Regulation (‘IVDR’), is set to become a requirement in May 2022.
The changes include an increase to the scope of devices covered under MDR’s, stricter procedures, increased clinical testing and supply chain oversight. All these activities can potentially result in the requirement for innovative changes to product design, manufacturing, and testing.
Examples of the types of R&D activities required to comply with MD or IVDD regulations
1) To approve and certify the sterility and metrology processes used in the manufacturing process to produce the device, by an approved body including;
- Re design and development of the manufacturing process.
- Testing at specialist approved laboratories following appreciable technical changes to the design or manufacture
- Indirect activities relating to the gathering and analysis of technical data
2) Quality assurance testing, as part of the R&D project.
3) Clinical investigations as part of the R&D project.
More device types have been added to the list of MD and IVDDs including implants, reagents and software and devices for aesthetic and other non-medical purposes including, contact lenses and liposuction.
Is your product now classed as a MD or IVDD, thus requiring conformity testing to be carried out which may require R&D to achieve?
Stricter procedure assessments
Have you had to carry out external testing at a certified laboratory or test your manufacturing process to comply with the regulations?
If your product is an IVDD, does it now fall into a category that requires you to carry out conformity assessments by a notified body?
Clinical Evidence
Have you tested your new product to generate clinical evidence and data to demonstrate the performance and safety of a device?
Have you had to generate further clinical evidence to satisfy the new clinical evidence requirements for an existing Device?
Supply chain oversight
Have you had to research components or materials from alternative suppliers used in the manufacture of your device due to the new requirements for economic operators, including the manufacturer as well as importers to cover the supply chain for MDs and IVD’s?
If the above questions have got you thinking and you feel like you may have eligible R&D activities to consider, as a result of the changes to MD and IVDD regulations, please get in touch with one of our R&D specialists.