By Dafydd Taylor, Bayer
In 1993 the Medical Devices Directive (MDD) published the following definition of medical device:
“‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;”
Given that the majority of self care devices within PAGB Membership are substance based devices, the final part of the definition is key. It meant that substance based products that were ingested or applied topically and that achieved their principle intended action by a physical means, for example forming a barrier, could be classified as medical devices.
Over time, it became clear that there were many substance based products that met this definition. If you look through PAGB’s OTC Directory you will be able to find medical devices in almost every OTC therapeutic category; for treating symptoms of cold and flu, congestion, pain, dry skin, eczema, cracked skin, IBS related symptoms, head lice, mouth ulcers, dental heath, itchy eyes, earwax, verrucas, cold sores, bacterial vaginosis, psoriasis and fungal nail infections.
For many years the MDD worked well but with advances in the sector, inconsistency in the application of the Directive and some high profile scandals, opinion was shifting and in 2012 work began on drafting a new set of rules, the Medical Devices Regulation.
Excerpt from the European Commission: –
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
“The existing regulatory framework has demonstrated its merits but has also come under harsh criticism, in particular after the French health authorities found that a French manufacturer (Poly Implant Prothèse, PIP) had for several years apparently used industrial silicone instead of medical grade silicone for the manufacture of breast implants contrary to the approval issued by the notified body, causing harm to thousands of women around the world.
In an internal market with 32 participating countries and subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the Directives, i.e. the safety of medical devices and their free movement within the internal market. Moreover, regulatory gaps or uncertainties exist with regard to certain products (e.g. products manufactured utilising non-viable human tissues or cells; implantable or other invasive products for cosmetic purposes).
This revision aims to overcome these flaws and gaps and to further strengthen patient safety. A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit for purpose’. This framework should be supportive of innovation and the competitiveness of the medical device industry and should allow rapid and cost-efficient market access for innovative medical devices, to the benefit of patients and healthcare professionals.”1
This was the political and regulatory environment as PAGB delved into the world of self care medical devices, with the draft text threatening to reclassify all substance based medical devices under the higher risk classification (Class III).
After many rounds of comments on drafts, meetings with the Association of the European Self-Medication Industry (AESGP), Medicines and Healthcare Products Regulatory Agency (MHRA) and a meeting with co-rapporteur Dame Glenis Willmott MEP to argue for a proportional approach, the Medical Device Regulation was finally published in the Official Journal and entered into force on 25 May 2017.
Today, Rule 21 of the MDR provides a tiered approach to the classification of substance based devices. Classification is based on where the product is applied and whether it or its products of metabolism are systemically absorbed by the human body.
Rule 21: –
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:
class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose;
class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body;
class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities; and
class IIb in all other cases.2
This rule has continued to be the subject of much deliberation both at PAGB and at AESGP medical device groups when considering the impact for different product types. Representatives from both groups met with MHRA colleagues last year to discuss the AESGP position on the interpretation of Rule 21 and the outstanding questions which needed to be resolved by the European Commission’s Medical Devices Borderline and Classification working group. We are still awaiting guidance from that group.
This is not the only outstanding guidance. Now, two years of the three-year transition period have already elapsed, and we continue to wait for the publication of many Implementing Acts and Guidance required for consistent implementation of the MDR. Unique Device Identification (UDI), vigilance & surveillance, Eudamed and MDR text interpretations are regularly discussed at the PAGB Medical Devices Group.
Notified Body capacity is still a serious concern. On 22 May 2019, TÜV SÜD became only the second notified body to be designated under the MDR (BSI was designated in January), by comparison, there are currently 58 Notified Bodies designated under the Directives.
With the process for medical device certification by a notified body expected to take up to nine months, possibly even longer as Notified Bodies work with the new Regulations for the first time, it is clear that many medical devices are not going to be certified in time for MDR implementation in May 2020.
These delays should not only be a concern for manufacturers and distributers but also for patients and healthcare providers. As MedTech Europe put it in an open letter to the European Commission in April 2019: –
“the new regulatory system will not be ready on time to ensure continued access of patients and healthcare systems to life-saving and life-transforming devices.
Our industry is prepared to submit product files to comply with the new Medical Device Regulation (MDR). However, we cannot do so. The new regulatory system is not ready to function.”3
Although, the transition provisions outlined in Article 120 of the MDR permit manufacturers to continue to place products on the market until their valid certificates expire, this is not the case for those products which will be classified differently under the MDR and therefore, will need to be certified by a notified body before May 2020.
Manufacturers of reclassified products will not have a valid certificate to enable them to place the product on the market after application of the MDR. For them, 26 May 2020 is a hard deadline.
Twelve months isn’t a long time to prepare for changing regulations, but if the MDR is to be implemented on time then we are all going to be very busy.
Busy reading, understanding and acting on Implementing Acts and Guidelines, busy submitting technical documentation and responding to questions raised by our Notified Bodies, busy inputting data into Eudamed, updating labelling, undertaking our extended vigilance and surveillance responsibilities and perhaps busy with new requirements post Brexit.
With all of this to look forward to in the next year I am thankful to have the support of the PAGB Medical Devices Group which continues to develop into a forum where we can bring questions and concerns, share experience, knowledge and understanding and challenge interpretations.
I’m also happy to know that we have two engaged trade associations in PAGB and AESGP that are working to ensure that the voice of our small section of the medical device industry is heard both in London and Brussels.
Though the self care medical devices category was only recently brought into PAGB membership, the support and impact that it has made is already evident. This is certainly an area where PAGB is an expert in its field and the voice of the industry. Congratulations to PAGB on its centenary. I wish the Association good health for many years to come.
By Dafydd Taylor, Bayer